Investment Rating - The report does not specify a clear investment rating for the company [1]. Core Insights - The company reported a revenue of 6.34 million yuan for the first half of 2024, with a net loss of 350 million yuan, which is a reduction of 50 million yuan compared to a net loss of 400 million yuan in the first half of 2023 [2]. - As of June 30, 2024, the company had cash and cash equivalents amounting to 1.65 billion yuan [2]. - The core product, CT053 (赛恺泽), was approved for market launch on March 1, 2024, and has received 52 orders from Huadong Medicine as of the end of July 2024 [2]. - The company plans to submit a New Drug Application (NDA) for CT041 in the first half of 2025, following the completion of patient enrollment in a confirmatory Phase II clinical trial [2]. - The company expects revenues to grow significantly, projecting 100 million yuan in 2024, 300 million yuan in 2025, and 700 million yuan in 2026 [3][10]. Financial Summary - Revenue projections for 2024-2026 are as follows: 1 billion yuan in 2024, 3 billion yuan in 2025, and 7 billion yuan in 2026 [9][10]. - The expected growth rates for revenue are 200% from 2024 to 2025 and 133.33% from 2025 to 2026 [4]. - The net profit attributable to the parent company is projected to be -747.79 million yuan in 2024, -657.51 million yuan in 2025, and -523.17 million yuan in 2026 [4]. - The earnings per share (EPS) are expected to improve from -1.31 yuan in 2024 to -0.33 yuan in 2026 [4].

Financial Performance - The group reported revenue of approximately RMB 6 million for the six months ended June 30, 2024, primarily from the sale of CAR-T product, CARSgen's CT053[5]. - The net loss for the six months ended June 30, 2024, was approximately RMB 352 million, a decrease of about RMB 52 million compared to RMB 404 million for the same period in 2023[7]. - Adjusted net loss for the same period was approximately RMB 342 million, down RMB 44 million from RMB 386 million in the prior year[7]. - The company reported an operating loss of RMB 362 million and RMB 409 million for the six months ended June 30, 2024, and 2023, respectively, primarily due to R&D and administrative expenses[35]. - The adjusted net loss for the six months ended June 30, 2024, was RMB 342.368 million, a decrease from RMB 385.726 million for the same period in 2023, representing a reduction of approximately 11.2%[38]. - The adjusted loss per share improved to RMB (0.61) for the six months ended June 30, 2024, compared to RMB (0.70) for the same period in 2023, reflecting a 12.9% improvement[39]. - The company reported a revenue of RMB 6,340 thousand for the six months ended June 30, 2024, with a gross profit of RMB 1,617 thousand[60]. - Total other income for the six months ended June 30, 2024, was RMB 23,062 thousand, a decrease of 44.8% from RMB 41,605 thousand in the same period of 2023[67]. Cash Flow and Liquidity - Cash and bank balances as of June 30, 2024, were approximately RMB 1,653 million, a decrease of about RMB 197 million from RMB 1,850 million as of December 31, 2023[8]. - The company expects to maintain cash and cash equivalents of no less than RMB 1,350 million by the end of 2024, with sufficient cash flow anticipated until 2027[8]. - The company reported a net cash outflow from operating activities of RMB (255.947) million for the six months ended June 30, 2024, compared to RMB (141.815) million for the same period in 2023[47]. - The net cash used in operating activities for the six months ended June 30, 2024, was RMB 256 million, compared to RMB 142 million for the same period in 2023[48]. - The total borrowings as of June 30, 2024, amounted to RMB 129 million, an increase of RMB 126 million from RMB 3 million as of December 31, 2023[52]. - The debt-to-equity ratio as of June 30, 2024, was 14.23%, up 9.50 percentage points from 4.73% as of December 31, 2023[53]. Research and Development - The company focuses on developing innovative CAR-T cell therapies to address unmet medical needs in hematologic malignancies and solid tumors[9]. - The lead R&D focus in hematologic malignancies is on CT071, targeting GPRC5D, which has shown promising preliminary results in clinical trials[10]. - The company is actively expanding CAR-T applications in solid tumors, including ongoing Phase I trials for pancreatic cancer and gastric cancer[10]. - CARSgen's CT041, targeting Claudin18.2, is undergoing clinical trials for gastric cancer, with recent data published in Nature Medicine[3]. - The company is collaborating with Moderna on preclinical research for a Claudin18.2 mRNA product[3]. - The company has established CAR T cell research and development capabilities, covering target discovery, preclinical research, clinical development, and commercial-scale production[62]. - The company is engaged in clinical trials to evaluate the safety and efficacy of its therapies, with a focus on solid tumors and hematological malignancies[39]. Product Pipeline and Commercialization - CT053 has been commercialized in nearly 20 provinces or cities in China, with over 100 medical institutions covered by insurance[2]. - The company has established a clinical production facility in Shanghai and a commercial GMP facility to support global clinical trials and subsequent commercialization of its pipeline products[4]. - The RTP production facility in North Carolina is expected to produce CAR-T products for 700 patients annually, supporting clinical research and early commercialization in the US, Canada, and Europe[4]. - The product pipeline includes several proprietary CAR-T candidates, with LUMMICAR 1 already launched in China for relapsed/refractory multiple myeloma[11]. - The company received NMPA approval for the new drug application of Zekun (CT053) on February 23, 2024, for treating adult patients with relapsed/refractory multiple myeloma (R/R MM) after at least three lines of therapy[12]. - The exclusive commercialization rights for Zekun in mainland China were granted to East China Pharmaceutical, with an upfront payment of RMB 200 million and regulatory milestone payments of RMB 75 million already received[12]. - The company plans to submit a New Drug Application (NDA) for Shurui (CT041) to NMPA in the first half of 2025, following the completion of patient enrollment in a confirmatory Phase II trial[16]. Technology and Innovation - The company has achieved significant progress in technology innovation and product pipeline in both the US and China[2]. - The company has