本次sBLA是基于一项将倍诺达®用于一线治疗失败后不适合自体干细胞移植的成人r/rLBCL的单臂、多 中心、关键性临床研究的结果。这项在中国开展的2期单臂开放研究纳入了接受过靶向CD20抗体和蒽环 类一线系统治疗失败的且不适合ASCT的r/r LBCL患者。患者在清淋化疗后接受了100×106CAR+T细 胞。截至2025年1月21日，已完成49例患者的回输并完成了至少3个月的随访；基于48例可进行疗效评估 的患者，瑞基奥仑赛展现了显着的临床疗效和良好的安全性，最佳客观缓解率(ORR)为81.3%，最佳完 全缓解率(CRR)为54.2%，重度(≥3级)的细胞因数释放综合征(CRS)发生率为4.1%，无重度神经毒性(NT) 发生。 格隆汇5月28日丨药明巨诺-B(02126.HK)宣布中国国家药品监督管理局("NMPA")已受理其细胞免疫治疗 产品倍诺达®(瑞基奥仑赛注射液)用于二线治疗复发或难治成人大B细胞淋巴瘤("r/r LBCL")患者的新适 应症上市许可申请("sBLA")。这是药明巨诺针对倍诺达®递交的第四项上市许可申请。于2025年1月， 倍诺达®被NMPA授予二线治疗r/r LBCL的突破性治疗药 ...

Financial Performance - In 2024, JW Therapeutics generated nearly RMB 160 million in revenue from the sales of Benaodai®, maintaining stability compared to 2023[9]. - Revenue for the year ended December 31, 2024, was RMB 158.2 million, a decrease of 9.0% from RMB 173.9 million for the year ended December 31, 2023[13]. - Gross profit decreased by 12.4% to RMB 77.3 million, with a gross margin of 48.9%, down from 50.7% in the previous year[14]. - The net loss for the year ended December 31, 2024, was RMB 590.6 million, a reduction from RMB 768.0 million in the previous year[15]. - The adjusted loss for the year ended December 31, 2024, decreased to RMB 405.5 million from RMB 514.5 million for the year ended December 31, 2023, primarily due to reduced general and administrative expenses[19]. - Other income and losses decreased to RMB 147.6 million from RMB 219.2 million, reflecting a reduction in impairment losses related to licenses[15]. - Total assets decreased to RMB 1,680.4 million as of December 31, 2024, down from RMB 2,146.1 million in the previous year[17]. - As of December 31, 2024, cash and cash equivalents amounted to RMB 757.4 million, a decrease of RMB 248.5 million compared to RMB 1,005.9 million as of December 31, 2023[18]. - The company had a cash outflow of RMB 248.5 million during the year, primarily due to R&D expenses and administrative costs[87]. - The total number of employees decreased by 29.4% to 281 as of December 31, 2024, compared to 398 in 2023[98]. Research and Development - The company initiated a Phase I clinical trial for relma-cel in treating SLE, with patient enrollment completed by the end of 2024[10]. - The company aims to continue the development of Beiduo Da® for treating other hematological malignancies and autoimmune diseases, with a new drug application submission planned[12]. - The company has made significant progress in developing innovative products with global commercialization potential[22]. - The company is focused on expanding its pipeline of CAR T-cell therapies targeting various hematological malignancies and autoimmune diseases[40]. - The company has initiated clinical development for cell therapy products targeting MAGE-A4 and DLL3 for solid tumors, and started IND research for relma-cel as a potential treatment for SLE[36]. - The company is developing a targeted therapy for SLE, which is anticipated to capture a significant market share due to the high treatment demand[55]. - JWTCR001, a specific cell therapy product targeting MAGE-A4, has received priority review from the FDA for its application in treating synovial sarcoma[57]. - The company is advancing multiple candidates for solid tumors, with ongoing clinical trials for products targeting HCC and other malignancies[56]. Product Development and Approval - Benaodai® received approval from the National Medical Products Administration in August 2024 for the treatment of r/r MCL patients, becoming the first cell therapy product approved in China for this indication[10]. - The National Medical Products Administration accepted the supplemental new drug application for Benauda to treat r/r MCL adult patients in early 2024, with priority review granted[36]. - The company plans to submit a new drug application for Beinuoda® for the treatment of r/r MCL patients in the first half of 2025, following the