Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 254.2 million, a decrease of RMB 7.3 million or 2.8% year-on-year[2] - The company reported a profit of RMB 15.7 million for the six months ended June 30, 2024, compared to a loss of RMB 209.2 million in the same period last year[3] - Gross profit for the first half of 2024 was RMB 172,029 thousand, up 12.1% from RMB 153,437 thousand in the first half of 2023[43] - The net profit for the six months ended June 30, 2024, was RMB 15,699 thousand, compared to a net loss of RMB 209,226 thousand in the same period of 2023[62] - Basic and diluted earnings per share for the current period were RMB 0.012, while the previous period reported a loss per share[62] Cost Management - Research and development expenses decreased from RMB 186.8 million to RMB 66.2 million, a reduction of RMB 120.6 million, primarily due to decreased milestone fees and employee costs[2] - Administrative expenses decreased from RMB 89.2 million to RMB 46.7 million, a reduction of RMB 42.5 million, mainly due to reduced employee costs[3] - Sales and marketing expenses decreased from RMB 131.4 million to RMB 62.8 million, a reduction of RMB 68.6 million, primarily due to decreased employee costs[3] - The company plans to continue focusing on cost reduction strategies and optimizing its operational efficiency moving forward[71] Drug Development and Approvals - The company achieved a significant milestone with the approval of Sugli monoclonal antibody (CEJEMLY®) for use in combination with platinum-based chemotherapy in July 2024[6] - Sugli monoclonal antibody has received approval from the National Medical Products Administration in China for use in treating IV stage NSCLC, III stage NSCLC, R/R ENKTL, ESCC, and GC/GEJC indications[26][27] - The company is conducting a global Phase III trial for Nofazinlimab in combination with LENVIMA® for the treatment of unresectable or metastatic hepatocellular carcinoma[8] - CS5001, a receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate, is currently in its first-in-human trial with encouraging anti-tumor activity observed[8] - The drug "Pujihua" (Pralsetinib) has been approved in China for first-line treatment of locally advanced or metastatic RET fusion-positive NSCLC patients, and is included in 11 clinical guidelines[20] Strategic Partnerships - A strategic collaboration was established with Ewopharma AG for the commercialization of Sugli monoclonal antibody in Switzerland and 18 Central and Eastern European countries, with potential payments up to USD 51.3 million[6] - The partnership with Heng Rui for the exclusive promotion of "Tajihua" in mainland China enhances its market coverage to 97% across 32 provinces and over 20,000 hospitals[21] - The collaboration with Sanofi involves a strategic partnership for Nofazinlimab in mainland China, with an upfront payment of RMB 60 million and potential milestone payments of approximately RMB 100 million[37] - The partnership with Eli Lilly allows for the exclusive promotion of Pralsetinib in mainland China, enhancing market coverage and reducing operational costs[38] Market Presence and Future Plans - Pralsetinib and Acalabrutinib have been included in 15 national guidelines in China for various treatment areas, enhancing their market presence[13] - Upcoming catalysts include the anticipated approval of Sugratolimab in the UK for first-line treatment of stage IV NSCLC in the second half of 2024[14] - The company aims to submit IND applications for multiple candidates, including CS2009, CS5006, CS5005, and CS2011/CS5007, all expected in 2025[14] - The company is focused on advancing its innovative pipeline and maximizing the commercial value of its marketed products[14] Financial Stability - As of June 30, 2024, the company's cash and cash equivalents stood at RMB 678,856 thousand, down from RMB 996,671 thousand at the end of 2023, reflecting changes in liquidity[47] - The debt-to-asset ratio as of June 30, 2024, was 69.5%, a decrease from 72.5% as of December 31, 2023, reflecting improved financial stability[78] - The company has adopted a prudent funding management policy, utilizing multiple sources for operational funding, including service fees and bank loans[76] Clinical Development and Research - The clinical development of CS5001 (ROR1 ADC) has shown promising results, with an overall response rate (ORR) of 55.6% in Hodgkin lymphoma and 50.0% in DLBCL at specific dose levels[24][25] - The company is advancing its immuno-oncology trispecific antibody CS2009, targeting PD-1, CTLA4, and VEGFa, with an IND application expected in 2024 or 2025[33] - The company has demonstrated unique clinical development capabilities through successful collaborations with multinational pharmaceutical companies like Pfizer[19] Shareholder and Corporate Governance - The audit committee, consisting of three independent non-executive directors, has reviewed the financial performance and internal controls, confirming compliance with relevant accounting standards[90] - The company did not recommend a mid-term dividend for the six months ending June 30, 2024, consistent with the previous year[92] - The company expresses gratitude to shareholders, management, employees, business partners, and customers for their support and contributions[93]