developed the proprietary THANK-uCAR® technology to enhance the accessibility of allogeneic CAR-T cell therapies, aiming to reduce costs and improve patient outcomes[24]. - The CARcelerate® platform has been established to shorten CAR-T cell manufacturing time to approximately 30 hours, enhancing production efficiency and potentially increasing anti-tumor activity[25]. - The CycloCAR® technology has been developed to improve the efficacy of CAR-T cells against solid tumors, showing superior preclinical results compared to traditional CAR-T cells[26]. - The LADARTM technology has been introduced to improve drug target availability, allowing for precise control of immune cell activity against cancer cells[27]. - The company is exploring combination therapies to enhance the clinical performance of CAR-T treatments, including a collaboration with Moderna to investigate the effects of a cancer vaccine[26]. Market and Strategic Outlook - The global CAR-T cell therapy market is expected to grow further due to rising cancer incidence and the approval of more CAR-T therapies for various indications[33]. - The company aims to develop innovative CAR-T technologies to enhance the efficacy, safety, and affordability of its products, addressing unmet medical needs in cancer treatment[34]. - The company plans to continue expanding in both domestic and global markets through R&D and acquisitions, supported by sufficient bank credit facilities[59]. - Future outlook includes plans for market expansion and potential mergers and acquisitions to enhance growth opportunities[39]. - The company is committed to ongoing research and development of new products and technologies to address unmet medical needs[39]. Corporate Governance and Compliance - The roles of Chairman and CEO are currently held by the same individual, Dr. Li, which the board believes facilitates effective strategic execution[88]. - The audit committee has reviewed and approved the accounting principles adopted by the company, ensuring compliance with relevant standards[94]. - The company has not disclosed any significant events requiring additional disclosure or adjustments after the reporting period[89]. - The company emphasizes the importance of compliance with GMP and regulatory standards in its manufacturing processes[39].

Drug Development and Approvals - The company achieved significant milestones in 2023, including the approval of the new drug application for Sykazai® for treating relapsed or refractory multiple myeloma, expected to be commercialized in collaboration with East China Pharmaceutical[7]. - The ongoing patient enrollment for CT041, a first-in-class CLDN18.2 CAR-T therapy, is anticipated to be completed in the first half of 2024, with a new drug application submission planned for the end of 2024[8]. - The company reported promising efficacy results from GPC3 or CLDN18.2 CAR-T therapies, with some patients showing over 7 years of disease-free survival[9]. - CT053 received conditional approval from the National Medical Products Administration on February 23, 2024, for the treatment of relapsed or refractory multiple myeloma[21]. - CT041 is the world's first CAR-T cell candidate for solid tumors to enter Phase II clinical trials, with IND approval received in April 2023 for pancreatic cancer[22]. - CT071 received IND approval from the FDA on November 30, 2023, for the treatment of relapsed or refractory multiple myeloma and primary plasma cell leukemia[24]. - The company has successfully identified and validated Claudin18.2 as a viable target for CAR-T cell therapy in solid tumors, including gastric and pancreatic cancers[39]. - CT041 received orphan drug designation from the FDA for the treatment of GC/GEJ in September 2020 and from EMA for advanced gastric cancer in January 2021[40]. - CT041's clinical trials in China include an ongoing Phase Ib/II trial, with results presented at the 2022 ASCO annual meeting, and an NDA submission planned for the end of 2024[41]. - CT011, a CAR-T cell candidate for HCC, has completed patient enrollment in a Phase I trial in China, with IND approval received in January 2024[45]. - CT071, targeting GPRC5D, received IND approval in November 2023, but its Phase I trial in the US has been paused due to CMC-related issues[47]. - CT0180 and CT0181 are in investigator-initiated clinical trials in China for HCC, with results presented at the 2023 ASCO annual meeting[49]. - CT0590, a CAR-T cell candidate targeting BCMA, is also in an investigator-initiated clinical trial for R/R MM[50]. Financial Performance - The net loss for the year ended December 31, 2023, was RMB 748 million, a decrease of RMB 144 million compared to a net loss of RMB 892 million for the year ended December 31, 2022[16]. - Adjusted net loss for the year ended December 31, 2023, was RMB 733 million, down RMB 115 million from RMB 848 million for the year ended December 31, 2022[17]. - Cash and bank balances as of December 31, 2023, were RMB 1,850 million, a decrease of RMB 418 million from RMB 2,268 million as of December 31, 2022[17]. - The operating loss for the year ended December 31, 2023, was RMB 768 million, compared to RMB 881 million for the year ended December 31, 2022[76]. - Research and development expenses decreased from RMB 680 million in 2022 to RMB 662 million in 2023, primarily due to reduced employee benefits expenses[82]. - Cash used in operating activities was RMB 455 million in 2023, compared to RMB 643 million in 2022, indicating an improvement in cash flow management[90]. - Cash and cash equivalents decreased from RMB 2,268 million in 2022 to RMB 1,850 million in 2023, a reduction of RMB 418 million primarily due to R&D and administrative expenses[94]. - Total borrowings decreased from RMB 7 million in 2022 to RMB 3 million in 2023, reflecting a reduction in financial liabilities[95]. - The company's debt-to-equity ratio was 4.73% in 2023, slightly down from 4.83% in 2022, indicating stable financial leverage[99]. - Cash generated from investment activities was RMB 39 million in 2023, a significant decrease from RMB 2,387 million in 2022, primarily due to changes in investment strategies[91]. Collaborations and Partnerships - In January 2023, the company entered into a commercialization agreement with East China Pharmaceutical for Sykazai® in mainland China[13]. - The company initiated a collaboration with Moderna in August 2023 to study the combination effects of CT041 with Moderna's experimental Claudin18.2 