Financial Performance - The company reported a revenue of $150 million for the fiscal year 2024, representing a 25% increase compared to the previous year[4]. - The company reported a revenue of HK$124.4 million for the year ended December 31, 2024, reflecting a year-on-year increase of 15%[10]. - In 2024, the company's revenue was RMB 445.6 million, a decrease of approximately 29.8% compared to 2023[42]. - The total comprehensive loss for the year was RMB 199.4 million, a significant improvement from a loss of RMB 562.5 million in 2023[143]. - The gross profit fell by 30.2% from RMB 585.8 million in 2023 to RMB 409.1 million in 2024, with a gross profit margin of 91.8% compared to 92.3% in the previous year[148]. - Other income and net gains increased to RMB 54.7 million in 2024 from RMB 41.0 million in 2023, driven by higher bank interest income, foreign exchange gains, and investment income[149]. User Growth and Market Expansion - User data showed a growth of 30% in active users, reaching 1.2 million by the end of the fiscal year[4]. - The user base expanded by 20% year-on-year, reaching a total of 1.2 million active users[10]. - The company is expanding its market presence in Southeast Asia, targeting a 10% market share within the next two years[4]. - The company plans to enter the North American market by Q3 2025, aiming to capture a 10% market share within the first year[10]. Research and Development - Research and development expenses increased by 30% to HK$37 million, focusing on innovative drug development[10]. - Research and development expenses were RMB 180.7 million, representing a 57.5% decrease from 2023[26]. - The company has made significant progress in its R&D pipeline, adding a new mRNA vaccine candidate and a radiopharmaceutical candidate in 2024[46]. - The company is actively developing early-stage pipeline candidates while strategically expanding its commercial portfolio to transform cancer into a manageable chronic disease[48][49]. - The company has established an ionizable cationic lipid R&D platform to enhance mRNA vaccine development efficiency and improve drug targeting precision[98]. Product Development and Innovation - New product launches contributed to 15% of total revenue, with the introduction of two innovative therapies in the oncology sector[4]. - The company has diversified its product pipeline to include 13 products, with the addition of the new radiopharmaceutical drug conjugate (RDC) 3D1015[25]. - The company is developing a proprietary AI-driven antigen prediction platform for tumor antigen screening and design for 3D124[94]. - The company has initiated the development of next-generation radioligand therapy products, leveraging PSMA as an entry point[112]. Cost Management and Operational Efficiency - The management highlighted a 5% reduction in operational costs due to improved efficiency measures implemented during the year[4]. - Administrative expenses decreased by RMB 138.8 million to RMB 78.3 million from RMB 217.1 million in 2023, primarily due to a reduction in share-based payment expenses[156]. - Selling and marketing expenses decreased by 37.7% from RMB 378.8 million in 2023 to RMB 235.9 million in 2024, reflecting a more effective sales promotion regime and cost reduction measures[157]. Strategic Partnerships and Acquisitions - A strategic acquisition of a biotech firm was completed, expected to enhance the company's R&D capabilities and product pipeline[4]. - The company has secured partnerships with three major pharmaceutical firms to enhance its distribution network[10]. - The company is exploring potential acquisitions to bolster its product pipeline and market presence[10]. Sustainability and Corporate Responsibility - The company is committed to sustainability, with a goal to reduce carbon emissions by 30% over the next five years[4]. - The company integrated Environmental, Social, and Governance (ESG) principles into its daily operations[25]. Clinical Development and Regulatory Progress - A new drug application (NDA) is expected to be submitted to the NMPA by the end of Q2 2025, targeting renal cell carcinoma[10]. - The execution team secured a Breakthrough Therapy designation from Chinese regulators, enhancing the company's strategic position[46]. - Envafolimab received Breakthrough Therapy Designation for treating unresectable or metastatic TMB-H solid tumors, addressing a critical unmet medical need in China[62]. Manufacturing and Infrastructure - The company has purchased land in Xuzhou, China, with an area of 65,637.97 square meters for building new manufacturing facilities, which have received construction permits and are currently under construction[118]. - Approximately 40% of the net proceeds from the 2023 Placing will be allocated to expedite the construction and procurement of new equipment for the manufacturing facilities in Xuzhou[120].