Financial Performance - For the year ended December 31, 2023, revenue was RMB 463.8 million, a decrease of RMB 17.5 million or 3.6% year-on-year, primarily due to a decline in drug sales[5]. - Drug sales amounted to RMB 336.7 million, while licensing income increased by RMB 10.1 million or 8.6% to RMB 95.7 million[5]. - The net loss for the year was RMB 367.2 million, a reduction of RMB 535.5 million or 59.3% compared to the previous year, mainly due to significant decreases in employee costs and net gains from the transfer of the Avelumab business[5]. - Non-IFRS net loss for the year was RMB 330.2 million, a decrease of RMB 430.4 million or 56.6% year-on-year[6]. - The company reported a net loss of RMB 367.2 million, significantly improved from a loss of RMB 902.7 million in the prior year[7]. - Total revenue reached RMB 463.8 million, including commercial revenue of RMB 368.1 million, with precision therapy drug sales amounting to RMB 336.7 million and royalties from Sugli monoclonal antibody at RMB 31.4 million[8]. - The company recorded other gains of RMB 199.5 million in 2023, a significant increase from a loss of RMB 0.8 million in 2022, mainly due to the gain from the transfer of the Aifonib business[65]. - The adjusted loss for the year ended December 31, 2023, was RMB (330,241) thousand, a significant improvement from RMB (760,616) thousand in 2022, representing a reduction of approximately 56.5%[71]. Research and Development - R&D expenses decreased by RMB 86.4 million to RMB 527.8 million, mainly due to reduced milestone fees and employee costs[5]. - Non-IFRS R&D expenses, excluding share-based payment expenses, decreased by RMB 24.4 million to RMB 534.7 million[6]. - R&D expenses were RMB 534.7 million, a decrease from RMB 559.1 million in the previous year[7]. - The company is conducting a global Phase III trial for Nofazinlimab in combination with LENVIMA for the treatment of unresectable or metastatic hepatocellular carcinoma[8]. - The company is progressing with the clinical development of CS5001, a ROR1 ADC, showing promising anti-tumor activity in early-phase trials, with dose escalation reaching level 9 without observing dose-limiting toxicities[16][17]. - The company plans to determine the preliminary recommended phase 2 dose for CS5001 in the first half of 2024 and initiate registration trials by the end of 2024[17]. - The company has established three commercial partnerships to enhance strategic focus on future R&D, including a collaboration with 3SBio for the development of Nofazinlimab[9]. - The company is actively pursuing new product development and market expansion strategies to enhance its competitive position in the biotechnology sector[86]. Cost Management - Administrative expenses fell by RMB 66.4 million to RMB 182.7 million, primarily driven by lower employee costs[5]. - Sales and marketing expenses decreased by RMB 128.0 million to RMB 199.3 million, attributed to reductions in employee costs and professional fees[5]. - Non-IFRS administrative and sales & marketing expenses dropped by RMB 151.1 million to RMB 338.2 million, mainly due to lower employee costs and professional fees[6]. - The company continues to focus on cost reduction strategies to improve financial performance moving forward[5]. Partnerships and Collaborations - The company established commercial partnerships in mainland China to enhance commercialization efficiency, including granting exclusive commercialization rights for RET inhibitor Pralsetinib to Elysium in November 2023[10]. - The company is collaborating with Pfizer to advance the commercialization of Sugemalimab in mainland China, which has been upgraded to a first-line recommendation in the CSCO guidelines for NSCLC[15]. - The strategic partnership with 3SBio for the commercialization of nofazinlimab in mainland China was established in November 2023, accelerating its CMC development[27]. - The company has established partnerships with pharmaceutical and biotech companies to enhance commercialization efficiency and focus on R&D[36]. Regulatory Approvals and Clinical Trials - Five new drug applications (NDAs) were approved for Pralsetinib and Sugli monoclonal antibody, expanding their treatment indications[8]. - The company received NDA approval for Shugli