mRNA cancer vaccine[13]. - The company signed a collaboration agreement with East China Pharmaceutical in January 2023 for the commercialization of CT053 in mainland China[28]. - A commercialization cooperation agreement with East China Pharmaceutical has been signed, providing the company with an upfront payment of RMB 200 million and potential milestone payments up to RMB 1,025 million for the commercialization of the drug Saikaze® in mainland China[69]. - A licensing agreement with HK Inno.N Corporation has been established for the development and commercialization of CT032 and Zewokiolun injection in South Korea, with potential upfront payments totaling up to $50 million[70]. Production and Technology - The proprietary CARcelerateTM technology platform has been developed to reduce production time to approximately 30 hours, enhancing supply capacity and lowering production costs[10]. - The company has established independent vertical integration production capabilities for CAR-T manufacturing, supporting clinical trials and subsequent commercialization[26]. - The proprietary CARcelerateTM platform has reduced the manufacturing time for CT071 to approximately 30 hours, enhancing supply capacity and reducing costs[47]. - The Shanghai Xuhui clinical production facility has a total area of about 3,000 square meters, supporting CAR-T cell therapy for 200 patients annually, with a production success rate exceeding 95% since its establishment[62]. - The commercial production facility in Shanghai Jinshan has an area of approximately 7,600 square meters, estimated to support CAR-T cell therapy for up to 2,000 patients annually, and has received China's first production license for CAR-T cell therapy[62]. - The RTP production facility, completed in September 2022, provides additional capacity to produce autologous CAR-T cell products for 700 patients annually[64]. Research and Development Focus - The company has a comprehensive R&D platform that supports the development of its CAR-T cell therapies, ensuring global rights protection for its candidate products[34]. - The company aims to address significant challenges in CAR-T cell therapy, such as improving safety and efficacy for solid tumors, and reducing treatment costs[31]. - The company plans to conduct additional clinical trials to develop Sai Kai Ze® as an early-line treatment option for multiple myeloma[37]. - The company plans to conduct additional clinical trials to develop CT041 as a first-line treatment for GC/GEJ and PC[44]. - The company is focused on reducing safety issues associated with CAR-T therapies by developing innovative technologies to lower the risks of CRS and neurotoxicity[56]. - The next-generation CAR-T technology, CycloCAR®, shows improved clinical efficacy and reduced pre-treatment requirements, outperforming traditional CAR-T cells in preclinical studies against solid tumors[54]. - The THANK-uCAR® technology aims to produce allogeneic CAR-T cells with better proliferation and persistence, potentially lowering treatment costs and increasing patient accessibility[56]. - The LADAR® technology is being explored to improve drug target availability, allowing previously non-druggable antigens to become promising targets[58]. Corporate Governance and Management - The management team includes experienced professionals with backgrounds in investment management and biomedicine, contributing to strategic decision-making[131][132]. - The board of directors includes independent members with extensive experience in finance and investment, enhancing governance and oversight[132]. - The management team is committed to maintaining high standards of corporate governance and transparency in operations[132]. - The company has a strong leadership team with extensive experience in the pharmaceutical and biotechnology sectors[137][138]. - The board of directors has undergone changes, with Dr. Li Huabing appointed as an independent non-executive director on March 9, 2023, and Ms. Zhao Xiangke appointed on July 4, 2023[151]. - Dr. Fan Chunhai and Mr. Su Deyang resigned as independent non-executive directors due to other business commitments[151]. Market and Shareholder Information - As of December 31, 2023, the company has a total issued share capital of 575,640,021 shares[171]. - Dr. Li Zonghai, Mr. Guo Bingsen, Dr. Wang Huamao, and Mr. Guo Huaqing collectively own 215,572,730 shares, representing 37.45% of the company's equity[171]. - Yijie Biotechnology holds 198,139,536 shares, accounting for 34.42% of the company's equity[171]. - The company has established a concert party agreement among key shareholders, which includes Dr. Li Zonghai and others, regarding the ownership of shares[171]. - The company has not disclosed any additional interests or short positions held by directors or senior management as of December 31, 2023[172]. - The company has not identified any other individuals with recorded interests in shares as of December 31, 2023[174]. - The total equity interest of the major shareholders is consistent across various entities, all holding 37.45% of the company's equity[173]. Risks and Challenges - The company has incurred significant net losses and operating cash outflows since its establishment, with expectations to continue this trend in the foreseeable future[161]. - The company relies heavily on the success of its candidate products, all of which are in preclinical or clinical development stages, posing a risk of severe business impact if clinical development is unsuccessful[164]. - The lengthy and costly clinical development process for biopharmaceutical products introduces high uncertainty, with early research results not necessarily predicting future outcomes[164]. - The company faces challenges in establishing promotional and sales capabilities for its candidate products, which may hinder its ability to generate product revenue[169]. - Regulatory approval processes are lengthy and unpredictable, and failure to obtain such approvals could severely damage the company's business[164]. - The complexity of the production process for candidate products may lead to difficulties, potentially delaying clinical trials or commercial supply[165]. - The company has limited experience in launching and promoting products, which could impact its market opportunities[169]. - The company is exposed to risks related to intellectual property, including potential competition from third parties if adequate protections are not maintained[169].