completion of patient enrollment in the clinical trial[27]. - Relma-cel has received breakthrough therapy designation for second-line treatment of r/r LBCL, with the first patient enrolled in November 2023 and completion of enrollment expected in H2 2024[44]. Market Strategy and Expansion - JW Therapeutics is focusing on three main areas for progress in 2025, aiming to lead the development of high-quality cell immunotherapy products in China and globally[11]. - The company is actively seeking business collaboration opportunities with domestic and international partners to enhance clinical development efficiency and generate positive cash flow[12]. - The company is focusing on international expansion and developing innovative pipeline products targeting blood cancers, solid tumors, and autoimmune diseases[28]. - The commercial team has been strengthened to enhance the commercialization of Benauda in China, focusing on training healthcare professionals and expanding insurance coverage[34]. Cost Management and Efficiency - Research and development expenses decreased by 31.6% to RMB 283.0 million, primarily due to optimization of R&D personnel and reduced employee benefits expenses[14]. - Sales expenses increased by 24.0% to RMB 140.4 million, driven by exploration of various commercialization methods[14]. - The company has implemented a cost reduction plan, including sourcing key raw materials from domestic suppliers, to enhance efficiency and control costs[29][35]. - The company has streamlined its organization to enhance sales revenue growth and operational efficiency[22]. Leadership and Governance - Liu Min was appointed as the CEO and Executive Director of the company on July 31, 2024, bringing over 25 years of experience in the pharmaceutical industry[113]. - The company has a strong leadership team with diverse backgrounds in the biopharmaceutical sector, including experience from major firms like Roche and Merck[115][118]. - The company has established a robust governance structure with independent directors providing oversight and strategic advice[120]. - The company is committed to regulatory compliance and effective corporate governance to support its growth initiatives[113]. Challenges and Risks - The company has incurred significant losses since its inception and expects to continue experiencing losses in the foreseeable future[137]. - The lengthy and costly clinical development process for biopharmaceutical products is fraught with uncertainty, and early research results may not predict future trial outcomes[137]. - Regulatory approval processes for candidate products are lengthy, time-consuming, and unpredictable, which could severely impact the company's business if approvals are delayed or not obtained[140]. - The company may face difficulties in production processes, especially in developing or scaling up production capacity for its cell therapy products[140]. Employee and Compensation - Total payroll costs for the year were RMB 227.7 million, down from RMB 323.6 million in the previous year, representing a 29.6% reduction[98]. - The employee distribution by function as of December 31, 2024, is as follows: Production 41.3%, R&D 25.3%, Commercial 17.4%, and Support Functions 12.8%[173]. - The company has adopted various incentive plans, including pre-IPO and post-IPO incentive plans[174].

截至2024年12月31日止年度，作为一家专注于开发、生产及商业化细胞免疫治疗产品的独立的创新型生 物科技公司，我们的业务取得进一步重大进展，并实现重要里程碑，运营效率全面提升，例如毛利率维 持稳定、扩展营销活动并有效控制销售开支、组织精简、现金流出净额减少等。我们的领先产品倍诺达 ® 在商业化方面持续取得进展。此外，凭藉卓越的临床开发及运营能力，中国国家药品监督管理局(国 家药监局)已批准有关倍诺达®用于不符合移植条件的 r/r LBCL患者的二线治疗的临床研究用新药(IND) 申请，且我们已开展相关临床试验的患者入组。国家药监局已进一步批准倍诺达®治疗r/r套细胞淋巴瘤 (MCL)患者的补充新药申请(补充新药申请)。倍诺达®成为首个在中国批准用于治疗r/r MCL患者的细胞 治疗产品。此外，我们在研发具有全球商业化潜力的创新产品方面取得了重大进展。 2024年下半年，我们的商业团队在人员与架构方面均进行了调整。目前，我们已建立强劲的商业团队， 负责倍诺达®在中国的商业化。我们的商业团队具备强大的商业化能力，涵盖销售团队、市场团队、市 场准入及创新支付团队以及 CAR-T顾问团队。 智通财经APP讯，药明巨 ...