monoclonal antibody in first-line treatment of locally advanced or metastatic GC/GEJC (CPS ≥5) from the National Medical Products Administration in March 2024[19]. - The NDA for Shugli monoclonal antibody in first-line treatment of unresectable locally advanced, recurrent, or metastatic ESCC was approved in December 2023[20]. - The GEMSTONE-302 study for IV stage NSCLC showed significant improvement in overall survival (OS) and progression-free survival (PFS) compared to placebo, with results published in the journal Nature Cancer in June 2023[18]. - The company has updated its pricing strategy, with Avelumab included in China's National Medical Insurance Catalog for treating adult patients with unresectable or metastatic gastrointestinal stromal tumors[13]. Leadership and Management - Dr. Yang Jianxin has over 25 years of experience in oncology drug biomedical research and clinical development, previously leading clinical teams at BeiGene, including over ten clinical trials for various cancer therapies[83]. - The company has a strong leadership team with diverse backgrounds in medicine, finance, and biotechnology, which supports its strategic initiatives and market expansion[86]. - The management team has emphasized a commitment to sustainability, aiming for a 50% reduction in carbon footprint by 2025[90]. - The board consists of eight members, including one executive director, four non-executive directors, and three independent non-executive directors[191]. Financial Position and Funding - Cash and cash equivalents and time deposits stood at RMB 1,026.7 million, slightly down from RMB 1,042.1 million year-over-year[7]. - The company raised approximately RMB 338.12 million from a placement of shares on February 15, 2023, which accounted for about 6.61% of the enlarged issued share capital[75]. - The company has obtained new bank loans totaling RMB 350 million in 2023 for operational funding, with repayments of RMB 268.75 million made during the year[81]. - The company may require additional funding to meet operational cash needs, but it may not be able to secure financing on acceptable terms or at all[106]. Corporate Governance - The company has established five board committees to oversee specific areas, including audit, remuneration, nomination, strategy, and investment[185]. - The independent auditor for the consolidated financial statements during the reporting period was Deloitte Touche Tohmatsu[181]. - The company has established compliance policies and procedures to ensure adherence to applicable laws and regulations[175]. - The board believes the combination of executive and non-executive directors is reasonable and appropriate to safeguard shareholder interests[191].

Investment Rating - The report does not specify a clear investment rating for the company [1] Core Insights - The company reported a revenue of 460 million RMB for 2023, with pharmaceutical sales contributing 340 million RMB [2] - The company is focusing on research and development, with plans to initiate a registration trial for CS5001 by the end of 2024 [2] - The company has established multiple commercial partnerships, including exclusive commercialization rights for drugs in mainland China and other regions [2] - The company expects to generate revenues of 400 million RMB, 460 million RMB, and 590 million RMB for the years 2024, 2025, and 2026 respectively [3][10] Revenue Forecast - The company’s revenue for 2023 was 460 million RMB, with projections of 400 million RMB for 2024, 460 million RMB for 2025, and 590 million RMB for 2026 [3][10] - The growth rates for revenue are projected to be -13.60% in 2024, 14.94% in 2025, and 29.05% in 2026 [4] - The company anticipates that the revenue from the drug Pralsetinib will be 220 million RMB, 270 million RMB, and 340 million RMB for the years 2024, 2025, and 2026 respectively [8] Financial Performance - The net profit attributable to the parent company is projected to be -367.23 million RMB in 2024, -437.53 million RMB in 2025, and -443.99 million RMB in 2026 [4] - The earnings per share (EPS) are expected to be -0.29, -0.34, and -0.35 for the years 2024, 2025, and 2026 respectively [4] - The return on equity (ROE) is projected to be -2267.00% in 2024, 104.54% in 2025, and 51.54% in 2026 [4]