股 票 研 究 [Table_industryInfo] 医药 [ Table_Main[科I Tnaf 济bol]e 药_Ti业tle] - B（2171） [评Tab级le_：Inv est] 增持 当前价格（港元）： 6.04 赛恺泽获批上市，商业化放量可期 2024.04.07 海 ——科济药业2023 年报点评 [ 交Ta易bl数e_M据a rket] 外 丁丹(分析师) 甘坛焕(分析师) 52周内股价区间（港元） 3.91-14.86 当前股本（百万股） 576 公 0755-23976735 021-38675855 当前市值（百万港元） 3,477 司 dingdan@gtjas.com gantanhuan028803@gtjas.com 证书编号 S0880514030001 S0880523080007 （ [ Table_PicQuote] 中 本报告导读： 52周内股价走势图 国 赛恺泽获批上市，华东医药助力其商业化放量，CT041治疗≥3L胃癌有望于今年底 科济药业-B 恒生指数 香 递交NDA，看好公司长期发展，维持“增持”评级。 12% 摘要： 港 -5% [T able维_ ...

Investment Rating - The report does not specify a clear investment rating for the company [1]. Core Insights - The company reported a net loss of 750 million yuan in 2023, a decrease from 890 million yuan in 2022 [2]. - The core product, CT053, has been approved for market launch, targeting adult patients with relapsed or refractory multiple myeloma [2]. - The company is expanding its global production capacity, establishing vertical integration in three key stages of CAR-T manufacturing [3]. - Revenue forecasts for 2024-2026 are projected at 100 million yuan, 300 million yuan, and 700 million yuan respectively [4][10]. Financial Summary - For 2023, the company had cash and cash equivalents of 1.85 billion yuan [2]. - The expected revenue growth rates for 2024, 2025, and 2026 are 200% and 133.33% respectively [4]. - The net profit attributable to the parent company is projected to improve from -747.79 million yuan in 2023 to -215.37 million yuan in 2026 [4]. - Earnings per share (EPS) is expected to improve from -1.30 yuan in 2023 to -0.37 yuan in 2026 [4].

Financial Performance - The net loss for the year ended December 31, 2023, was RMB 748 million, a decrease of RMB 144 million compared to the net loss of RMB 892 million for the year ended December 31, 2022[3]. - Adjusted net loss for the year ended December 31, 2023, was RMB 733 million, down RMB 115 million from RMB 848 million for the year ended December 31, 2022[3]. - The company reported a net loss of RMB 747.794 million for the year ended December 31, 2023, compared to a net loss of RMB 892.247 million for the year ended December 31, 2022, indicating a reduction in losses of approximately 16.2%[42]. - Adjusted net loss decreased from RMB 848.252 million in 2022 to RMB 733.336 million in 2023, reflecting a 13.5% improvement[42]. - The operating loss for the year ended December 31, 2023, was RMB 768 million, compared to RMB 881 million for the year ended December 31, 2022, primarily due to reduced R&D and administrative expenses[38]. - The company reported a net loss before tax of RMB (30,837) thousand in 2023 compared to a net loss of RMB (100,796) thousand in 2022, indicating an improvement in financial performance[71]. - The company’s basic loss per share for 2023 was RMB (1.34), a decrease from RMB (1.62) in 2022, with total losses attributable to ordinary equity holders amounting to RMB (747,794) thousand in 2023 compared to RMB (892,247) thousand in 2022[80]. Cash and Bank Balances - Cash and bank balances as of December 31, 2023, were RMB 1,850 million, a decrease of RMB 418 million from RMB 2,268 million as of December 31, 2022[3]. - The company had cash and cash equivalents of RMB 1.849752 billion at the end of 2023, down from RMB 2.268036 billion at the end of 2022[49]. - Cash used in operating activities was RMB 454.935 million for the year ended December 31, 2023, compared to RMB 643.048 million in 2022, showing a decrease of about 29.3%[49]. - The net cash generated from investment activities was RMB 39.251 million in 2023, significantly lower than RMB 2.38699 billion in 2022, primarily due to the redemption of fixed-term deposits[52]. - The net cash used in financing activities was RMB 22.142 million in 2023, compared to RMB 236.514 million in 2022, indicating a substantial reduction in financing outflows[53]. Research and Development - The company is focused on developing innovative CAR-T therapies to address significant challenges in safety and efficacy for solid tumors and blood malignancies[10]. - The company has established a comprehensive R&D platform for CAR-T cell therapy, from target discovery to commercial-scale production[10]. - The company aims to continue investing in research and development to expedite the approval of candidate products for market launch, anticipating future operational revenue[51]. - The company is actively pursuing regulatory approvals, including BLA submissions, to expedite the market entry of its innovative therapies[93]. - The company has initiated several clinical trials, including Phase I and II studies, to evaluate the safety and efficacy