Financial Performance - Revenue for the year ended December 31, 2024, was RMB 158.2 million, a decrease of 9.0% from RMB 173.9 million for the year ended December 31, 2023[3]. - Gross profit decreased by 12.4% to RMB 77.3 million, with a gross margin of 48.9%, down from 50.7% in the previous year[3]. - Net loss for the year ended December 31, 2024, was RMB 590.6 million, down from RMB 768.0 million in the previous year[5]. - Adjusted loss for the year ended December 31, 2024, was RMB 405.5 million, a decrease of RMB 109.0 million from RMB 514.5 million in the previous year[6]. - The company's annual loss for the year ended December 31, 2024, was RMB 590.6 million, a decrease of 23.2% from RMB 768.0 million for the year ended December 31, 2023[70]. - Other income for the year ended December 31, 2024, was RMB 6.9 million, down from RMB 8.2 million in 2023, primarily related to government subsidies[66]. - The net foreign exchange loss decreased from RMB 37.3 million in 2023 to RMB 15.6 million in 2024, attributed to a milder depreciation of the RMB against the USD and HKD[70]. - The total assets decreased from RMB 2,146.1 million in 2023 to RMB 1,680.4 million in 2024, while total liabilities increased from RMB 462.3 million to RMB 511.2 million[73]. - Cash and cash equivalents as of December 31, 2024, were RMB 757.4 million, compared to RMB 1,005.9 million as of December 31, 2023[5]. - The current ratio decreased from 4.0 in 2023 to 1.7 in 2024, indicating a tighter liquidity position[76]. Research and Development - Research and development expenses decreased by 31.6% to RMB 283.0 million, mainly due to optimization of R&D personnel and reduced employee benefits[4]. - The company has initiated clinical development for cell therapy products targeting melanoma-associated antigen A4 (MAGE-A4) and Delta-like canonical Notch ligand 3 (DLL3) in the first half of 2024[13]. - The company is exploring innovative methods to simplify production processes through non-viral approaches and existing CAR products[14]. - The company continues to develop other pipeline products, including JWCAR201, a dual-targeting CAR T cell therapy for B-cell malignancies and autoimmune diseases, with patient recruitment ongoing throughout 2024[23]. - The company has established a differentiated pipeline in cell immunotherapy, with opportunities to expand into emerging solid tumors and autoimmune disease cell therapies[22]. Commercialization and Product Development - The company achieved significant milestones in commercialization, including the approval of clinical trials for its leading product, Benauda®[7]. - Benauda® became the first cell therapy product approved in China for the treatment of r/r MCL patients[7]. - As of December 31, 2024, the product Beinuoda® has been included in over 80 commercial insurance products and 102 local government supplementary medical insurance plans[12]. - The company plans to submit a new drug application for Beinuoda® for r/r LBCL patients in the first half of 2025, following the completion of patient enrollment in a Phase II registration clinical trial in the second half of 2024[12]. - The company has adjusted its commercial team structure to enhance the commercialization of Beinuoda® in China[19]. - The company is focused on developing therapies that may provide a first-mover advantage in promising markets through its innovative product pipeline[22]. Cost Management and Efficiency - Sales expenses increased by 24.0% to RMB 140.4 million, primarily due to exploration of various commercialization methods[4]. - The company continued to execute cost reduction plans, stabilizing gross margin at 48.9% for the year[8]. - The company has made significant progress in its cost reduction strategy initiated in 2020, successfully completing the short-term plan in 2022 and starting the mid-term plan to source key raw materials from domestic suppliers by December 31, 2024[20]. - The company is focused on enhancing production capacity and implementing cost reduction plans through innovation and economies of scale[52]. Regulatory and Compliance - The NMPA granted breakthrough therapy designation and priority review for Beinuoda® for the treatment of r/r MCL, highlighting its potential in the market[22]. - The company submitted a new IND application for Breyanzi as a second-line treatment for r/r LBCL patients in January 2023, with the first patient enrolled in November 2023 and expected completion of enrollment by mid-2024[30]. - The National Medical Products Administration (NMPA) granted breakthrough therapy designation for Breyanzi, with the primary endpoint of the study achieved, and a new drug application planned for submission in the first half of 2025[30]. - The company has adopted the corporate governance code and has complied with its provisions throughout the year ending December 31, 2024[125]. - The board has established an audit committee to monitor compliance with applicable laws and regulations, ensuring effective internal controls and risk management[131]. Employee and Operational Changes - The total number of employees as of December 31, 2024, was 281, a reduction of 29.4% from 398 employees as of December 31, 2023[85]. - Total employee costs, including director remuneration, decreased to RMB 227,696 thousand in 2024 from RMB 323,620 thousand in 2023, a reduction of about 30%[100]. - The company is currently negotiating loan terms with banks due to non-compliance with loan covenants as of December 31, 2024[75].