本公告乃由浙江同源康醫藥股份有限公司（「本公司」，連同其附屬公司統稱「本 集團」）自願刊發，以告知本公司股東及潛在投資者有關本集團最新業務發展的資 料。 本公司董事（「董事」）會（「董事會」）欣然宣佈重點佈局的細胞周期蛋白依賴性激 酶（「CDK」）抑制劑(CDKi)領域的三款藥物TYK-00540 (CDK2/4i)、TY-2699a (CDK7i)和TY-302 (CDK4/6i)的早期臨床研究結果以壁報形式在歐洲腫瘤內科學 會（「ESMO」）年會上展示。 ESMO 2025年會於當地時間2025年10月17-21日在德國柏林召開。作為全球腫瘤 學領域最具影響力的學術盛會之一，ESMO年會吸引了眾多學界頂尖專家學者， 提供了共同探討臨床難題、分享前沿進展的舞台。 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意見，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。 TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2410） 自願性公 ...

10月21日，国产九价HPV疫苗深圳首针在深圳市龙华区妇幼保健院开打。今年5月，我国首个国产九价 HPV疫苗正式获得国家药品监督管理局批准上市，使中国成为全球第二个能够独立供应高价次HPV疫苗 的国家。 宫颈癌发病率呈现年轻化趋势 宫颈癌是威胁我国女性健康的重要疾病。根据国家癌症中心的报告，2022年我国新发的宫颈癌病例是 15.1万例，居全球首位。同时，自2000年以来，我国宫颈癌的发病率不断上升，呈年轻化趋势，25岁以 下也是中国女性感染HPV的高峰年龄段。HPV是导致女性宫颈癌的"罪魁祸首"，99.7%的宫颈癌与高危 型HPV持续感染相关。而HPV疫苗接种是公认的预防宫颈癌最安全有效的手段之一。 适用于9-45岁女性 （文章来源：南方都市报） 深圳市妇幼保健院宫颈癌防治中心主任樊静洁提到，9-45岁女性可以通过打HPV疫苗获益，有条件的适 龄女性都应该接种HPV疫苗保护自己，早打早保护。其提到，重点需要关注的是9-14岁女孩，广东省初 一女生HPV疫苗免费项目覆盖了这部分重点人群。"国产九价9-17岁免疫程序是打两针，对于低龄段的 女孩子而言，不仅节省费用，还可以少跑一趟打苗。这两年我们也在做'加速消除 ...

Core Viewpoint - Tian Tan Biological announced the initiation of Phase III clinical trials for its "Prothrombin Complex Concentrate," developed by its subsidiary Wuhan Biological Pharmaceutical, following the completion of ethical review and preparatory work for clinical enrollment [1] Group 1: Product Development - The Prothrombin Complex Concentrate is primarily used for the treatment of congenital and acquired deficiencies of coagulation factors II, VII, IX, and X, which include conditions such as Hemophilia B, anticoagulant overdose, and vitamin K deficiency [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice for the clinical trial application of GenSci142 capsules from the National Medical Products Administration [1] Group 1: Product Development - GenSci142 capsules are developed by Jinsai Pharmaceutical and target Gardnerella bacteria [1] - The product utilizes recombinant lytic enzymes selected through bioinformatics screening of phage sequences, which can directly disrupt bacterial cell walls, leading to rapid lysis and death of the bacteria [1]

10月21日，国产九价HPV疫苗深圳首针在深圳市龙华区妇幼保健院开打。 今年5月，我国首个国产九价HPV疫苗正式获得国家药品监督管理局批准上市，使中国成为全球第二个能够独立供 应高价次HPV疫苗的国家。 宫颈癌发病率呈现年轻化趋势 根据国家癌症中心的报告，2022年我国新发的宫颈癌病例是15.1万例，居全球首位。同时，自2000年以来，我国 宫颈癌的发病率不断上升，呈年轻化趋势，25岁以下也是中国女性感染HPV的高峰年龄段。 宫颈癌是威胁我国女性健康的重要疾病。 HPV是导致女性宫颈癌的"罪魁祸首"，99.7%的宫颈癌与高危型HPV持续感染相关。而HPV疫苗接种是公认的预防 宫颈癌最安全有效的手段之一。 适用于9-45岁女性 据介绍，国产九价HPV疫苗适用于9-45岁女性，覆盖中国女性HPV病毒感染的两个高峰期，分别是小于25岁和40- 44岁。 龙华区妇幼保健院预防接种门诊负责人陈文盛介绍，国产九价HPV疫苗涵盖了9种HPV的型别，其中包括7种高危 型别。国产九价HPV疫苗两针法扩龄到17岁(0、6月各打1针)，9岁-17岁的女生能少接种1针次；18-45岁女性则需 要接种3针(0、1、6月各打1针)。 国 ...