of its drug candidates[96]. Clinical Trials and Approvals - CT041 is the world's first CAR-T cell candidate for solid tumors to enter Phase II clinical trials, with IND approval received in April 2023 for treating Claudin18.2 positive pancreatic cancer[5]. - CT071 received IND approval from the FDA on November 30, 2023, for treating relapsed or refractory multiple myeloma and relapsed/refractory primary plasma cell leukemia[7]. - Zewokaiolun is currently in a Phase II clinical trial for treating relapsed/refractory multiple myeloma, with over 100 patients enrolled in the North American trial[14]. - The Phase 1b/2 clinical trial for CT041 in advanced GC/GEJ was initiated in May 2023 but has been paused due to CMC-related issues at the RTP manufacturing facility[17]. - The company plans to conduct additional clinical trials to develop Zewokaiolun as an early-line treatment for multiple myeloma[15]. Manufacturing and Production Capacity - The RTP manufacturing facility is expected to provide additional capacity to produce autologous CAR-T cell products for 700 patients annually, supporting clinical research and early commercialization in the US, Canada, and Europe[7]. - The company has established a vertically integrated production capability for CAR-T manufacturing, including plasmid production, lentiviral vector production, and CAR-T cell production[7]. - The Shanghai Jinshan commercial production facility, covering approximately 7,600 square meters, is estimated to support CAR-T cell treatment for up to 2,000 patients annually and has received the first production license for CAR-T cell therapy in China[30]. - The company is expanding its production capacity in China and the United States to support clinical trials and future commercialization of its pipeline products[30]. - The company has developed comprehensive manufacturing and commercialization capabilities, raising HKD 601.6 million, with HKD 545.2 million utilized[87]. Collaborations and Partnerships - The company signed a collaboration agreement with Huadong Medicine for the commercialization of its lead candidate, Zewokaiolun, in mainland China in January 2023[8]. - The collaboration with Moderna aims to explore the combination effects of CT041 with Moderna's experimental vaccine[8]. - The company has established a licensing agreement with HK Inno.N Corporation for the development and commercialization of CT032 and a related injection in South Korea, with potential upfront payments totaling up to $50 million[34]. - A commercialization cooperation agreement was signed with East China Pharmaceutical for the drug Sai Kai Ze®, which includes an upfront payment of RMB 200 million and potential milestone payments up to RMB 1,025 million[33]. Market and Growth Strategy - The company aims to become a global leader in biopharmaceuticals by providing innovative and differentiated cell therapies for cancer patients[10]. - The global CAR-T cell therapy market has been experiencing strong growth, driven by rising cancer incidence and the approval of more CAR-T therapies for various cancer types[36]. - The company plans to continue expanding in both domestic and global markets through self-development, mergers, and acquisitions[62]. - The company is focusing on expanding its market presence through strategic partnerships and collaborations in the biopharmaceutical sector[94]. Risks and Forward-Looking Statements - The company emphasizes that it cannot guarantee the successful development or commercialization of its products, urging shareholders and potential investors to act cautiously[16]. - The company advises stakeholders to refer to its annual and interim reports for detailed information on major risks and uncertainties[97]. - The announcement highlights that actual events or results may differ significantly from those projected in forward-looking statements due to uncontrollable assumptions and factors[97]. - The company does not make any representations or guarantees regarding the realization or reasonableness of any forecasts, targets, estimates, or expectations mentioned in the announcement[97].

证券研究报告 | 公司点评 2024年03月01日 科济药业-B（02171.HK） BCMA CAR-T 中国获批上市，达成商业化里程碑 事件：科济药业宣布赛恺泽®（泽沃基奥仑赛注射液，CT053）上市申请已获得 买入（维持） NMPA批准，用于治疗复发或难治性多发性骨髓瘤（MM）成人患者，既往经过至 股票信息 少3线治疗后进展（至少使用过一种蛋白酶体抑制剂及免疫调节剂）。 赛恺泽®为自体BCMA靶向CAR-T细胞产品，通过慢病毒转导T细胞，CAR包括 行业 生物技术 全人源BCMA特异性单链可变片段（scFv），人CD8α铰链结构域、CD8α跨膜结 前次评级 买入 构域、4-1 BB协同刺激结构域及CD3ζ激活结构域。自研的新全人源scFv具有较 2月29日收盘价(港元) 6.66 高的结合亲和力和稳定性。公司已与华东医药就赛恺泽达成商业化合作协议，借 总市值(百万港元) 3,833.78 助华东医药在血液领域强大商业化能力，充分开发国内市场价值。 总股本(百万股) 575.64 我国多发性骨髓瘤患者数持续增加，赛恺泽填补未被满足临床需求。多发性骨髓 其中自由流通股(%) 100.00 瘤约占所有血液肿瘤 ...