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 86.8 million, relatively stable compared to RMB 87.7 million for the same period in 2023[19]. - Gross profit for the same period was RMB 43.7 million, down from RMB 44.8 million in 2023, indicating a slight decrease in profitability[19]. - The company reported a net loss before tax of RMB 240.3 million, compared to RMB 380.4 million in the previous year, indicating a significant reduction in losses[19]. - Total comprehensive loss for the period was RMB 220.7 million, compared to RMB 245.8 million in 2023, showing an overall improvement[19]. - Adjusted loss for the period was RMB 214.7 million, down from RMB 267.1 million year-over-year, indicating a positive trend in financial performance[19]. - The net loss for the six months ended June 30, 2024, was RMB 240.3 million, down from RMB 380.4 million in the same period of 2023, driven by improved operational efficiency and reduced R&D expenses[20]. - The company reported a basic and diluted loss per share of RMB 0.58, an improvement from RMB 0.93 in the previous year[131]. - The company reported a loss attributable to ordinary shareholders of RMB 240,267 thousand, compared to a loss of RMB 380,415 thousand, representing an improvement of approximately 36.9%[156]. Research and Development - Research and development expenses decreased to RMB 151.0 million from RMB 216.5 million year-over-year, reflecting a 30.3% reduction[19]. - Research and development expenses decreased by 30.3% to RMB 151 million for the six months ended June 30, 2024, from RMB 216.5 million in the same period of 2023, due to improved operational efficiency and optimized R&D strategies[20]. - The company is developing two dual-targeted autologous CAR T-cell therapies to enhance treatment efficacy for autoimmune diseases and B-cell malignancies[28]. - The company has initiated clinical trials for Relma-cel in treating moderate to severe active SLE patients, with IND approval obtained in April 2023[33]. - The company is focusing on building its own capabilities for the sustainable supply of key materials, such as lentiviral vectors, to support production[60]. - The company continues to focus on research and development, with ongoing projects in CAR-T technology, although specific financial allocations were not disclosed in the provided documents[194]. Product Development and Commercialization - The targeted CD19 CAR-T immunotherapy product, Relma-cel, continues to be commercialized, approved for treating adult patients with relapsed or refractory large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma[19]. - The company achieved significant milestones in commercialization, with the leading product, Benauda®, included in 78 commercial insurance products and 96 local government supplementary medical insurance plans as of June 30, 2024[23]. - The National Medical Products Administration approved Benauda® for clinical trials in treating r/r LBCL patients, marking a significant advancement in the company's product pipeline[23]. - The company has made significant progress in developing its lead product, Relma-cel, for the treatment of hematological malignancies, with a supplemental new drug application approved by the National Medical Products Administration in August 2024 for r/r MCL adult patients[33]. - The company is expanding its product pipeline with new candidates targeting emerging solid tumors and autoimmune diseases, including MAGE-A4 and DLL3[33]. - The company plans to continue the commercialization of its product, Relma-cel, and expand its clinical development in autoimmune diseases[61]. Operational Efficiency - Operating loss narrowed to RMB 247.5 million from RMB 389.9 million, showing an improvement in operational efficiency[19]. - General and administrative expenses decreased by 24.7% to RMB 592 million for the six months ended June 30, 2024, from RMB 787 million in the same period of 2023, attributed to operational excellence initiatives[20]. - The company has made significant progress in its cost reduction strategy, including sourcing key raw materials from domestic suppliers as of June 30, 2024[32]. - The company aims to enhance production capacity and implement cost reduction plans through innovation and economies of scale[61]. - The company is actively communicating with regulatory authorities to apply for further capacity increases to meet growing demand[60]. Market and Expansion - The company is focusing on international expansion with new pipeline products targeting blood cancers, solid tumors, and autoimmune diseases, incorporating internal design modifications to enhance CAR therapy efficacy and durability[28]. - In the first half of 2024, sales of CAR-T products in China remained relatively stable compared to the same period in 2023, with strong growth expected in the CAR-T treatment market until 2030[30]. - The company is exploring market expansion opportunities, particularly in the Asia-Pacific region, to enhance its competitive position[194]. Financial Position - Cash and cash equivalents as of June 30, 2024, were RMB 869 million, compared to RMB 110.4 million as of June 30, 2023, with a net cash outflow of RMB 136.9 million during the period[20]. - Total current assets as of June 30, 2024, were RMB 944.37 million, compared to RMB 1,067.48 million as of December 31, 2023[77]. - Total liabilities increased from RMB 462.26 million as of December 31, 2023, to RMB 497.88 million as of June 30, 2024[77]. - The current ratio decreased from 4.0 as of December 31, 2023, to 2.9 as of June 30, 2024[80]. - The total debt to total assets ratio increased from 0.2 as of December 31, 2023, to 0.3 as of June 30, 2024[80]. Governance and Compliance - The company has adopted corporate governance practices in compliance with relevant codes and regulations[90]. - The company has appointed a new CEO and made several changes to its board of directors, effective July 31, 2024[103]. - The company has not