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 463.8 million, a decrease of RMB 17.5 million or 3.6% year-on-year[3]. - Revenue from drug sales amounted to RMB 336.7 million, while licensing income increased by RMB 10.1 million or 8.6% to RMB 95.7 million[3]. - Net loss for the year was RMB 367.2 million, a reduction of RMB 535.5 million or 59.3% compared to the previous year[4]. - Gross profit for 2023 was RMB 304,295 thousand, representing a gross margin of approximately 65.5%, compared to RMB 278,378 thousand in 2022[61]. - The company reported a net loss of RMB 367,234 thousand in 2023, significantly improved from a net loss of RMB 902,678 thousand in 2022[61]. - Other income for the year was RMB 50,608,000, significantly higher than RMB 18,722,000 in 2022, marking an increase of 170.5%[73]. - The company incurred a net loss of RMB 337,585,000 for the year, compared to a loss of RMB 568,813,000 in 2022, indicating an improvement[75]. - The company’s total comprehensive loss for the year was RMB 368.0 million, compared to RMB 902.3 million in the previous year, showing a significant reduction in losses[82]. Research and Development - R&D expenses decreased by RMB 86.4 million to RMB 527.8 million, primarily due to reduced milestone fees and employee costs[3]. - The company has established over ten discovery phase projects, including bispecific antibodies and proprietary cell-penetrating therapies, with one bispecific antibody project and one ADC project entering the preclinical candidate stage[8]. - The CS5001 international multi-center clinical trial is progressing rapidly, showing good tolerability and safety in solid tumors and lymphomas[7]. - The pivotal study for Lorlatinib in ROS1-positive advanced NSCLC completed patient enrollment in June 2023, with discussions ongoing for a pre-NDA/NDA submission in February 2024[24]. - The company is focusing on precision therapy drugs and immuno-oncology drug combinations as strategic priorities, achieving significant progress through various initiatives in 2023[49]. - The company has a pipeline of 12 oncology candidates, with 14 NDA approvals since its establishment in 2015, including Aifonib[30]. Clinical Trials and Approvals - Five new drug applications (NDAs) were approved in mainland China for Pralsetinib and Sugliumab, expanding their treatment scope[7]. - Two NDAs are currently under review in the UK and EU for Sugliumab in combination with chemotherapy for first-line treatment of IV stage NSCLC[7]. - The NDA for CS1001 in treating locally advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) has been approved by the National Medical Products Administration (NMPA) in March 2024[17]. - CS1001 has shown statistically significant improvements in progression-free survival (PFS) and OS compared to placebo in the GEMSTONE-303 study, with results presented at the ESMO conference[17]. - The company received NDA approval for the use of Sugli monoclonal antibody in first-line treatment of unresectable locally advanced, recurrent, or metastatic ESCC patients in December 2023[42]. Strategic Partnerships and Collaborations - The company has formed three commercial collaborations to enhance strategic focus on future R&D, including a partnership with Eli Lilly for the commercialization of pralsetinib in mainland China[9]. - The company is closely working with Pfizer to advance the commercialization of sugemalimab in mainland China, which has been upgraded to a first-level recommendation in treatment guidelines[13]. - A strategic partnership with 3SBio for Nofazinlimab in China was established in November 2023, granting exclusive rights for development, registration, production, and commercialization[26]. - The company is actively seeking strategic partnerships to expand commercialization of late-stage drugs and enhance its early product pipeline[51]. Financial Position and Assets - Cash and cash equivalents increased to RMB 996,671 thousand in 2023 from RMB 558,684 thousand in 2022, indicating a growth of approximately 78.4%[62]. - Total assets less current liabilities amounted to RMB 811,661 thousand in 2023, up from RMB 691,945 thousand in 2022[62]. - Total liabilities decreased to RMB 750.2 million in 2023 from RMB 869.4 million in 2022, indicating a reduction in financial obligations[80]. - The company secured new bank loans totaling RMB 350 million during the year ended December 31, 2023, for operational funding[99]. Corporate Governance - The company is committed to high standards of corporate governance and has adhered to all relevant codes during the reporting period[101]. - The board of directors includes Chairman Dr. Li Wei and several executive and non-executive directors[112]. - The presence of independent directors such as Dr. Paul Herbert Chew suggests a commitment to corporate governance[112]. Market and Product Strategy - The pricing strategy for listed products has been updated, with a focus on improving accessibility and affordability, including the inclusion of avapritinib in the National Reimbursement Drug List[11]. - The company aims to maximize the commercial value of mature drugs while advancing its innovative pipeline, focusing on oncology therapies[30]. - The company is exploring collaborations outside of China for several products, including Nofazinlimab[28].