证券研究报告·海外公司点评·药品及生物科技(HS) 科济药业-B（02171.HK） 科济药业事件点评：CT053 获批上市，看好 2024 年 03月 03日 MM 的商业化前景 证券分析师 朱国广 买入（维持） 执业证书：S0600520070004 zhugg@dwzq.com.cn [Table_EPS] 盈利预测与估值 2021A 2022A 2023E 2024E 2025E 股价走势 营业总收入（百万元） 27.05 0.08 100.00 150.00 360.00 同比 -99.70% 124,900.00% 50.00% 140.00% 科济药业-B 恒生指数 归母净利润（百万元） -4,744.42 -892.25 -690.16 -739.49 -598.43 -5% -13% 同比 -345.88% 81.19% 22.65% -7.15% 19.08% -- 22 91 %% -37% EPS-最新摊薄（元/股） -8.24 -1.55 -1.20 -1.28 -1.04 -45% -53% -61% P/E（现价&最新摊薄） - - - - - -- 76 79 %% [关Ta键 ...

Financial Performance - Net loss for the six months ended June 30, 2023, was RMB 404.5 million, an increase of RMB 28 million compared to RMB 376.3 million for the same period in 2022[4] - Adjusted net loss for the six months ended June 30, 2023, was RMB 385.7 million, an increase of RMB 33 million compared to RMB 352.9 million for the same period in 2022[5] - The company's operating loss for the six months ended June 30, 2023 was RMB 409 million, compared to RMB 368 million for the same period in 2022[34] - Net loss for the six months ended June 30, 2023 was RMB 404 million, an increase of RMB 28 million compared to the same period in 2022[35] - Adjusted net loss for the six months ended June 30, 2023 was RMB 385.7 million, compared to RMB 352.9 million for the same period in 2022[37] - Adjusted net loss per share for the six months ended June 30, 2023 was RMB 0.70, compared to RMB 0.65 for the same period in 2022[38] - R&D expenses increased by RMB 7 million to RMB 323 million for the six months ended June 30, 2023, mainly due to increased depreciation of property, plant, and equipment[40] - Administrative expenses for the six months ended June 30, 2023, decreased to RMB 62.3 million from RMB 63.0 million in the same period in 2022, a reduction of RMB 1 million[41] - Employee benefit expenses decreased to RMB 173.1 million in the first half of 2023 from RMB 179.7 million in the same period in 2022, primarily due to a reduction in headcount and related salary and benefit costs[42] - Share-based compensation expenses decreased to RMB 18.7 million in the first half of 2023 from RMB 23.5 million in the same period in 2022[43] - Net cash used in operating activities was RMB 141.8 million for the six months ended June 30, 2023, compared to RMB 310.5 million in the same period in 2022[45] - Net cash used in investing activities was RMB 404.5 million for the six months ended June 30, 2023, primarily due to investments in term deposits and equipment purchases[47] - Net cash used in financing activities was RMB 7.5 million for the six months ended June 30, 2023, mainly due to payments for lease liabilities and bank borrowings[48] - Cash and cash equivalents decreased to RMB 1,683.9 million as of June 30, 2023, from RMB 2,268.0 million as of December 31, 2022[49] - Total cash and cash equivalents, including term deposits with maturities of 3 to 12 months, decreased to RMB 2,174.0 million as of June 30, 2023, from RMB 2,268.0 million as of December 31, 2022[50] - Total borrowings decreased to RMB 5 million as of June 30, 2023, from RMB 7 million as of December 31, 2022[51] - The company's debt-to-equity ratio increased to 5.04% as of June 30, 2023, from 4.83% as of December 31, 2022[51] - The company's operating loss for the first half of 2023 was RMB 409.23 million, compared to RMB 367.69 million in the same period last year[101] - R&D expenses for the first half of 2023 increased to RMB 323.31 million, up from RMB 316.30 million in the same period last year[101] - The company's total assets as of June 30, 2023, were RMB 2.64 billion, a decrease from RMB 2.76 billion at the end of 2022[102] - Cash and cash equivalents as of June 30, 2023, stood at RMB 1.68 billion, compared to RMB 2.27 billion at the end of 2022[102] - The company's net financial income for the first half of 2023 was RMB 4.76 million, compared to a net financial cost of RMB 8.65 million in the same period last year[101] - Other income for the first half of 2023 increased significantly to RMB 41.61 million, up from RMB 10.39 million in the same period last year[101] - The company's total comprehensive loss attributable to equity holders for the first half of 2023 was RMB 290.76 million, compared to RMB 233.58 million in the same period last year[101] - Total equity decreased from RMB 2,473,174 thousand as of December 31, 2022, to RMB 2,205,594 thousand as of June 30, 2023, reflecting a decline in reserves[103] - Total liabilities increased from RMB 289,645 thousand as of December 31, 2022, to RMB 439,363 thousand as of June 30, 2023, driven by higher current liabilities[103] - The company reported a net loss of RMB 404,472 thousand for the six months ended June 30, 2023, compared to a net loss of RMB 376,338 thousand for the same period in 2022[104] - Cash and cash equivalents decreased by RMB 553,845 thousand during the six months ended June 30, 2023, primarily due to net cash outflows from operating and investing activities[105] - Operating cash outflow was RMB 141,815 thousand for the six months ended June 30, 2023, compared to RMB 310,464 thousand for the same period in 2022[105] - Investing activities resulted in a net cash outflow of RMB 404,526 thousand for the six months ended June 30, 2023, mainly due to payments for fixed-term deposits[105] - The company's reserves decreased from RMB 2,473,173 thousand