been involved in any significant litigation or arbitration as of June 30, 2024, and there are no pending or potential significant lawsuits known to the directors[129]. Risks and Challenges - The company continues to face significant financial risks, including ongoing losses since inception and potential impairment of intangible assets[95]. - The clinical development process for biopharmaceutical products is lengthy and costly, with uncertain outcomes that may lead to additional costs or delays in product commercialization[97]. - Regulatory approval processes for biopharmaceutical products are lengthy and unpredictable, and failure to obtain timely approvals could severely damage the company's business[98]. - The company faces significant risks related to international trade policies and ongoing tensions between the US and China, which may adversely impact its business and expansion plans[96].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 868 million, relatively stable compared to RMB 877 million for the same period in 2023[2]. - Gross profit for the same period was RMB 437 million, slightly decreasing from RMB 448 million, with a gross margin of 50.4%, down from 51.1%[3]. - Net loss for the period was RMB 240.3 million, down from RMB 380.4 million, primarily due to improved operational efficiency and reduced expenses[3]. - Adjusted loss decreased to RMB 214.7 million from RMB 267.1 million, reflecting improved operational efficiency and reduced expenses[4]. - Financial income for the six months ended June 30, 2024, was RMB 13.3 million, compared to RMB 9.5 million in the previous period[38]. - The net loss for the six months ended June 30, 2024, was RMB 2,402.67 million, down from RMB 3,804.15 million for the same period in 2023, attributed to improved operational efficiency and reduced administrative expenses[49]. - Basic loss per share improved to RMB 0.58 for the six months ended June 30, 2024, compared to RMB 0.93 for the same period in 2023, indicating a reduction in losses[79]. Expenses and Cost Management - Research and development expenses decreased by 30.3% to RMB 151 million from RMB 216.5 million, attributed to improved operational efficiency and optimized R&D strategies[3]. - Sales expenses increased by 26.6% to RMB 762 million from RMB 602 million, driven by market expansion activities and sales strategy optimization[3]. - General and administrative expenses decreased by 24.7% to RMB 592 million from RMB 787 million, due to enhanced operational excellence[3]. - The company has made significant progress in reducing manufacturing costs, including optimizing raw material usage and transitioning to domestic suppliers, which is expected to further lower costs in the coming years[11]. Product Development and Clinical Trials - The company received regulatory approval for clinical trials of its lead product, Relma-cel, for second-line treatment of r/r LBCL patients[4]. - Significant progress was made in developing innovative products with global commercialization potential, including the initiation of a trial for JWATM 214 for advanced HCC[4]. - The company is developing two dual-targeted autologous CAR T cell therapies to enhance efficacy and performance in treating autoimmune diseases and B-cell malignancies[6]. - Clinical trials for Benodda® as a second-line treatment for large B-cell lymphoma (LBCL) are actively recruiting patients, with completion expected by the end of 2024[12]. - The company has expanded its product pipeline to include treatments for solid tumors and autoimmune diseases, with ongoing clinical research for relma-cel in systemic lupus erythematosus (SLE)[12]. Regulatory Approvals and Market Expansion - The National Medical Products Administration approved the supplemental new drug application for Beiduo in August 2024 for treating adult patients with r/r MCL after two or more systemic therapies[5]. - The National Medical Products Administration approved the supplemental new drug application for Benodda® for treating adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL) in August 2024[12]. - The company has expanded its collaboration with 2seventy bio, Inc. for the co-development and commercialization of CAR-T cell products for autoimmune diseases[6]. Cash and Assets Management - Cash and cash equivalents as of June 30, 2024, were RMB 869 million, compared to RMB 110.4 million as of June 30, 2023[4]. - Total assets as of June 30, 2024, were RMB 1,979.82 million, down from RMB 2,146.10 million as of December 31, 2023[51]. - Current liabilities totaled RMB 323.43 million as of June 30, 2024, primarily consisting of borrowings of RMB 192.5 million[52]. - The company had unutilized bank loan facilities amounting to RMB 403.9 million as of June 30, 2024[52]. Corporate Governance and Compliance - The company has adopted a corporate governance code to enhance shareholder value and accountability, fully complying with relevant provisions as of June 30, 2024[92]. - The company has established an audit committee to monitor compliance with applicable laws and regulations, ensuring effective internal control and risk management[96]. - The company has a clear separation of roles between the Chairman and the CEO, enhancing governance and business outlook[93].

