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之有限公司） （股份代號：2171） 年度業績公告 截至2023年12月31日止年度 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（統稱「本集團」）截至2023 年12月31日止年度（「報告期間」）的經審核綜合業績連同截至2022年12月31日止 年度之經審核比較數字。 財務摘要 | --- | --- | --- | |-----------------------------------------------------|-------------------------------|--------------------------| | | | | | | 截至 12 月 31 | 日止年 ...

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 ...

科濟藥業控股有限公司 CARSGEN THERAPEUTICS HOLDINGS LIMITED （於開曼群島註冊成立的有限公司） 股份代號 : 2171.HK ...

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之有限公司） （股份代號：2171） 年度業績公告 截至2022年12月31日止年度 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（統稱「本集團」）截至2022 年12月31日止年度（「報告期間」）的經審核綜合業績連同截至2021年12月31日止 年度之經審核比較數字。 財務摘要 | --- | --- | --- | |--------------------------------------------------------|------------------------------------|-----------------------------| | | | | | | 截至 12 ...

科濟藥業控股有限公司 CARSGEN THERAPEUTICS HOLDINGS LIMITED （於開曼群島註冊成立的有限公司） 股份代號 : 2171.HK 年度報告 2021 目錄 公司資料2 | --- | --- | |----------------------|-------| | 董事長致辭 | 3 | | 財務摘要 | 5 | | 業務摘要 | 6 | | 管理層討論及分析 | 9 | | 董事及高級管理層 | 36 | | 董事會報告 | 45 | | 企業管治報告 | 80 | | 環境、社會及管治報告 | 95 | | 獨立核數師報告 | 136 | | 綜合全面虧損表 | 141 | | | | | 綜合財務狀況表 | 142 | | | | | 綜合權益變動表 | 144 | | 綜合現金流量表 | 145 | | 綜合財務報表附註 | 147 | | | | | 財務概要 | 217 | | 釋義 | 218 | | 詞彙 | 221 | | | | | | | | | | | | | 公司資料 | --- | --- | |--------------------------- ...