as of December 31, 2022, to RMB 2,205,593 thousand as of June 30, 2023[103] - Lease liabilities decreased slightly from RMB 94,938 thousand as of December 31, 2022, to RMB 89,879 thousand as of June 30, 2023[103] - The company issued shares to employees under share-based payment plans, resulting in a total transaction amount of RMB 23,177 thousand for the six months ended June 30, 2023[104] - Cash and cash equivalents stood at RMB 1,683,951 thousand as of June 30, 2023, compared to RMB 2,268,036 thousand as of December 31, 2022[105] - The company's total financial liabilities as of June 30, 2023, amounted to RMB 206,419 thousand, with RMB 104,113 thousand due within one year, RMB 19,377 thousand due in one to two years, RMB 46,200 thousand due in two to five years, and RMB 36,729 thousand due after five years[113] - Government grants received by the company for the six months ended June 30, 2023, increased to RMB 10,869 thousand, compared to RMB 4,419 thousand in the same period in 2022[117] - Interest income from time deposits with original maturities of three to twelve months for the six months ended June 30, 2023, was RMB 30,736 thousand, a significant increase from RMB 5,969 thousand in the same period in 2022[117] - The company's lease liabilities as of June 30, 2023, totaled RMB 122,621 thousand, with RMB 20,315 thousand due within one year, RMB 19,377 thousand due in one to two years, RMB 46,200 thousand due in two to five years, and RMB 36,729 thousand due after five years[113] - The company's total financial liabilities as of December 31, 2022, were RMB 223,945 thousand, with RMB 112,551 thousand due within one year, RMB 21,482 thousand due in one to two years, RMB 50,332 thousand due in two to five years, and RMB 39,580 thousand due after five years[113] - Foreign exchange loss net amount was RMB 65.259 million in 2023, compared to a gain of RMB 2.313 million in 2022[118] - Total employee benefits expenses decreased to RMB 173.113 million in 2023 from RMB 179.666 million in 2022[119] - Testing and clinical expenses decreased to RMB 101.474 million in 2023 from RMB 108.336 million in 2022[119] - Depreciation of property, plant, and equipment increased to RMB 30.8 million in 2023 from RMB 19.138 million in 2022[119] - Net financial income was RMB 4.758 million in 2023, compared to a net financial cost of RMB 8.646 million in 2022[120] - Basic loss per share was RMB 0.73 in 2023, compared to RMB 0.69 in 2022[128] - Total comprehensive loss attributable to equity holders was RMB 404.472 million in 2023, compared to RMB 376.338 million in 2022[128] - Weighted average number of ordinary shares outstanding increased to 555.475 million in 2023 from 549.356 million in 2022[128] - No provision was made for Hong Kong profits tax as there was no estimated taxable profit[122] - No provision was made for U.S. federal corporate income tax as there was no taxable profit[124] - The company's total property, plant, and equipment (PPE) increased from CNY 469.09 million in 2022 to CNY 507.23 million in 2023, reflecting growth in assets[132] - Depreciation expenses for the six months ending June 30, 2023, amounted to CNY 30.8 million, compared to CNY 19.14 million in the same period in 2022[134] - The net book value of buildings decreased from CNY 47.10 million at the beginning of 2023 to CNY 45.04 million by June 30, 2023, due to depreciation[132] - The company added new assets worth CNY 6.48 million during the first half of 2023, including equipment and leasehold improvements[132] - The net book value of equipment increased slightly from CNY 104.78 million at the start of 2023 to CNY 103.30 million by mid-2023, despite depreciation[132] - The company completed construction-in-progress projects worth CNY 6.53 million during the first half of 2023[132] - The company's R&D expenses for the six months ending June 30, 2023, were CNY 28.39 million, a significant increase from CNY 13.98 million in the same period in 2022[134] - The company's administrative expenses for the six months ending June 30, 2023, were CNY 2.41 million, a decrease from CNY 5.15 million in the same period in 2022[134] - The company's total depreciation and amortization expenses for the six months ending June 30, 2023, were CNY 30.80 million, compared to CNY 19.14 million in the same period in 2022[134] - The company's land use rights had a net book value of RMB 6,552,000 as of June 30, 2023, compared to RMB 6,630,000 as of December 31, 2022, with these assets being used as collateral for loans[136] - The total net book value of intangible assets (software and patents) decreased from RMB 14,476,000 at the beginning of 2023 to RMB 9,285,000 by June 30, 2023, due to additions, write-offs, and amortization expenses[138] - R&D expenses related to intangible assets increased to RMB 2,999,000 in the first half of 2023, up from RMB 2,681,000 in the same period of 2022[139] - The company's other non-current assets and prepayments decreased from RMB 6,321,000 at the end of 2022 to RMB 4,915,000 by June 30, 2023, primarily due to a reduction in prepayments for property, plant, and equipment[140] - Other receivables increased significantly from RMB 11,834,000 at the end of 2022 to RMB 20,509,000 by June 30, 2023, mainly due to a substantial increase in interest receivables[141] - Cash and cash equivalents decreased from RMB 