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 1,739 million, an increase of 19.3% compared to RMB 1,457 million for the year ended December 31, 2022, driven by the continued commercialization of the CAR-T therapy product, Relma-cel[17]. - Gross margin improved from 40.3% in 2022 to 50.7% in 2023 due to ongoing cost reduction initiatives[11]. - General and administrative expenses decreased by 22.1% from RMB 1,798 million in 2022 to RMB 1,400 million in 2023, primarily due to reductions in employee benefits and professional service fees[18]. - The adjusted loss for the year (non-IFRS) was RMB 514 million, a decrease from RMB 605 million in the previous year[24]. - The total comprehensive loss for the year was RMB 705.4 million, compared to RMB 519.2 million in the previous year, indicating a decline of 35.8%[39]. - The company reported a net loss of RMB 767,996 million for the year ended December 31, 2023, compared to a net loss of RMB 846,135 million in 2022[69]. - The adjusted loss for the year, excluding certain non-cash items and one-time events, reflects the core operating performance of the company[46]. Cash and Assets - Cash and cash equivalents as of December 31, 2023, were RMB 1,059 million, compared to RMB 451 million as of December 31, 2022, with a net cash outflow of RMB 374 million during the year[21]. - The total assets of the company decreased to RMB 2.15 billion in 2023 from RMB 2.79 billion in 2022, a decline of 22.8%[44]. Product Development and Research - The company is focused on developing new CAR-T products targeting hematological cancers, solid tumors, and autoimmune diseases, with internal design modifications to enhance efficacy and durability[12]. - The company has initiated clinical trials for relma-cel for the treatment of SLE, with promising initial safety and efficacy data observed[52]. - The company has begun sourcing key raw materials from domestic suppliers, leading to a 17.3% reduction in sales costs per batch compared to the average sales cost in 2022[60]. - The company has initiated preclinical development for cell therapy products targeting MAGE-A4 and DLL3, based on licenses obtained from 2seventy bio and Juno Therapeutics[53]. - The company is focused on optimizing production processes to enhance efficiency and reduce costs over the next 3 to 5 years[60]. - The company is developing a new product, JWATM214, for HCC treatment, with the manufacturing process fully developed in China and an IIT initiated in February 2023[152]. - JWTCR001, a specific cell therapy product targeting MAGE-A4, has shown clinical efficacy in early trials for treating solid tumors expressing MAGE-A4, with a BLA accepted by the FDA for review[153]. - The company is focusing on developing new CAR products for solid tumors, expected to be delivered for clinical use by 2025, utilizing enhanced modification elements to improve efficacy[158]. Market Expansion and Ecosystem - The company aims to expand the ecosystem for CAR-T therapies in China, increasing the number of commercial insurance products and local government supplementary medical insurance plans for patients[11]. - As of December 31, 2023, the product Beiduo Da® was included in 70 commercial insurance products and 105 local government supplementary medical insurance plans, with 51% of patients receiving insurance compensation[49]. - The company expects to benefit from the anticipated strong growth in the Chinese cell therapy market over the coming years[36]. - The CAR-T therapy market in China is expected to experience strong growth until 2030, positioning the company favorably in this expanding market[83]. Operational Efficiency - Sales expenses decreased by 40.7% to RMB 113.2 million in 2023 from RMB 190.9 million in 2022, primarily due to optimized staffing for commercial operations[41]. - The company continues to execute cost-cutting measures, resulting in reduced general and administrative expenses to RMB 140,048 million in 2023 from RMB 179,763 million in 2022[69]. - The company achieved a production success rate of 98% for its product Beinuoda® in 2023, maintaining high operational performance[34]. - The company achieved a 98% high production success rate since initiating LBCL registration clinical trials, with multiple approvals to expand production capacity in late 2022 and early 2023[143]. Strategic Collaborations and Partnerships - The company has established a strategic alliance with 2seventy bio for the development and commercialization of MAGE-A4 targeted cell therapy products in Greater China, aiming for early market entry[154]. - The company has expanded its strategic collaboration with 2seventy bio, Inc. for the co-development and commercialization of CAR-T cell products for autoimmune diseases in Greater China[115]. Clinical Trials and Efficacy - The objective response rate (ORR) for Benodada® in the Phase II registration clinical trial for third-line treatment of LBCL was 77.6%, with a complete response rate (CRR) of 53.5%[91]. - The six-month follow-up results of the RELIANCE study for Benodada® in treating r/r FL showed an ORR of 92.6% and a CRR of 77.8%[95]. - The safety profile of Benodada® indicated a severe cytokine release syndrome (sCRS) occurrence of 5.1% and severe neurotoxicity (sNT) of 3.4% in the LBCL trial, with no treatment-related deaths reported[91]. - The company plans to release four-year follow-up data for Benodada® in the first half of 2024[91]. - The company has initiated a single-arm Phase I/II registration trial for Bynodac® in children and adolescents with r/r ALL, with initial trial data expected in the first half of 2024[183]. Company Overview - The company is a leading clinical-stage cell therapy company in China, focusing on developing, manufacturing, and commercializing breakthrough cell immunotherapies for hematological cancers and solid tumors[200]. - The company was established in 2016 and has built an integrated platform for cell immunotherapy[200]. - The company aims to be a leader in cell immunotherapy through innovation[200]. - The company was registered in the Cayman Islands on September 6, 2017, and its shares were listed on the Hong Kong Stock Exchange on November 3, 2020[199].