Financial Performance - For the fiscal year ending December 31, 2024, the company's revenue decreased by 29.8% to RMB 445.6 million from RMB 634.9 million in 2023, primarily due to intensified market competition [10]. - The company's gross profit fell by 30.2% to RMB 409.1 million, with a gross margin of 91.8% for 2024, slightly down from 92.3% in 2023, attributed to increased sales-related taxes and product quality costs [8]. - The total comprehensive loss for the year narrowed to RMB 199.4 million from RMB 562.5 million in 2023, indicating improved operational efficiency [13]. - The company reported a pre-tax loss of RMB 199.4 million in 2024, a significant improvement from a loss of RMB 562.5 million in 2023 [54]. - The company reported a net loss of RMB 199.4 million for the year ended December 31, 2024, compared to a net loss in the previous year [107]. - Basic and diluted loss per share for the year was RMB 0.75, compared to RMB 2.30 in 2023, showing a reduction in loss per share [102]. - Total liabilities decreased to RMB 512.5 million in 2024 from RMB 558.2 million in 2023, reflecting a decline of about 8.2% [104]. - The company's equity decreased to RMB 703.7 million in 2024 from RMB 870.7 million in 2023, a drop of approximately 19.2% [104]. Research and Development - Research and development expenses decreased by 57.5% to RMB 180.7 million from RMB 425.5 million in 2023, mainly due to reduced third-party contractor fees and employee benefit costs [11]. - The company has a diversified product pipeline with 13 products, including a new drug candidate 3D1015 aimed at treating metastatic castration-resistant prostate cancer [15]. - The company is leveraging an AI-driven antigen prediction platform for the development of personalized cancer vaccines [15]. - The establishment of an AI-driven 3D-PreciseAg antigen prediction platform has led to the identification of 24 antigens for a universal mRNA tumor vaccine [16]. - The company achieved significant progress in its R&D pipeline, adding a new mRNA vaccine candidate, 3D124, and replacing 3D011 with 3D1015, both showing positive signals in preclinical trials [22]. - The company has filed a PCT patent for key components of its self-developed lipid nanoparticles for nucleic acid drug delivery, indicating ongoing innovation in drug delivery technologies [22]. - The company is actively expanding its research and development efforts in innovative therapies, as evidenced by the promising results from multiple clinical trials [10][11][12][13][14][33][34][35]. Sales and Marketing - Sales and marketing expenses dropped by 37.7% to RMB 235.9 million from RMB 378.8 million in 2023, as new promotional strategies and cost-cutting measures were implemented [12]. - The sales revenue of Envida® (Envafolimab) in China reached RMB 4.456 billion in 2024, contributing to a total sales amount of approximately RMB 1.7 billion [21]. - The total revenue of the group decreased by approximately 29.8% compared to the same period in 2023, primarily due to a decline in Envida® sales [21]. - The company has initiated international commercialization efforts, with a licensing agreement for Envafolimab with Glenmark, allowing entry into the Macau market, which is expected to provide new revenue growth opportunities [22]. - The company plans to expand the development and commercialization of Envidat® into emerging markets through strategic partnerships [77]. Clinical Trials and Approvals - A total of 22 prospective research results related to Envida® were published in 2024, including 5 full papers in international high-level journals and over 17 reports at international conferences [18]. - Envafolimab has been recognized as a breakthrough therapy for patients with high tumor mutation burden (TMB-H) unresectable or metastatic solid tumors [20]. - The company received approval for a supplemental new drug application (sNDA) to change the production scale from 1000L to 2000L and to add new raw material suppliers [20]. - The clinical data for Envafolimab combined with Lenvatinib for treating advanced endometrial cancer showed improved efficacy and safety for patients who failed or could not tolerate prior platinum-based chemotherapy [26]. - The ENLIGHTEN study reported an Objective Response Rate (ORR) of 45% and a Disease Control Rate (DCR) of 80% in advanced biliary tract cancer patients [26]. - Envafolimab demonstrated a pathological complete response (pCR) rate of 30.7% and a major pathological response (MPR) rate of 53.8% in a study involving resectable stage II-IIIB NSCLC patients [28]. - The combination therapy of TACE, Envafolimab, and Lenvatinib for unresectable hepatocellular carcinoma (uHCC) demonstrated an ORR of 50% and a DCR of 83.3%, with a surgical conversion rate of 47.2% and a 100% R0 resection rate [11]. Corporate Governance and Strategy - The company adheres to high standards of corporate governance and has complied with all applicable code provisions during the reporting period [86]. - The board believes that the current structure of having the same individual as both Chairman and CEO does not impair the balance of power and authority [87]. - The company plans to retain all future earnings for business operations and expansion, with no immediate plans for a dividend policy [88]. - The company has established a comprehensive quality management system based on GLP, GCP, and GMP standards to ensure compliance from early development to final product launch [46]. - The company is focused on expanding its research and development capabilities in cell gene therapy and oncology [129]. Future Outlook - The company anticipates continued progress in advancing late-stage clinical drugs to NDA stage, which is expected to bring incremental cash flow in the foreseeable future [69]. - The company plans to submit multiple IND applications in various countries this year, indicating a strong pipeline for future product development [25]. - The company projects a revenue growth of 20% for the next fiscal year, driven by new product launches and market expansion [132]. - The company aims to reduce operational costs by 15% over the next two years through process optimization [132].