Core Insights - The article discusses the first batch of bio-manufacturing landmark products announced by Hubei Province's Economic and Information Technology Department on October 9, highlighting significant advancements in the bio-manufacturing sector [2]. Group 1: Landmark Products - The first batch of landmark bio-manufacturing products includes: - Dongyang Sunshine: Thiocyanate Erythromycin - Tianji Bioenergy: Ultra-clean biodiesel - Bafeng Pharmaceutical: Amino acid raw materials - Xinhua Yang: Feed enzyme preparations - Guangji Pharmaceutical: High-quality riboflavin - China National Pharmaceutical Group: Inactivated vaccine for Porcine Circovirus Type 2 - Aibotai Bio: Research antibodies - Huisheng Biotechnology: Tylosin tartrate - Hite Bio-pharmaceutical: Injectable Epinephrine - Fuxing Biotechnology: Arachidonic acid (ARA) powder [2][3]. Group 2: Product Categories - The products are categorized into different types: - Scale Replacement Type: Thiocyanate Erythromycin, Ultra-clean biodiesel, Research antibodies, Tylosin tartrate - Key Improvement Type: Amino acid raw materials, Feed enzyme preparations, High-quality riboflavin, Arachidonic acid powder - Major Innovation Type: Inactivated vaccine for Porcine Circovirus Type 2, Injectable Epinephrine [3].

Core Viewpoint - Zhifei Biological announced the acquisition of an invention patent for a vaccine and its preparation method, indicating a significant advancement in its product development and potential market competitiveness [1] Company Summary - Zhifei Biological and its wholly-owned subsidiaries, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd. and Beijing Zhifei Lvzhu Biological Pharmaceutical Co., Ltd., have recently obtained a patent certificate from the National Intellectual Property Administration of the People's Republic of China [1] - The patent is titled "A Vaccine and Its Preparation Method" with the patent number ZL202410156676.3, showcasing the company's innovation in vaccine technology [1]

Core Viewpoint - The company is making steady progress on its C1 esterase inhibitor research project and aims to enhance its product structure and core competitiveness through increased R&D efforts [1] Summary by Categories R&D Progress - The C1 esterase inhibitor is progressing smoothly according to the company's statement on the investor interaction platform [1] - The company plans to accelerate the new product launch process as part of its strategy to broaden its product structure [1] Future Expectations - The company acknowledges that the development and approval of new products is a lengthy and high-risk process, indicating that there are uncertainties involved [1] - The company will provide timely updates based on the progress of product development [1]

药明巨诺-B(02126)发布公告，已向中国国家药品监督管理局(NMPA)递交瑞基奥仑赛(relma-cel)在中国 成人活动性系统性红斑狼疮(SLE)患者中的I期研究数据，NMPA已接收数据，并受理会议申请。 SLE是一种慢性自身免疫性疾病，可引起全身多脏器和组织受损。 本次更新的数据是来自于一项在中国开展的I期、单臂、开放、多中心、剂量探索研究，起始剂量设为 50×106CAR+T细胞，采用贝叶斯最优区间(BOIN)设计的剂量探索规则，在50×106CAR+T细胞、 75×106CAR+T细胞、100×106CAR+T细胞三个剂量水准进行探索，以评估瑞基奥仑赛注射液在SLE患者 中的安全性，并最终确定II期研究推荐剂量。 截至2025年7月，本研究已入组了共12例受试者并完成瑞基奥仑赛注射液回输，初步完成了低、中、高 剂量组的安全性，疗效以及药代和药效动力学(PK/PD)的探索。 本次研究中，一共回输了12例患者，均为女性，中位年龄27岁(范围：20至41岁)，中位病史9.5年(范 围：4至20年)。最高SELENA-SLEDAI评分16分，最低评分4分，中位评分10分，均为中重度活动性SLE 患者。11 ...

Core Viewpoint - WuXi AppTec's CAR-T therapy, Relma-cel, has submitted Phase I study data for treating adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China, indicating significant potential for this innovative treatment in a challenging therapeutic area [1][4]. Group 1: Study Overview - The Phase I study is a multicenter, open-label, dose-exploration trial designed to assess the safety and efficacy of Relma-cel in SLE patients, with doses set at 50×10^6, 75×10^6, and 100×10^6 CAR+T cells [1]. - As of July 2025, a total of 12 female patients have been enrolled, with a median age of 27 years and a median disease history of 9.5 years [2]. Group 2: Patient Characteristics - All enrolled patients exhibited moderate to severe active SLE, with a median SELENA-SLEDAI score of 10 [2]. - 100% of patients had renal involvement, and other affected systems included skin (50%), hematologic (50%), and joints (16.7%) [2]. Group 3: Efficacy Results - Among the 12 patients evaluated for 6-month efficacy, 100% achieved SRI-4 response, and 50% met LLDAS criteria, indicating promising therapeutic effects [2]. - Various disease activity scales showed a downward trend, suggesting significant efficacy of Relma-cel in managing SLE [2]. Group 4: Safety Results - Initial safety results indicated that 11 out of 12 patients experienced grade 1 cytokine release syndrome (CRS), with one patient experiencing grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) [3]. - No dose-limiting toxicities (DLT) were reported, highlighting the favorable safety profile of Relma-cel in this patient population [3]. Group 5: Future Prospects - The ongoing study aims to gather longer follow-up data, with the potential for Relma-cel to advance to the biologics license application (BLA) stage [4]. - The company anticipates further discussions with regulatory authorities to expedite the Phase II pivotal study, aiming to provide a breakthrough treatment option for SLE patients [4].