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 1,739 million, an increase of 19.3% from RMB 1,457 million for the year ended December 31, 2022, driven by the commercialization of the CAR-T therapy product, Relma-cel[4]. - Loss for the year ended December 31, 2023, was RMB 7,680 million, a decrease from RMB 8,461 million for the year ended December 31, 2022, primarily due to increased revenue and gross profit from Relma-cel and improved operational efficiency[7]. - Adjusted loss decreased from RMB 605.1 million for the year ended December 31, 2022, to RMB 514.5 million for the year ended December 31, 2023, mainly due to increased sales revenue and gross profit from Relma-cel[9]. - Gross profit increased by 50.1% from RMB 58.8 million for the year ended December 31, 2022, to RMB 88.2 million for the year ended December 31, 2023, with a gross margin rising from 40.3% to 50.7%[72]. - The net loss for the year ended December 31, 2023, was RMB 768.0 million, down from RMB 846.1 million for the year ended December 31, 2022, mainly due to increased revenue and gross profit from the sales of the product Beinuoda®[110]. - The company reported a net loss attributable to equity holders of the company for the year was RMB 767,996 thousand, compared to RMB 846,135 thousand in the previous year, reflecting a reduction in losses of approximately 9.2%[138]. Cash and Assets - Cash and cash equivalents as of December 31, 2023, were RMB 1,005.9 million, compared to RMB 451.1 million as of December 31, 2022, with a net cash outflow of RMB 377.4 million for the year[9]. - Total current assets as of December 31, 2023, were RMB 1,067,484 thousand, down from RMB 1,485,168 thousand as of December 31, 2022, representing a decline of about 28.0%[115]. - The total assets decreased to RMB 2,146,097 thousand as of December 31, 2023, from RMB 2,791,347 thousand in 2022, a reduction of approximately 23.1%[115]. - The company had cash and cash equivalents of RMB 1,005,909 thousand as of December 31, 2023, down from RMB 1,383,336 thousand in 2022[143]. Operational Efficiency - Gross margin increased to 50.7% for the year ended December 31, 2023, due to cost reduction initiatives and improved operational efficiency[11]. - The company continues to execute cost reduction plans, enhancing operational efficiency and driving revenue growth[11]. - Sales expenses decreased by 40.7% from RMB 190.9 million for the year ended December 31, 2022, to RMB 113.2 million for the year ended December 31, 2023, primarily due to optimization of the commercial personnel structure[72]. - General and administrative expenses decreased by 22.1% from RMB 179.8 million for the year ended December 31, 2022, to RMB 140.0 million for the year ended December 31, 2023, mainly due to reductions in employee benefits and professional service fees[72]. Product Development and Clinical Trials - The company initiated a clinical trial for Relma-cel in March 2023 for r/r LBCL patients, with patient enrollment starting in November 2023[11]. - The National Medical Products Administration accepted the supplemental new drug application for Relma-cel for r/r MCL patients in January 2024, with priority review granted in December 2023[11]. - The company launched an investigator-initiated trial (IIT) in March 2023 to evaluate Relma-cel for treating moderate to severe active systemic lupus erythematosus (SLE) patients[11]. - The company has initiated clinical development for new cell therapy products based on MAGE-A4 and DLL3, expanding its innovative pipeline[13]. - The company has initiated a single-arm I/II trial for r/r ALL in children and adolescents, with initial data expected to be released in the first half of 2024[46]. Market Position and Strategy - The company is positioned favorably in the growing CAR-T treatment market in China, with expectations of strong growth until 2030[17]. - The company is exploring innovative methods to simplify production processes through non-viral approaches and existing CAR products, aiming to provide effective therapies while controlling costs[13]. - The company has established a differentiated pipeline for cell immunotherapy products, with opportunities to expand into emerging solid tumors and autoimmune disease cell therapies[22]. - The company has expanded its strategic collaboration with 2seventy bio, Inc. for the co-development and commercialization of CAR-T cell products for autoimmune diseases in Greater China, aiming to gain a first-mover advantage in a promising market[23]. Employee and Operational Metrics - The total employee count decreased by 24.6% to 398 as of December 31, 2023, from 528 in the previous year[128]. - The total salary cost for the year ended December 31, 2023, was RMB 308,200 thousand, down from RMB 405,900 thousand in 2022, reflecting a reduction of approximately 24.1%[128]. - Employee benefits expenses decreased to RMB 307,041 thousand in 2023 from RMB 404,328 thousand in 2022, a reduction of approximately 24%[156]. Future Outlook - The company plans to report four-year follow-up data for relma-cel in mid-2024, following a two-year overall survival rate of 69.3% in its clinical trials[34]. - The company plans to continue patient enrollment for ongoing trials and expects to report data in the second half of 2024[80]. - The company aims to leverage the development of CAR-T therapies to gain a first-mover advantage in the SLE treatment market in China[50]. - The company plans to continue increasing the cell dose of JWATM214 after further analysis of efficacy and safety data from the ongoing IIT for advanced HCC patients[58].