Financial Performance - 3D Medicines reported a significant increase in revenue, reaching approximately HK$ 150 million for the first half of 2024, representing a 25% growth compared to the same period last year[1]. - The company reported a total revenue of RMB 1,200,000,000 for the first half of 2024, reflecting a year-over-year growth of 15%[11]. - For the six months ended June 30, 2024, the company's revenue decreased by 41.4% to RMB 206.4 million from RMB 352.6 million for the same period in 2023, primarily due to a highly competitive market for PD-1/L1 products[16]. - The total comprehensive loss for the period was RMB 114.1 million, a 40.0% improvement from RMB 190.2 million in the same period of 2023[16]. - The company reported a net loss of RMB 150,000,000 for the first half of 2024, compared to a net loss of RMB 120,000,000 in the same period last year[11]. - The total comprehensive loss for the period ended June 30, 2024, was RMB (114,074) thousand, a 40.0% improvement compared to RMB (190,204) thousand for the same period in 2023[22]. - The company reported a basic and diluted loss per share of RMB 0.42 for the period, compared to RMB 0.79 in the same period last year[150]. Research and Development - 3D Medicines is investing heavily in R&D, allocating approximately HK$ 50 million for the development of new therapies, including a focus on PD-L1 inhibitors[1]. - Research and development expenses for the first half of 2024 were RMB 300,000,000, representing an increase of 25% compared to the same period last year[11]. - Research and development expenses decreased by 43.7% to RMB 85.3 million from RMB 151.6 million, mainly due to a reduction in employee benefit expenses related to research and development personnel[17]. - The company has a pipeline of 12 drug candidates, with seven in various stages of clinical development[23]. - The company is focusing on cutting-edge research in TIL and CAR-T therapies to promote diversification and specialization of its research and development[29]. Market Expansion and Strategy - The company is actively expanding its market presence, with plans to enter two new international markets by the end of 2024[1]. - The company plans to expand its market presence in Asia, targeting a 30% increase in market share by the end of 2025[11]. - Future guidance indicates an anticipated revenue growth of 20% for the full year 2024, driven by new product introductions and market expansion efforts[11]. - The company aims to enhance its digital marketing strategies, targeting a 40% increase in online engagement with healthcare professionals by mid-2025[1]. Product Development and Clinical Trials - The company is on track to submit a biologic license application (BLA) for Envafolimab by Q4 2024, which is expected to accelerate its market entry[1]. - Envafolimab achieved sales revenue of RMB 206.4 million in China for the six months ended June 30, 2024, a decrease of 41.4% compared to the same period last year[23]. - Envafolimab's phase III trial in NSCLC perioperative regimens is progressing smoothly[23]. - The confirmed overall response rate (ORR) for Envafolimab combined with Lenvatinib in advanced endometrial cancer was 40.0%[24]. - The ongoing Phase III trial (KN035-CN-017) is assessing the efficacy and safety of Envafolimab in combination with neoadjuvant platinum-based chemotherapy, with a focus on patients with resectable NSCLC[30]. Cost Management and Operational Efficiency - 3D Medicines reported a 15% reduction in operational costs due to improved manufacturing efficiencies[1]. - The company aims to reduce operational costs by 10% over the next year through efficiency improvements and strategic partnerships[11]. - Selling and marketing expenses decreased by 50.2% to RMB 110.1 million from RMB 221.0 million, primarily due to a sales drop of Envafolimab, with the decrease rate of marketing expenses exceeding the sales decline rate[18]. Financial Position and Cash Flow - As of June 30, 2024, cash and bank balances amounted to RMB 898,578,000, a decrease of 19.8% compared to RMB 1,120,849,000 as of December 31, 2023[14]. - Current assets as of June 30, 2024, were RMB 1,037.0 million, a decrease from RMB 1,095.2 million as of December 31, 2023[67]. - Cash and cash equivalents decreased by RMB 177.8 million to RMB 488.7 million as of June 30, 2024, from RMB 666.5 million as of December 31, 2023[68]. - Net cash used in operating activities for the six months ended June 30, 2024, was RMB 223.6 million, up from RMB 168.1 million in 2023[70]. Corporate Governance - The company has complied with all applicable code provisions of the CG Code during the reporting period, with some deviations noted[87]. - The roles of chairman and chief executive are held by the same individual, Dr. Gong Zhaolong, which deviates from the CG Code[87]. - The board structure includes three independent non-executive directors out of seven, ensuring sufficient checks and balances[88]. Shareholder Information - Dr. Gong holds a total of 35,992,364 shares, representing approximately 13.94% of the company's shareholding interest[92]. - The shareholding structure indicates a significant concentration of ownership among key directors and their affiliates[93]. - The company has established a share option scheme to incentivize key employees, approved on June 26, 2023[7].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 206.4 million, a decrease of 41.4% from RMB 352.6 million in the same period of 2023[2]. - Gross profit for the same period was RMB 188.9 million, down 41.9% from RMB 325.3 million, with a gross margin of 91.5% compared to 92.3% in the previous year[3]. - The adjusted total comprehensive loss for the period was RMB 97.7 million, an increase of 19.9% compared to RMB 81.5 million in the same period of 2023[5]. - The company reported a pre-tax loss of RMB 114.1 million, a reduction of 42.6% from RMB 190.2 million in the previous year[2]. - Total comprehensive loss for the six months ended June 30, 2024, was RMB 114.1 million, a decrease of RMB 76.1 million from RMB 190.2 million in the same period of 2023[38]. - Basic and diluted loss per share improved to RMB (0.42) from RMB (0.79) year-on-year[73]. Expenses - Research and development expenses decreased by 43.7% to RMB 85.3 million from RMB 151.6 million, primarily due to reduced employee benefits costs[4]. - Sales and marketing expenses fell by 50.2% to RMB 110.1 million from RMB 221.0 million, attributed to decreased sales of the product Envidat®[4]. - The company’s sales cost decreased by 36.0% to RMB 17.5 million from RMB 27.3 million, reflecting reduced sales volume[3]. - Administrative expenses reduced by RMB 34.9 