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 261.5 million, an increase of RMB 85.5 million or 53% compared to RMB 161.4 million for the same period in 2022[5]. - Total revenue reached RMB 261.5 million, with precision medicine drug sales amounting to RMB 246.9 million and royalties from Shugli at RMB 14.6 million[7]. - The total comprehensive expenses for the six months ended June 30, 2023, were RMB 210.1 million, compared to RMB 361.6 million for the same period in 2022[54]. - The company reported a net loss of RMB 209,226 thousand for the six months ended June 30, 2023, an improvement from a net loss of RMB 361,569 thousand in the same period of 2022, representing a reduction of approximately 42%[161]. - Basic and diluted loss per share for the six months ended June 30, 2023, was RMB 0.167, compared to RMB 0.307 for the same period in 2022[161]. - Other income increased significantly to RMB 25,843 thousand in the first half of 2023, compared to RMB 5,808 thousand in the same period of 2022, marking an increase of approximately 345%[156]. Cost Management - Research and development expenses decreased from RMB 266.6 million for the six months ended June 30, 2022, to RMB 186.8 million, a reduction of RMB 79.8 million[5]. - Administrative expenses decreased from RMB 134.8 million to RMB 89.2 million, a reduction of RMB 45.6 million, primarily due to lower employee costs[5]. - Sales and marketing expenses decreased from RMB 146.4 million to RMB 131.4 million, a reduction of RMB 15.0 million, mainly attributed to lower employee costs and professional fees[5]. - The adjusted loss for the six months ended June 30, 2023, was RMB 183.0 million, reflecting ongoing investments in research and development[57]. - Employee costs within R&D dropped from RMB 127.7 million to RMB 46.5 million, a decrease of about 64.5%[60]. Research and Development - The company continues to focus on reducing costs while maintaining its research and development efforts[5]. - Non-IFRS research and development expenses, excluding share-based payment expenses, decreased from RMB 218.9 million to RMB 198.1 million, a reduction of RMB 20.8 million[6]. - The company is conducting over ten discovery phase projects, including multi-specific antibodies and antibody-drug conjugates, with three treatment modalities achieving proof of concept[7]. - The company is committed to advancing its research and development strategies, particularly in immuno-oncology and personalized cancer vaccines[90]. Product Development and Regulatory Approvals - Two NDAs for Pralsetinib were approved, expanding its application in mainland China for first-line treatment of RET fusion-positive NSCLC and in Taiwan for RET fusion-positive NSCLC, RET mutation MTC, and RET fusion-positive TC[7]. - The company has received NDA approvals for Pralsetinib for treating locally advanced or metastatic RET fusion-positive NSCLC and RET mutation MTC in Taiwan and China[21]. - The company is collaborating with Pfizer to advance the commercialization of Sugliant (CS1001) in mainland China, which has been upgraded to a level 1 recommendation in the CSCO guidelines[15]. - The company has established partnerships with leading gene sequencing companies to enhance detection rates for RET mutations in NSCLC and other cancers, covering approximately 1,200 patients since the project's initiation[11]. Market Expansion and Sales Strategy - The sales coverage for precision medicine drugs has expanded from 800 hospitals in 2022 to approximately 850 hospitals across over 180 cities, covering about 75% to 80% of the relevant market[10]. - The company aims to enhance market coverage and commercial potential through digital platforms and collaborations with diagnostic companies and patient platforms[29]. - The company is focused on expanding its market presence in Asia, targeting a 15% increase in market share by the end of 2024[200]. - The company is considering potential acquisitions to bolster its product portfolio and enhance competitive positioning in the market[136]. Leadership and Governance - Dr. Li Wei has been the chairman of the board since May 31, 2022, and has over 20 years of experience in the biotechnology industry[28]. - The company has a strong board with members having extensive experience in investment and corporate governance, enhancing strategic decision-making capabilities[83]. - The leadership team is focused on enhancing operational efficiency and financial performance through strategic oversight and governance[87]. - The company has a diverse leadership team with educational backgrounds from prestigious institutions, contributing to its competitive edge[80]. Financial Position and Funding - As of June 30, 2023, the company's cash and cash equivalents and time deposits amounted to RMB 1,005.4 million, a decrease from RMB 1,042.1 million as of December 31, 2022, primarily due to R&D expenditures[70][72]. - The company raised approximately RMB 338.12 million from a placement of 84,800,000 shares at a price of HKD 4.633 per share, completed on February 15, 2023[69]. - The company obtained new bank loans of RMB 50 million in 2023 for operational funding, following previous loans of RMB 100 million in 2022 and RMB 175 million and RMB 25 million in 2020[74]. - The company has no significant investments or acquisitions as of June 30, 2023, and has no specific future plans for major investments or acquisitions[72]. Stock Incentive Plans - The company has adopted three share incentive plans, with the first plan established prior to the IPO and revised multiple times since 2017[118]. - The stock options granted are subject to performance results and other requirements outlined in the grant letter[122]. - The purpose of the stock incentive plan is to attract, motivate, and reward eligible participants for their contributions to the company[131]. - The company plans to allocate 25% of the stock options on the first anniversary of the grant date, with the remaining options vesting monthly over the following 36 months[122].