Financial Performance - Revenue increased by 32.9% from RMB 66.0 million for the six months ended June 30, 2022, to RMB 87.7 million for the six months ended June 30, 2023, driven by the commercialization of the CAR-T cell therapy product, Relma-cel [54]. - Loss for the six months ended June 30, 2023, was RMB 380.4 million, a decrease from RMB 429.3 million for the same period in 2022, primarily due to increased revenue and improved operational efficiency [23]. - Gross profit increased by 93.9% from RMB 23.1 million for the six months ended June 30, 2022, to RMB 44.8 million for the six months ended June 30, 2023, with a gross margin rising from 35.0% to 51.1% [55]. - Operating loss decreased to RMB 389.92 million for the six months ended June 30, 2023, down from RMB 431.96 million in the same period of 2022, reflecting improved operational efficiency [84]. - The adjusted loss for the six months ended June 30, 2023, was RMB 267.07 million, a reduction from RMB 289.20 million in the same period of 2022, primarily due to increased sales revenue and gross profit from the product Benodara® [86]. - Total revenue for the six months ended June 30, 2023, was RMB 87.74 million, a 32.8% increase from RMB 66.01 million for the same period in 2022 [191]. Research and Development - The company’s R&D expenses details for the six months ended June 30, 2022, and 2023, are provided, indicating ongoing investment in product development [13]. - Research and development expenses rose by 10.5% from RMB 195.9 million for the six months ended June 30, 2022, to RMB 216.5 million for the six months ended June 30, 2023, mainly due to increased depreciation and clinical trial costs [41]. - The company has made significant progress in developing Beinuoda® for treating hematological malignancies and expanding its product portfolio for solid tumors [71]. - The company is developing two dual-targeted autologous CAR T-cell therapies aimed at enhancing efficacy and performance in treating autoimmune diseases and B-cell malignancies [67]. - The company has initiated clinical studies for relma-cel in treating moderate to severe active SLE patients, with IND approval received in April 2023 [93]. - The company is developing two new CAR products for solid tumors, expected to be delivered for clinical use in 2025 [181]. Cost Management - General and administrative expenses decreased from RMB 909 million for the six months ended June 30, 2022, to RMB 787 million for the six months ended June 30, 2023, primarily due to a reduction in employee benefits expenses of approximately RMB 96 million [12]. - Sales expenses decreased by 28.7% to RMB 60.17 million, down from RMB 84.45 million, due to optimized staffing for commercial operations [83]. - The company continues to implement cost reduction strategies, achieving an 18.1% decrease in sales costs per batch compared to the average sales cost in 2022, contributing to the increase in gross margin [74]. - The company continues to execute cost reduction plans, enhancing operational efficiency and reducing cash outflows [88]. - Employee benefits expenses for the six months ended June 30, 2023, were RMB 46,831 thousand, a decrease of 17.1% from RMB 56,462 thousand for the same period in 2022 [196]. Product Development and Commercialization - The company has established a dedicated commercial team for the commercialization of Relma-cel in China, having completed assessments and training for 118 hospitals by June 30, 2023 [124]. - The first product, Beinuoda® (relma-cel), is the first CAR-T cell therapy approved in China for treating adult patients with r/r LBCL and r/r FL after two lines of systemic therapy [97]. - Beinuoda® demonstrated an objective response rate (ORR) of 77.6% and a complete response rate (CRR) of 53.5% in a Phase II clinical trial for third-line LBCL treatment [107]. - The company plans to submit a supplemental new drug application to the National Medical Products Administration by the end of 2023 based on the promising data from ongoing studies [114]. - The company aims to solidify its leadership in hematology through the continued development of its product,倍諾達®, and further expansion into autoimmune disease clinical development [161]. Regulatory Compliance and Governance - The company has fully complied with the listing rules following the appointment of Dr. Debra Yu as a director on March 1, 2023 [18]. - The company has not reported any major shareholders or their associates receiving stock options exceeding the 1% individual limit as per the listing rules [7]. - The company did not engage in any significant acquisitions or disposals during the six months ended June 30, 2023 [16]. Market and Competitive Position - The company expects the superior product characteristics of Relma-cel to provide breakthrough value for patients [54]. - Relma-cel has been approved by the FDA in February 2021, based on the same CAR structure as Juno's product, indicating its competitive positioning in the market [129]. - The company is exploring innovative payment solutions to alleviate the financial burden on patients receiving Beinuoda® treatment [100]. - The company aims to expand its commercial insurance coverage and continue collaborating with leading payment platforms [100].

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之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不就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。 JW (Cayman) Therapeutics Co. Ltd 藥明巨諾（開曼）有限公司* （於開曼群島註冊成立的有限公司） （股份代號：2126） 截至2023年6月30日止六個月之中期業績公告 藥明巨諾（開曼）有限公司（「本公司」）之董事（「董事」）會（「董事會」）欣然公佈 本公司及其附屬公司（統稱「本集團」或「我們」）截至2023年6月30日止六個月（「報 告期間」）之未經審核簡明綜合中期業績，連同2022年相應期間之比較數字。該 等中期業績已由本公司審核委員會（「審核委員會」）及核數師羅兵咸永道會計 師事務所審閱。 中期業績摘要 財務摘要 國際財務報告準則計量： ‧ 收入由截至2022年6月30日止六個月 的人民幣66.0百萬元增加32.9%至截 至2023年6月30日止六個月的人民幣87.7百萬元，該增長是由於我們的 ...