million to RMB 43.5 million for the six months ended June 30, 2024, compared to RMB 78.4 million in the same period of 2023[35]. - Licensing fees decreased by RMB 19.5 million to RMB 15.6 million for the six months ended June 30, 2024, compared to RMB 35.1 million in the same period of 2023[37]. Cash and Assets - Cash and bank balances decreased by 19.8% to RMB 898.6 million from RMB 1,120.8 million as of December 31, 2023[2]. - Total assets as of June 30, 2024, were RMB 1,263,535 thousand, down from RMB 1,428,882 thousand as of December 31, 2023[58]. - Cash and cash equivalents decreased from RMB 666.5 million as of December 31, 2023, to RMB 488.7 million as of June 30, 2024, a reduction of RMB 177.8 million[41]. - Total equity as of June 30, 2024, was RMB 772,866 thousand, down from RMB 870,685 thousand at the end of 2023[59]. Market and Competition - The decline in revenue was primarily due to increased competition in the PD-1/L1 market[3]. - The total revenue for the group decreased by approximately 41.4% compared to the same period in 2023, primarily due to the decline in Envafolimab sales[8]. - Major customer A contributed RMB 86,014 thousand to revenue, accounting for 41.6% of total revenue, compared to RMB 147,848 thousand in the previous year[65]. Product Development and Pipeline - The company has a pipeline of 12 candidate drugs, with two-thirds currently in clinical development, indicating a high maturity level of the pipeline[9]. - The company is focusing on external collaborations, particularly in TIL and CAR-T therapies, to diversify and specialize its research and development efforts[9]. - The company anticipates the continuous launch of new products over the next three to five years, leveraging its mature product pipeline[9]. - Envafolimab (恩維達®) generated sales revenue of RMB 206.4 million in China for the six months ended June 30, 2024, a decrease of 41.4% compared to the same period last year[6]. - The company is developing a new mRNA cancer vaccine, 3D124, which targets multiple tumor-specific antigens and has shown strong anti-tumor effects in preclinical studies[18]. Regulatory and Compliance - Envafolimab (KN035) received regulatory approval in Macau for treating adult patients with unresectable or metastatic MSI-H or dMMR solid tumors[12]. - The company has received orphan drug designation from the FDA for candidate drugs 3D185 and 3D189, targeting specific cancers[47]. - The company has complied with all applicable corporate governance codes, except for the separation of the roles of Chairman and CEO, which are held by the same individual[52]. Strategic Initiatives - The company aims to enhance its product pipeline through global drug development initiatives[47]. - The company plans to implement improved sales strategies to drive growth, especially after expanding Envafolimab's indications[8]. - The company is focused on expanding its market presence in the oncology sector, particularly in non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC)[79]. - The company is actively monitoring market trends to inform future product development and expansion strategies[79].

Financial Overview - The total expected amount for product and drug candidates development is RMB 232,927.9 thousand, with core product envafolimab accounting for RMB 128,110.3 thousand[4]. - The total budget for the development and commercialization of products and drug candidates is set to reach RMB 232,927.9 thousand by December 2025[4]. - The company generated revenues of RMB634.9 million in 2023, a significant increase from RMB567.4 million in 2022, reflecting a year-on-year growth of approximately 11.5%[91]. - Total comprehensive loss for 2023 was RMB562.5 million, a reduction from RMB1,052.0 million in 2022, indicating improved financial performance[91]. - Total assets as of December 31, 2023, were RMB1,428.9 million, compared to RMB1,332.1 million in 2022, showing a growth of approximately 7.2%[89]. - Total liabilities stood at RMB1,000.0 million as of December 31, 2023, reflecting an increase from RMB900.0 million in 2022[89]. - The company reported stable profit margins alongside sales growth of 11.9%[100]. - The increase in other income and gains was recorded at RMB41.0 million for the year ended December 31, 2023, compared to RMB48.9 million for the same period in 2022[192]. - Total comprehensive loss decreased by 46.5% from RMB 1,052.0 million in 2022 to RMB 562.5 million in 2023[196]. - Adjusted total comprehensive loss for the year was RMB 263.6 million in 2023, compared to RMB 253.2 million in 2022[198]. Research and Development - The overall strategy includes a focus on research and development to drive future growth and market expansion[4]. - Research and development expenses amounted to RMB425.5 million, representing a 21.3% increase from RMB350.9 million in 2022[91]. - The company is focused on augmenting its internal discovery capabilities and conducting pivotal clinical trials to optimize treatment options for cancer patients[93]. - The company is developing next-generation cancer vaccines, including peptide and mRNA cancer vaccines, which aim to activate CD8+ T cells for improved patient outcomes[122]. - The phase I clinical trial for the FIC cancer peptide vaccine targeting WT1 (3D189) has completed patient enrollment[122]. - The mRNA cancer vaccine 3D124 is currently in the pre-clinical development stage, utilizing a unique AI algorithm to enhance its efficacy[122]. - The company is developing four drug candidates in the IND-enabling stage, enhancing its R&D capabilities[176]. - The R&D platform has strong molecule screening and design capabilities to enhance success rates in drug development[154]. Product Development and Commercialization - The company plans to conduct more clinical studies to advance the commercialization of its products, including Envafolimab[189]. - The company aims to maximize the commercial value of Envafolimab through independent clinical trials and collaborations with partners outside of China[189]. - The company is strategically collaborating with partners to expand into emerging markets for the development and commercialization of 恩維達®[161]. - The commercialization network includes 30 provinces, 312 cities, 1,300 hospitals, and 1,100 pharmacies[100]. - The company has proven its internal research and development capabilities in innovative products, further solidifying its market position[161]. - The company is working with qualified CMOs to manufacture and test drug candidates for pre-clinical and clinical supply[182]. - The company has established R&D centers in Shanghai and Beijing, focusing on chronic cancer treatment[182]. Employee