2,268,036,000 at the end of 2022 to RMB 1,683,921,000 by June 30, 2023, with a notable increase in USD-denominated time deposits maturing between 3 to 12 months[143] - Cash and cash equivalents, along with term deposits with original maturities of 3 to 12 months, totaled RMB 2,196,295 thousand as of June 30, 2023, compared to RMB 2,281,654 thousand as of December 31, 2022[144] - Total financial liabilities amounted to RMB 189,770 thousand as of June 30, 2023, down from RMB 205,448 thousand as of December 31, 2022[145] - The company issued 685,834 ordinary shares to employees under the employee share option plan for a total consideration of HKD 4,913,000 (approximately RMB 4,431,000) during the six months ended June 30, 2023[147] - The company allocated and issued 2,012,554 shares to Carfe Unity Limited, a trustee of the 2019 Share Incentive Plan, on June 21, 2023[147] - The company transferred 320,407 treasury shares to employees under the employee incentive plan for a total cost of HKD 897 (approximately RMB 770) during the six months ended June 30, 2023[149] - The company granted 3,394,000 share options under the 2023 Share Option Plan with an exercise price of HKD 14.46 per option[151] - The fair value of the share options granted under the 2023 Share Option Plan was RMB 19,193 thousand at the grant date[152] - The company granted 2,012,554 restricted shares under the 2023 Restricted Share Unit Plan[154] - The fair value of the restricted shares granted under the 2023 Restricted Share Unit Plan was RMB 25,461 thousand at the grant date[155] - Share-based compensation expenses totaled RMB 18,746 thousand for the six months ended June 30, 2023, compared to RMB 23,450 thousand for the same period in 2022[157] - Capital reserves increased to RMB 54,800 thousand as of June 30, 2023, primarily from equity contributions by Shanghai Yijie Biotech[159][161] - Accumulated losses widened to RMB 7,846,507 thousand in H1 2023, up from RMB 7,442,035 thousand at the end of 2022[160] - Total borrowings decreased to RMB 4,979 thousand as of June 30, 2023, down from RMB 7,373 thousand at the end of 2022[162][163] - Lease liabilities stood at RMB 106,109 thousand as of June 30, 2023, with current portion of RMB 16,230 thousand[165] - Deferred income declined to RMB 21,517 thousand as of June 30, 2023, compared to RMB 27,745 thousand at the end of 2022[167] - Accrued expenses and other payables totaled RMB 116,688 thousand as of June 30, 2023, down from RMB 141,114 thousand at the end of 2022[168][169] - Contract liabilities for CT053 exclusive distribution rights amounted to RMB 188,679 thousand as of June 30, 2023, with no comparable figure as of December 31, 2022[170] - The company's subsidiary, Kaixing Life Technology, received an upfront payment of RMB 200 million (RMB 188,679,000 excluding VAT) under the agreement with Huadong Medicine for the exclusive commercialization rights of CT053 in mainland China[170] - Capital commitments for property, plant, and equipment increased to RMB 3,381 thousand as of June 30, 2023, compared to RMB 2,923 thousand as of December 31, 2022[171] - Lease commitments for short-term and low-value leases not yet commenced amounted to RMB 781 thousand as of June 30, 2023, up from RMB 179 thousand as of December 31, 2022[172] - Total compensation for key management personnel decreased to RMB 18,823 thousand for the six months ended June 30, 2023, from RMB 20,218 thousand for the same period in 2022[174] CAR-T Cell Therapy Development - Zevor-cel (CT053), a CAR-T cell therapy candidate for relapsed/refractory multiple myeloma (R/R MM), has its NDA under priority review in China, with expected approval by the end of 2023 or early 2024[6] - CT041, a CAR-T cell therapy candidate targeting Claudin18.2, is the first CAR-T cell therapy for solid tumors to enter Phase II clinical trials globally[7] - CT041 received IND approval in China in April 2023 for adjuvant treatment of Claudin18.2-positive pancreatic cancer (PC)[7] - CT041 initiated Phase II clinical trials in the US in May 2023 for advanced gastric cancer/esophagogastric junction adenocarcinoma (GC/GEJ) patients with Claudin18.2 expression[7] - Collaboration agreement signed with Huadong Medicine for the commercialization of Zevor-cel in mainland China[6] - Ongoing Phase II clinical trials for CT041 in the US and Canada for advanced GC and PC (CT041-ST-02, NCT04404595)[7] - Ongoing Phase Ib and confirmatory Phase II clinical trials for CT041 in China for advanced GC/GEJ and PC (CT041-ST-01, NCT04581473)[7] - The company has established independent and vertically integrated production capabilities for CAR-T manufacturing, covering plasmid production, lentiviral vector production, and CAR-T cell production[8] - The company's RTP manufacturing facility in Durham, North Carolina, provides additional capacity to produce

香港交易及結算所有限公司、香港聯合交易所有限公司及香港中央結算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。 CARsgen Therapeutics Holdings Limited 科濟藥業控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2171） 中期業績公告 截至2023年6月30日止六個月 科濟藥業控股有限公司（「本公司」、「科濟藥業」或「科濟」）董事（「董事」）會（「董 事會」）欣然公佈本公司、其附屬公司及併表聯屬實體（「本集團」或「我們」）截至 2023年6月30日止六個月（「報告期間」）的未經審核綜合中期業績連同2022年同期 之比較數字。 財務摘要 | --- | --- | --- | |--------------------------------------------------------|----------------------------------|-----------------------------------| | | 截至 6 ...