Financial Performance - Total revenue for the six months ended June 30, 2023, was RMB 261.5 million, an increase of RMB 85.5 million or 53% compared to RMB 161.4 million for the same period in 2022[3]. - Revenue from pharmaceutical sales for the six months ended June 30, 2023, was RMB 246,855,000, an increase from RMB 161,400,000 in the same period of 2022, representing a growth of 52.9%[70]. - Total revenue for the six months ended June 30, 2023, was RMB 261,474,000, slightly down from RMB 261,765,000 in the same period of 2022, indicating a decrease of 0.11%[70]. - Gross profit for the same period was RMB 153,437 thousand, down from RMB 169,042 thousand, reflecting a decline of approximately 9.25%[60]. - The net loss for the six months ended June 30, 2023, was RMB 209,226,000, compared to a net loss of RMB 361,569,000 in the same period of 2022, showing an improvement of 42.1%[77]. - Basic and diluted loss per share for the six months ended June 30, 2023, was RMB 0.167, compared to RMB 0.307 for the same period in 2022, indicating a reduction in loss per share[77]. - The adjusted loss for the six months ended June 30, 2023, was RMB (183,038) thousand, compared to RMB (257,083) thousand for the same period in 2022, representing a 29% improvement[89]. Expenses Management - Research and development expenses decreased from RMB 266.6 million for the six months ended June 30, 2022, to RMB 186.8 million, a reduction of RMB 79.8 million[3]. - Administrative expenses decreased from RMB 134.8 million for the six months ended June 30, 2022, to RMB 89.2 million, a reduction of RMB 45.6 million[4]. - Sales and marketing expenses decreased from RMB 146.4 million for the six months ended June 30, 2022, to RMB 131.4 million, a reduction of RMB 15 million[4]. - The company’s total employee costs for the six months ended June 30, 2023, amounted to RMB 135,391,000, down from RMB 269,803,000 in the same period of 2022, a decrease of 49.8%[75]. - Research and development expenses for the six months ended June 30, 2023, were RMB (198,147) thousand, down from RMB (218,874) thousand in 2022, indicating a 9.5% decrease[90]. - Administrative, sales, and marketing expenses adjusted for the six months ended June 30, 2023, were RMB (183,069) thousand, compared to RMB (224,437) thousand in 2022, reflecting an 18.4% reduction[91]. Product Development and Approvals - The company achieved two NDA approvals for Pralsetinib, expanding its application in first-line treatment for RET fusion-positive NSCLC in mainland China and Taiwan[5]. - Five NDAs are currently under review, including Suglitinib for various cancer indications in mainland China and the EU[5]. - The CS5001 international multi-center clinical trial has expanded to China, showing good safety and tolerability in initial human trials[5]. - The company has over ten discovery phase projects, including multi-specific antibodies and proprietary cell-penetrating therapies[5]. - The NDA for Sugli monoclonal antibody for first-line treatment of advanced or metastatic GC/GEJ patients was accepted by the National Medical Products Administration in February 2023[19]. - The NDA for Pralsetinib for treating locally advanced or metastatic RET fusion-positive NSCLC was approved by the Taiwan Food and Drug Administration in January 2023[21]. - The NDA for avapritinib (CS3007) for the treatment of adult indolent systemic mastocytosis was approved by the FDA in May 2023[24]. - The company aims to obtain NDA approval for sugliolimab in China for R/R ENKTL by the end of 2023[31]. - The company plans to submit MAA applications for sugliolimab in the EU and the UK for first-line treatment of IV stage NSCLC in the first half of 2024[31]. Market Expansion and Accessibility - The sales of marketed products, including Pralsetinib, Alectinib, and Avapritinib, reached RMB 246.9 million in the first half of 2023[7]. - The sales coverage of precision therapy drugs has expanded from 800 hospitals in 2022 to approximately 850 hospitals across over 180 cities, covering about 75% to 80% of the relevant market[9]. - The company has established strategic partnerships to expand the distribution of its drugs across major commercial and government insurance plans, covering a population of approximately 100 million[14]. - Pralsetinib is included in 138 commercial and government insurance plans, enhancing its accessibility and affordability[38]. - The company has updated its pricing strategy to improve accessibility and affordability, including lowering thresholds for patient assistance programs for Pralsetinib and Avapritinib[13]. - Approximately 300 hospitals and direct-to-patient pharmacies have listed Avapritinib, Pralsetinib, and Avapritinib, an increase from about 220 hospitals in 2022[14]. - The online patient community has over 8,000 subscribers, with more than 330 patient stories published and around 200 educational events held, reaching 20,000 potential patients[15]. Collaborations and Partnerships - The company is collaborating with Pfizer to commercialize Sugli monoclonal antibody in mainland China, which has been upgraded to a level 1 recommendation in multiple treatment guidelines[16]. - The company is collaborating with Pfizer to develop lorlatinib for ROS1-positive advanced NSCLC patients, with patient enrollment completed in June 2023[25]. - The strategic partnership with Pfizer has led to the approval of the first indication for sugemalimab in December 2021, with a second indication approved in May 2022[54]. - Ongoing collaboration with Duality Biologics is expected to yield multiple bispecific and trispecific molecules in the trial phase, with sequence handover anticipated in the second half of 2023[58]. Financial Position and Stability - Cash and cash equivalents increased to RMB 906,224 thousand from RMB 558,684 thousand, representing a growth of about 62.3%[61]. - Accounts receivable rose significantly to RMB 185,867 thousand from RMB 77,133 thousand, an increase of approximately 141%[61]. - Total assets decreased slightly to RMB 1,234,195 thousand from RMB 1,246,917 thousand, a decline of about 1%[61]. - The company's equity increased to RMB 603,715 thousand from RMB 449,326 thousand, reflecting a growth of approximately 34.3%[63]. - The debt-to-asset ratio as of June 30, 2023, was 63.6%, down from 72.6% as of December 31, 2022, indicating improved financial stability[95]. - The company raised approximately $200 million (equivalent to about RMB 1,355.9 million) from the subscription agreement with Pfizer, which will be used for development activities under the collaboration agreement[104]. Corporate Governance and Compliance - The audit committee consists of three independent non-executive directors, ensuring compliance with corporate governance standards[108]. - The company has adhered to all corporate governance codes as per the listing rules during the reporting period[100]. - The company has not been involved in any significant litigation or arbitration during the reporting period[102].