Incentives and Share Options - The Share Option Scheme was adopted on June 26, 2023, to attract and retain high-quality employees and enhance performance[24]. - The Company aims to motivate eligible participants through the Share Option Scheme to optimize their performance for the benefit of the Group[24]. - The RSU Scheme is valid for ten years, with approximately 7.47 years remaining as of December 31, 2023[37]. - The vesting schedule allows for 25% of the awards to vest after 12 months, 50% after 24 months, 75% after 36 months, and 100% after 48 months from the grant date[43]. - The Company emphasizes maintaining flexibility in the range and nature of rewards offered to eligible participants[24]. - The ESOP Department has the discretion to grant RSUs based on performance conditions and other criteria[40]. Sales Performance - Sales revenue from Envafolimab reached RMB 634.9 million, representing a year-on-year growth of 11.9%[61]. - Envafolimab received market approval in Macau and was included in three NCCN guidelines[61]. - The company anticipates stable sales growth for Envafolimab due to ongoing efforts in research and development and commercialization[61]. - Continuous efforts in research, development, and commercialization are anticipated to lead to stable growth in 恩維達® sales[84]. - Envafolimab achieved remarkable sales revenue of RMB 634.9 million in China for the year ended December 31, 2023, representing a growth rate of 11.9% compared to the same period last year[100]. Regulatory and Market Approvals - Envafolimab received approval from the FDA for a Phase III study in endometrial cancer on October 28, 2023[100]. - On November 24, 2023, Envafolimab was granted breakthrough therapy designation by the NMPA for advanced endometrial cancer[101]. - The company has received NDA approval for the treatment of previously treated MSI-H/dMMR advanced solid tumors on November 24, 2021, and is actively selling Envafolimab through pharmacy operating companies and distributors[157]. - The FDA granted orphan drug designation for 3D185 for the treatment of gastric cancer and gastroesophageal junction cancer on January 13, 2023[142]. Strategic Partnerships and Collaborations - The company is strengthening its strategic partnership with Innolake Biopharm (Hangzhou) Co. Ltd.[149]. - On January 26, 2024, a strategic cooperation agreement was signed with Qingdao Sino-Cell Biomedicine Co., Ltd. to enhance oncology immunotherapy research[153]. - A strategic cooperation signing ceremony with Novatim was held on February 21, 2024, focusing on the combination of Envafolimab and KY-0118[153]. Awards and Recognition - The company received the "Outstanding Healthcare Enterprise of the Year" Award on December 21, 2023[186]. - In November 2023, 3D Medicines was listed in the "Top 100 Chinese Pharmaceutical Innovation Enterprises" and the "Top 20 ESG Competitiveness of Chinese Listed Pharmaceutical Companies"[158]. - This is the second consecutive year that 3D Medicines received the "Top 100 Chinese Pharmaceutical Innovation Enterprises" title and the first ESG-related award since its listing[158].

Sales Performance - 3D Medicines Inc.'s first commercial product, Envida®, has accumulated sales exceeding RMB 1 billion[5] - The sales growth rate for Envida® in 2023 was 11.9%, surpassing the growth rate of sales and marketing expenses[5] Expenses - Sales and marketing expenses increased by 5.9% from RMB 357.7 million for the year ended December 31, 2022, to RMB 378.8 million for the year ended December 31, 2023[5]

Financial Performance - The net cash used in operating activities for the year ended December 31, 2023, was RMB 144.4 million, compared to RMB 278.8 million for 2022[1]. - The company reported a basic and diluted loss per share of RMB (2.30) for 2023, compared to RMB (22.52) for 2022[28]. - The total comprehensive loss for the year decreased by 46.5% to RMB 562.5 million in 2023 from RMB 1,052.0 million in 2022, indicating improved financial performance[87]. - Adjusted total comprehensive loss for the year was RMB 263.6 million, a 4.1% increase compared to RMB 253.2 million in 2022[92]. - The total comprehensive loss for the year decreased by 46.5% from RMB 1,052.0 million in 2022 to RMB 562.5 million in 2023[92]. Revenue Growth - Revenue from the mainland China market for the year 2023 was RMB 634.9 million, an increase from RMB 567.4 million in 2022, representing a growth of approximately 11.3%[20]. - The company's revenue for the year ended December 31, 2023, increased by 11.9% to RMB 634.9 million from RMB 567.4 million in 2022, reflecting strong sales growth of the product Envidat (Envafolimab) since its launch in 2021[88]. - Envidat® achieved sales revenue of RMB 634.9 million in China for the year ended December 31, 2023, representing an 11.9% increase year-over-year[93]. - The main drivers for revenue and gross profit growth for the year ended December 31, 2023, were the significant increase in sales volume and gross margin of Envida®[76]. Research and Development - Research and development expenses increased by 21.3% to RMB 425.5 million, up from RMB 350.9 million in the same period of 2022[70]. - The company is focusing on developing next-generation tumor immune checkpoint inhibitors and researching mRNA candidates based on its extensive clinical development experience[76]. - The company is committed to enhancing its internal discovery capabilities and conducting critical clinical trials to address unmet clinical needs in cancer patients[76]. - The company is advancing its pipeline with next-generation tumor immunotherapy candidates, including peptide and mRNA tumor vaccines[79]. - The ongoing Phase I clinical study of 3D189, a peptide cancer vaccine targeting WT1 protein, has shown satisfactory progress in safety and immunogenicity among Chinese hematological cancer patients[124]. Clinical Trials and Approvals - The company received IND approval for a Phase III clinical trial of Envidat in combination with platinum-based chemotherapy for resectable stage III non-small cell lung cancer (NSCLC) patients[84]. - The FDA approved a Phase III clinical study for Envidat® in combination with Lenvatinib for the treatment of advanced or recurrent endometrial cancer on October 28, 2023[105]. - The recruitment for the Phase II clinical study of ENVOVIL monoclonal antibody combined with BD0801 for the treatment of advanced solid tumors was completed on March 9, 2023[107]. - The clinical study for the treatment of advanced solid tumors with Envidat® in combination with BD0801 has completed patient recruitment[133]. Strategic Initiatives - The company plans to utilize approximately 50% of the