格隆汇12月24日丨长风药业(02652.HK)发布公告，由公司主导的新型吸入式核酸药物开发项目("项目") 近期获选为2025年江苏省科技重大专项"创新生物药"项目。本项目聚焦于小核酸("siRNA")药物在肺部 递送中的关键挑战，致力于推动吸入式核酸候选药物的转化研究与临床前开发。本项目计划支持针对呼 吸系统重大疾病(包括哮喘、慢性阻塞性肺病及肺纤维化)的吸入式核酸候选药物研发工作。工作范围涵 盖递送体系优化、药剂学与工艺开发、临床前研究，以及新药临床试验申请准备。 公司认为，本项目的入选对集团具有重要战略意义，进一步验证了集团技术平台的实力。递送技术是 siRNA肺部治疗的关键壁垒。对此，公司已自主研发出一套高效肺靶向递送系统，相关候选药物在临床 前研究中显示出良好的治疗潜力。本项目的入选，体现了相关部门及评审专家对公司与合作单位在前沿 递送技术领域联合研发能力的充分认可。 ...

Core Insights - The company Beihai Kangcheng-B (01228) announced that its domestically developed enzyme replacement therapy CAN103 has been included in China's first version of the "Commercial Insurance Innovative Drug Directory," which will be implemented starting January 1, 2026 [1] Group 1: Product Development - CAN103 was approved for market launch on May 13, 2025, making it the first domestically developed enzyme replacement therapy for adolescents aged 12 and older, as well as adults with Type I and Type III Gaucher disease in China [1] - On July 2, 2025, CAN103 was officially prescribed at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, marking its entry into clinical application [1] Group 2: Market Impact - The inclusion of CAN103 in the insurance directory is considered a milestone achievement for the company, as it ensures that Gaucher disease patients will have access to safe and effective domestic enzyme replacement therapy, providing broader and more comprehensive treatment coverage [1]

Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. is advancing its strategic initiatives by planning to issue H-shares and has received recognition for its innovative drug T-Bren, which targets HER2-positive gastric cancer patients [1][2][3] Group 1: Trading Information - As of November 4, 2025, Baili Tianheng's stock closed at 362.0 yuan, down 5.22%, with a turnover rate of 1.4% and a trading volume of 14,400 shares, amounting to a total transaction value of 530 million yuan [1] - On the same day, the net outflow of main funds was 17 million yuan, accounting for 3.21% of the total transaction value, while retail investors experienced a net outflow of 3.84% [1][3] Group 2: Company Announcements - The company held its fifth board meeting on November 4, 2025, where it unanimously approved the proposal for the global issuance of H-shares and listing on the Hong Kong Stock Exchange [1][3] - The board also approved the establishment of governance policies applicable post-H-share issuance, including diversity policies and shareholder communication procedures [1] Group 3: Product Development - The innovative drug T-Bren (HER2 ADC) has been included in the list of breakthrough therapy products by the National Medical Products Administration, targeting HER2-positive locally advanced or metastatic gastric cancer patients [2] - T-Bren is classified as a Class 1 biological product and has shown significant anti-tumor efficacy in clinical trials, with 14 ongoing trials covering various cancers [2]

Core Viewpoint - The company, Bai Li Tian Heng (688506.SH), has announced that its self-developed innovative biopharmaceutical T-Bren (HER2 ADC) has shown significant anti-tumor efficacy in clinical trials and has been included in the list of breakthrough therapies by the National Medical Products Administration for patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed prior treatments [1] Group 1 - T-Bren (HER2 ADC) is a targeted innovative ADC with best-in-class potential [1] - The drug has demonstrated significant anti-tumor efficacy in clinical trials [1] - It is specifically for patients who have failed first-line anti-HER2 treatment and standard chemotherapy [1] Group 2 - The National Medical Products Administration has included T-Bren in its list of breakthrough therapies [1] - The announcement indicates a positive regulatory recognition for the drug's potential [1] - The completion of the public announcement signifies a step forward in the drug's development process [1]

Core Viewpoint - The company, BaiLi TianHeng (688506.SH), announced that its innovative biopharmaceutical T-Bren (HER2ADC) has been included in the list of breakthrough therapies for patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed prior first-line anti-HER2 treatment and first-line standard chemotherapy [1] Group 1 - T-Bren is recognized for its best-in-class potential and has demonstrated significant anti-tumor efficacy in clinical trials [1] - The company is currently conducting 14 clinical trials for T-Bren, covering multiple HER2-positive tumor indications both domestically and internationally [1]