Financial Performance - Revenue increased from RMB 243.7 million in 2021 to RMB 481.4 million in 2022, a growth of 97.5%[7] - Pharmaceutical sales contributed RMB 364.3 million, while licensing income was RMB 87.3 million and royalties from Sugli monoclonal antibody amounted to RMB 29.8 million[7] - Net loss decreased from RMB 1,920.1 million in 2021 to RMB 902.7 million in 2022, a reduction of 52.9%[7] - Total revenue reached RMB 481.4 million, with commercial revenue of RMB 394.1 million, including precision therapy drug sales of RMB 364.3 million and licensing income from Shugli monoclonal antibody of RMB 29.8 million[10] - The company reported a net loss of RMB 902.7 million, compared to a net loss of RMB 1,920.1 million in the previous year[9] - The company achieved a total net sales of RMB 364.3 million in 2022, driven by stable growth of Tai Ji Hua® (Apatinib) and Pu Ji Hua® (Pralsetinib) and robust sales growth of Tuo Shu Wo® (Ivosidenib) [34] - The company achieved a commercial revenue growth of 142% year-on-year, nearly doubling total revenue by year-end[30] Research and Development - R&D expenses decreased from RMB 1,304.9 million in 2021 to RMB 614.2 million in 2022, a reduction of 53%[7] - R&D expenses, excluding share-based payment costs, decreased from RMB 1,182.1 million in 2021 to RMB 559.1 million in 2022, a drop of 47.3%[8] - The company conducted over ten discovery phase projects, including bispecific antibodies and proprietary platforms for treating refractory intracellular targets[10] - The company is actively expanding its pipeline and market presence through strategic collaborations and regulatory submissions across multiple regions[20] - The company has a robust pipeline consisting of 15 tumor candidate drugs, focusing on precision therapy and immunotherapy[32] - The company is conducting Phase I clinical trials for the potential global best-in-class drug CS5001 (ROR1-targeted ADC) in the US, Australia, and mainland China, with preliminary data expected by year-end[30] Product Development and Approvals - Two new products successfully launched: Shugli monoclonal antibody and Avapritinib, bringing the total number of commercialized products to four[10] - Three products received five NDA approvals, including Shugli monoclonal antibody for NSCLC and Avapritinib for R/R AML in mainland China[10] - Six additional NDAs are currently under review, including Shugli monoclonal antibody for multiple indications in mainland China and Europe[10] - The company has received five NDA approvals and submitted eight NDA applications, enhancing its diverse pipeline of marketed and near-commercialized drugs[19] - Sugli monoclonal antibody (CS1001) became the first PD-1/PD-L1 monoclonal antibody approved in China for treating unresectable stage III NSCLC patients, with NDA approval granted in May 2022[19] Strategic Initiatives - The company aims to continue expanding its product portfolio and market presence in the coming years[7] - Strategic initiatives include potential mergers and acquisitions to enhance growth opportunities[7] - The company is collaborating closely with Pfizer to advance the commercialization of Shugulizumab in mainland China, with all commercial agreements signed for market preparation[18] - The company has established partnerships with pharmaceutical and biotech companies to enhance its global vision and commercial plans[34] Market Expansion and Accessibility - The coverage of the sales team expanded from 600 hospitals in 2021 to approximately 800 hospitals across over 180 cities, capturing about 75% to 80% of the precision medicine market [12] - The company updated its pricing strategy for listed products, ensuring inclusion in 130 major commercial and government insurance plans, covering over 90 million people, an increase from over 60 million in 2021 [15] - The company has signed cooperation