net proceeds from the 2023 placement for clinical trials of the Envorili monoclonal therapy, amounting to RMB 103.7 million[9]. - The construction of the production facility in Xuzhou, China, is expected to utilize 40% of the net proceeds, which is approximately RMB 82.9 million[9]. - The company raised approximately HKD 226.8 million through a placement of new shares in July 2023 to strengthen its financial position and accelerate the development of multiple clinical projects[94]. - The company has established a sales and marketing department focused on the commercialization of pipeline products, covering 1,300 hospitals and 1,100 pharmacies across 30 provinces[163]. Employee and Operational Expenses - The total employee benefits expenses for the year ended December 31, 2023, amounted to approximately RMB 403.7 million[3]. - Administrative expenses increased significantly by RMB 74.3 million to RMB 217.1 million, primarily due to an increase in share-based payment expenses of RMB 85.4 million[200]. - Sales and marketing expenses increased by 5.9% from RMB 357.7 million in 2022 to RMB 378.8 million in 2023, driven by a sales growth rate of 11.9% for Envidat®[91]. Market Position and Product Development - The company has established a pipeline consisting of 12 drugs or candidates, with Envida® being commercialized in mainland China in November 2021 and in Macau in January 2024[76]. - Envidat® has been included in three NCCN clinical practice guidelines and nine Chinese clinical treatment guidelines as of the performance announcement date[94]. - Envidat® has accumulated sales exceeding RMB 1 billion, marking its first commercialized product[152]. - The company holds a broad patent portfolio, including 13 granted patents in China and 18 in other jurisdictions, along with 21 pending patent applications[165].

Financial Performance - Revenue for the six months ended June 30, 2023, increased by 70.3% to RMB 352,553,000 compared to RMB 207,028,000 in the same period of 2022[3]. - Gross profit for the same period rose by 69.6% to RMB 325,252,000, up from RMB 191,824,000 in 2022[3]. - Total comprehensive loss for the period improved by 41.2% to RMB 190,204,000 from RMB 323,553,000 in 2022[3]. - Adjusted total comprehensive loss decreased by 29.9% to RMB 81,454,000 from RMB 116,131,000 year-over-year[3]. - The company reported a significant increase in revenue, achieving $150 million for the first half of 2023, representing a 25% year-over-year growth[10]. - The company provided an optimistic outlook, projecting a revenue growth of 20% for the full year 2023, targeting $300 million[10]. - Total comprehensive loss for the period decreased to RMB (190,204) thousand in 2023 from RMB (323,553) thousand in 2022, representing a reduction of approximately 41%[148]. - Adjusted total comprehensive loss for the period improved to RMB (81,454) thousand in 2023 compared to RMB (116,131) thousand in 2022, indicating a 30% decrease[148]. Research and Development - Research and development expenses decreased by 12.4% to RMB 151,606,000 from RMB 173,135,000 year-over-year[3]. - Future outlook includes continued investment in R&D to drive innovation and potential new product launches[3]. - The company is committed to strict compliance with drug production quality management regulations to ensure product quality and control risks[103]. - The company has a total of 12 drug candidates in its pipeline, with seven in various stages of clinical development[67]. - The company is developing a new generation of tumor vaccines aimed at treating various types of blood and solid tumors, with a global Phase III pivotal MRCT for AML currently ongoing[110]. - The company has developed four drug candidates in the IND-enabling stage, including 3D062, a KRAS mutation inhibitor, with PCT applications submitted on January 17 and March 8, 2023[156][157]. - The company is enhancing rights related to the ILB-2109 project in Mainland China through collaboration with Innolake Biopharm[159]. - The R&D platform includes large and small molecule platforms, cell line screening, and compound screening, aimed at increasing the success rate of drug development[159]. Market Expansion and Strategy - The company is focusing on expanding its market presence and enhancing its product pipeline through ongoing research and development efforts[3]. - The company is exploring strategic partnerships and potential acquisitions to bolster its market position[3]. - The company is expanding its market presence in Southeast Asia, with plans to enter three new countries by the end of 2023[10]. - A strategic acquisition of a local biotech firm was announced, valued at $20 million, aimed at enhancing R&D capabilities[10]. - The company plans to increase its workforce by 10% to support growth initiatives and enhance customer service[10]. - The company continues to focus on expanding its product availability in pharmacies and hospitals to enhance sales growth[57]. - The company is gradually carrying out pre-market preparations for products that are close to commercialization[162]. Sales and Marketing - Selling and marketing expenses increased by 62.8% to RMB 220,969,000 compared to RMB 135,751,000 in the previous year[3]. - The increase in revenue was attributed to the differentiation advantages of 恩維達 ®, broader coverage of pharmacies and hospitals, and strong recognition from doctors and patients[166]. - Sales of 恩維達 ® have covered more than 1,150 hospitals and pharmacies in over 200 cities across 30 provinces in China[162]. - The company has established a dedicated sales and marketing department for the commercialization of its pipeline products[162]. - The strong sales performance of Envafolimab in the first half of 2023 is attributed to its differentiated advantages recognized by doctors, good patient compliance, and strategic collaborations[90]. Clinical Trials and Product Development - The phase Ib/II trial for Envafolimab in combination with Lenvatinib has completed patient enrollment, with preliminary results accepted for presentation at the ESMO Annual Meeting in October 2023[67]. - A phase II clinical trial for Envafolimab monotherapy in subjects with dMMR advanced solid tumors has been approved by the FDA, with preparations underway for patient enrollment in multiple regions[67]. - The ongoing ENVASARC study is currently enrolling patients for a 600mg every three weeks monotherapy with Envolimab, with plans for an interim analysis in Q3 2023[102]. - The objective response rate (ORR) in the clinical trial for 3D229 combined with SOX treatment was 50%, with a disease control rate (DCR) of 87.5%[151]. - The company is awaiting final results from