Core Viewpoint - The company Baillie Gifford has announced the completion of the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical T-Bren (HER2ADC), which is being compared to pembrolizumab combined with platinum-based chemotherapy for first-line treatment of advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations [1] Group 1 - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The Phase III clinical study comparing T-Bren to pembrolizumab combined with platinum-based chemotherapy has recently entered the trial phase and completed the first patient enrollment [1] Group 2 - Currently, T-Bren is involved in 14 clinical trials both domestically and internationally, including 5 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The trials cover various indications, including first-line and second-line HER2-positive breast cancer, post-operative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-mutated non-squamous non-small cell lung cancer, as well as lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors [1]

Core Viewpoint - The company, BaiLi Tianheng (688506.SH), has announced the completion of the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical, T-Bren (HER2 ADC), targeting HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after first-line anti-HER2 treatment failure [1] Group 1 - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The Phase III clinical trial for T-Bren has recently entered the first patient enrollment stage, focusing on patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma [1] Group 2 - Currently, T-Bren is involved in 13 clinical trials both domestically and internationally, including 4 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The clinical trials cover various indications, including first-line and second-line HER2-positive breast cancer, postoperative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, as well as lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors [1]

Core Viewpoint - The company, Bai Li Tian Heng, has announced the completion of the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical, T-Bren (HER2 ADC), targeting HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after failure of first-line anti-HER2 therapy [1] Group 1: Product Development - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The clinical research for T-Bren has entered Phase III and completed the first patient enrollment for the specified indication [1] Group 2: Clinical Trials Overview - Currently, T-Bren is involved in 13 clinical trials domestically and internationally, including 4 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The trials cover various indications, including first-line and second-line HER2-positive breast cancer, postoperative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, and HER2-positive gastric or gastroesophageal junction adenocarcinoma, as well as lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors [1]

Core Viewpoint - The company, Bai Li Tian Heng, has completed the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical, T-Bren (HER2ADC), targeting HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after first-line anti-HER2 treatment failure [1] Group 1: Product Development - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The clinical research for T-Bren has entered Phase III and completed the first patient enrollment for the specified indication [1] Group 2: Clinical Trials - Currently, T-Bren is involved in 13 clinical trials domestically and internationally, including 4 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The trials cover various indications, including first-line and second-line HER2-positive breast cancer, postoperative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, as well as lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors [1]

Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with Goldman Sachs, JPMorgan, and CITIC Securities as joint sponsors, while already being listed on the Shanghai Stock Exchange [1][4]. Company Overview - Baili Tianheng focuses on the global forefront of biomedicine, aiming to address unmet clinical needs, particularly in the field of tumor macromolecule therapy, and possesses leading innovative R&D capabilities [4][5]. - The company aims to become a multinational pharmaceutical company (MNC) with a sustained global leading position in oncology drugs, operating two main business segments: innovative biopharmaceuticals and generic drugs [4]. Product Development - The company established SystImmune in Seattle in 2014 and developed iza-bren (BL-B01D1), the world's first and only EGFR×HER3 bispecific ADC currently in Phase III clinical development [4]. - In 2024, Baili Tianheng entered into a strategic licensing and collaboration agreement with BMS for iza-bren, valued at $8.4 billion, marking the largest single asset transaction in the global ADC field [4]. Clinical Research and Pipeline - Baili Tianheng has developed a pipeline of nine ADC innovative candidates that have entered clinical stages, conducting approximately 70 clinical studies, including 16 key registration trials in China and 3 global key registration trials [5]. - The company has also developed a multi-specific T-cell connector platform and a potential first-in-class ARC drug, BL-ARC001, which has submitted an IND [5]. Financial Performance - For the fiscal years ending December 31, 2022, 2023, and the six months ending June 30, 2024, the company reported revenues of approximately RMB 702 million, RMB 560 million, and RMB 58.21 billion, respectively [7]. - The company experienced net losses of approximately RMB 2.82 billion, RMB 7.8 billion, and a projected profit of RMB 3.71 billion for the same periods, with the significant increase in 2024 attributed to an $800 million upfront payment from BMS [5][7].