agreements with leading gene sequencing companies to enhance detection rates for RET mutations in NSCLC/TC and other conditions, reaching over 5,000 pathologists and clinicians through educational activities [12] - The company has made significant progress in enhancing the accessibility and affordability of Tazverik (Avapritinib), which is now included in 80 commercial and government insurance plans[39] Financial Management and Risks - Cash and cash equivalents totaled RMB 1,042.1 million, down from RMB 1,603.4 million in the previous year[9] - Total assets decreased to RMB 1,638.4 million from RMB 2,271.5 million in the previous year[9] - Total liabilities increased to RMB 1,189.1 million from RMB 1,064.4 million in the previous year[9] - The company has incurred significant net losses and operating cash outflows since its inception, with expectations to continue this trend in the foreseeable future[95] - The company may require additional funding to meet operational cash needs, which may not be obtainable on acceptable terms[95] - The company faces risks related to the commercialization of its drugs, including potential delays in obtaining regulatory approvals, which could significantly harm its revenue-generating capabilities[99] Corporate Governance - The company has established five board committees, including the audit committee, to oversee specific areas of governance and ensure effective management[166] - The board consists of eight members, including one executive director, four non-executive directors, and three independent non-executive directors[173] - The company emphasizes the importance of ongoing professional development for directors and senior management to maintain governance standards[189] - The company has mechanisms in place to manage conflicts of interest, ensuring that directors with significant interests do not vote on related resolutions[180] Leadership and Management - The company appointed Dr. Yang Jianxin as CEO starting August 25, 2022, who has been with the company as Senior Vice President and Chief Medical Officer since December 2016[85] - The management team includes experienced professionals with backgrounds in major pharmaceutical companies and consulting firms, enhancing the company's strategic capabilities[85][87] - The company is committed to expanding its market presence and enhancing its product pipeline through strategic leadership and innovative research[86] Employee and Shareholder Engagement - The company has established an employee stock ownership plan post-IPO, with a maximum allocation of shares not exceeding 10% of the total shares issued under the plan[143] - The company aims to attract and retain employees through its employee stock ownership plan and restricted share award plan[140] - The company expresses gratitude to its stakeholders, including researchers, patients, and shareholders, for their trust and support[30]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 CStone Pharmaceuticals 基石藥業 （於開曼群島註冊成立的有限公司） （股份代號：2616） 截至二零二二年十二月三十一日止年度 年度業績公告 基石藥業（「本公司」或「基石藥業」）董事（「董事」）會（「董事會」）欣然宣佈，本公 司及其附屬公司（統稱「本集團」或「我們」）截至二零二二年十二月三十一日止年度 （「報告期間」）的經審核綜合業績，連同截至二零二一年十二月三十一日止年度的 比較數字。除文義另有所指外，本公告所用詞彙與本公司日期為二零一九年二月 十四日的招股章程（「招股章程」）以及日期為二零二二年五月三十一日的截至二零 二一年十二月三十一日止年度之年度業績公告所界定者具有相同涵義。 財務摘要 國際財務報告準則（「國際財務報告準則」）計量： • 收入由截至二零二一年十二月三十一日止年度的人民幣243.7百萬元增加人民 幣237.7百萬元至截至二零二二年十二月三十一日止年度的人民幣4 ...

CStone Pharmaceuticals 基石藥業 (Incorporated in the Cayman Islands with limited liability) ( 於開曼群島註冊成立的有限公司 ) Stock Code 股份代號 : 2616 年度報告 2021 Annual Report 目錄 | | 頁次 | | 頁次 | | --- | --- | --- | --- | | 公司資料 | 2 | 綜合損益及其他全面收益表 | 106 | | 財務摘要 | 4 | 綜合財務狀況表 | 107 | | 業務摘要 | 6 | 綜合權益變動表 | 109 | | 主席致辭 | 20 | 綜合現金流量表 | 111 | | 管理層討論及分析 | 21 | 綜合財務報表附註 | 113 | | 董事及高級管理層 | 41 | 釋義 | 182 | | 董事會報告 | 51 | | | | 企業管治報告 | 80 | | | | 獨立核數師報告 | 101 | | | 公司資料 董事會 執行董事 江寧軍博士(1) （首席執行官） 非執行董事 李偉博士(2) （主席） Kenneth Walton H ...