a Phase III trial of 3D229 in combination with paclitaxel for platinum-resistant recurrent ovarian cancer, with ongoing studies in RCC and pancreatic cancer[128]. Financial Position and Cash Flow - Cash and bank balances decreased by 8.3% to RMB 864,236,000 from RMB 942,028,000[6]. - Current liabilities totaled RMB 424.1 million as of June 30, 2023, which includes trade payables of RMB 43.2 million and interest-bearing bank loans of RMB 151.6 million[150]. - As of June 30, 2023, total assets amounted to RMB 1,346.3 million, with total liabilities at RMB 523.7 million[195]. - The Group did not have any material contingent liabilities as of June 30, 2023, indicating a stable financial position[175]. - The net cash used in operating activities was RMB 168.1 million, compared to RMB 85.6 million for the same period in 2022, indicating a significant increase in cash outflow[173]. - The net cash flows from financing activities for the six months ended June 30, 2023, were RMB 76.3 million, primarily from new interest-bearing bank borrowings of RMB 127.6 million, partially offset by repayments of RMB 52.5 million[173].

Financial Performance - For the six months ended June 30, 2023, the company's revenue increased by 70.3% to RMB 352.6 million, compared to RMB 207.0 million for the same period in 2022[14]. - The gross profit for the same period rose by 69.6% to RMB 325.3 million, with a gross margin of 92.3%, slightly down from 92.7% in the previous year[16]. - The total comprehensive loss for the period was RMB 190.2 million, a 41.2% improvement compared to RMB 323.6 million in the same period last year[14]. - The adjusted total comprehensive loss, as per non-IFRS measures, was RMB 81.5 million, down 29.9% from RMB 116.1 million in the previous year[14]. - Revenue for the six months ended June 30, 2023, was RMB 352,553 thousand, representing an increase of 70.4% compared to RMB 207,028 thousand for the same period in 2022[111]. - The company reported a loss before tax of RMB 190,204 thousand, a significant improvement from a loss of RMB 323,553 thousand in the previous year, reflecting a reduction of 41.2%[111]. - Basic and diluted loss per share for the six months ended June 30, 2023, was RMB 0.79, compared to RMB 8.41 for the same period in 2022, showing a substantial decrease in loss per share[128]. Research and Development - The company is developing a next-generation tumor vaccine, with a global Phase III pivotal MRCT for treating AML currently ongoing[11]. - The company has advanced its product pipeline with 12 candidate drugs, including the commercialized Envita® (Envafolimab) and 7 products in various clinical stages, with 3D189 currently in Phase III MRCT[21]. - The company is conducting a Phase III study for 3D189, comparing it with the best available treatment in AML patients, with recruitment ongoing at approximately 105 centers globally[36]. - The company plans to submit an IND application for a Phase III clinical trial comparing Envida® combined with platinum-based chemotherapy against placebo in resectable stage III non-small cell lung cancer patients[55]. - The company is advancing its 3D185 capsule in a Phase I clinical trial, with initial doses showing good safety and tolerability[64]. - The company is conducting a Phase III clinical trial of 3D229 combined with paclitaxel for platinum-resistant recurrent ovarian cancer, with the primary endpoint being progression-free survival (PFS) based on RECIST v1.1 criteria[70]. - The company plans to initiate a pivotal clinical trial in North America for soft tissue sarcoma, with progress reported as smooth[33]. Sales and Marketing - Sales and marketing expenses increased by 62.8% to RMB 221.0 million, driven by a significant increase in sales volume of the product Envidat®[6]. - Envidat® sales in China reached RMB 352.6 million for the six months ended June 30, 2023, marking a 70.3% year-on-year growth[9]. - The marketing strategy focuses on patient needs and emphasizes the differentiated features of Envidat® to enhance the quality of life for cancer patients, which has led to recognition from third-party payers[191]. - The average monthly sales growth of innovative drugs has decreased by 19% post-COVID-19, highlighting the strong performance of Envida® in a challenging market[48]. Financial Position - The company raised approximately HKD 226.8 million through a placement of new shares in July 2023 to strengthen its financial position and accelerate the development of multiple clinical projects[11]. - The total liabilities to total assets ratio increased to 39% as of June 30, 2023, compared to 33% as of December 31, 2022[131]. - The total equity as of June 30, 2023, was RMB 822,600,000, down from RMB 895,414,000 as of December 31, 2022[172]. - The company did not declare any interim dividend for the six months ended June 30, 2023[105]. Regulatory and Compliance - Envafolimab has passed a routine quality supervision inspection with zero defects by the Sichuan Provincial Drug Administration, marking a significant regulatory milestone[31]. - The FDA granted orphan drug designation for the treatment of gastric cancer and gastroesophageal junction cancer, with ongoing development of four IND-stage candidate drugs[38]. - 3D185 has received orphan drug designation from the FDA for the treatment of gastric cancer and gastroesophageal junction cancer, marking its second orphan drug designation[74]. - The company is committed to strict compliance with quality management standards to ensure product quality and safety[57]. Strategic Initiatives - The company was included in the Hong Kong Stock Connect list and selected as a constituent stock of the Hang Seng Composite Index effective March 13, 2023[11]. - The strategic partnership with InnoLake Pharmaceuticals has been strengthened for the ILB-2109 project, focusing on clinical development and medical strategy[77]. - The company has established a robust R&D platform in Shanghai and Beijing to enhance the success rate of molecules advancing from preclinical research to market[78]. - The company is preparing for the commercialization of upcoming products, with pre-launch preparations gradually underway[82]. Customer and Revenue Insights - Major customer A contributed RMB 147,848 thousand in revenue, up from RMB 87,816 thousand in the previous year, while major customer B's revenue increased to RMB 39,065 thousand from RMB 28,245 thousand[118]. - All revenue during the reporting period was derived from customers in mainland China, with nearly all non-current assets located there[173]. - The group reported a revenue of RMB 352,553,000 from customer contracts during the reporting period[142].

Financial Performance - The company reported a total revenue of $150 million for the fiscal year 2022, representing a 25% increase compared to the previous year[1]. - The company provided a forward guidance of $180 million in revenue for the next fiscal year, indicating a projected growth of 20%[1]. - The company reported a net profit margin of 12% for 2022, an improvement from 10% in 2021[1]. - The board announced a dividend payout of $0.05 per share, reflecting a 25% increase from the previous year[1]. - Revenues generated in 2022 amounted to RMB 567.4 million, representing an 841.6% increase from 2021[31]. - Revenue for 2022 reached RMB 567.4 million, a significant increase of 841.6% compared to RMB 60.3 million in 2021, primarily driven by the sales of Envafolimab[154]. - Gross profit rose by 838.1% from RMB 56.0 million in 2021 to RMB 525.2 million in 2022, with a stable gross profit margin of approximately 92.6%[156]. - The total comprehensive loss for the year was RMB 1,052.0 million, a decrease from RMB 1,461.8 million in 2021[150]. User Growth and Market Expansion - User data showed a growth in active users to 1.2 million, up from 900,000 in 2021, marking a 33% increase[1]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by the end of 2024[1]. - The company plans to expand its market presence in Southeast Asia, targeting a XX% increase in market share by the end of 2023[11]. - The company is exploring partnerships with international firms to enhance its global distribution network, potentially increasing sales by XX%[11]. Research and Development - Research and development efforts focused on advancing three new drug candidates, with clinical trials expected to commence in Q2 2023[11]. - The company advanced a pipeline of 12 innovative drugs or drug candidates into the next phase of development[30]. - The company aims to discover, develop, and commercialize innovative drugs for cancer patients requiring long-term treatment[32]. - The R&D platform includes strong molecule screening and design capabilities, enhancing the success rate of moving molecules from pre-clinical studies to market[117]. - The company has filed multiple patent applications for its in-house developed drug candidates, including 3D062, which targets KRAS mutations[110]. Clinical Trials and Approvals - The company is conducting 10 clinical trials, with one pivotal trial approved by the US FDA[26]. - The company is currently conducting 10 clinical trials, with two new INDs approved by NMPA and the US FDA[64]. - A Phase II study for envafolimab in combination with lenvatinib for late-stage non-MSI-H/non-dMMR endometrial cancer has enrolled its first patient and is ongoing as expected[68]. - The company has received IND approval for 3D229 (Batiraxcept) and completed Phase I clinical trials in healthy volunteers[56]. Product Development and Commercialization - New product launches included two innovative therapies, expected to contribute an additional $30 million in revenue in 2023[1]. - The commercialization strategy for Envafolimab includes targeted marketing efforts to improve the quality of life for cancer patients and gain recognition from third-party payers[126]. - The company is building a dedicated sales and marketing department with experience in oncology treatment commercialization to handle product positioning and market strategy[127]. - The company aims to maximize the commercial value of Envafolimab by conducting clinical trials independently and in collaboration with partners outside of China[142]. Financial Position and Cash Flow - Cash and cash equivalents as of December 31, 2022, were RMB 696.7 million, sufficient to fund operations for at least the next two years[31]. - Total current assets as of December 31, 2022, were RMB 1,143.1 million, up from RMB 919.2 million in 2021[190]. - Net cash used in operating activities decreased from RMB 377.1 million in 2021 to RMB 278.8 million in 2022[193]. - The net cash flow from financing activities for the fiscal year ended December 31, 2022, was RMB 408.4 million, primarily due to proceeds from the issuance of common stock amounting to RMB 313.5 million[198]. Strategic Acquisitions and Investments - A strategic acquisition of a biotech firm was completed for $50 million, aimed at enhancing R&D capabilities[1]. - The company invested $10 million in new technology development, focusing on improving production efficiency by 30%[1]. - The company has established in-house production facilities in Xuzhou, Jiangsu province, with a GMP-compliant manufacturing system to support the entire drug development process[124]. Sustainability and Corporate Responsibility - The management highlighted a commitment to sustainability, with plans to reduce carbon emissions by 40% by 2025[1]. - Other expenses rose from RMB 8.9 million in 2021 to RMB 53.4 million in 2022, primarily due to donations worth RMB 51.9 million to a charity supporting cancer patients[179].