2025 年 12 月 14 日 生物医药Ⅱ 新药周观点 ： 国内多个企业布局 INHBE siRNA，减脂不减肌值得期待 本周新药行情回顾： 2025 年 12 月 8 日-2025 年 12 月 14 日，新药板块涨幅前 5：圣诺医 药（+30.88%）、东曜药业（+16.37%）、海创药业（+13.91%）、益方 生物（+11.29%）、加科思（+10.56%）；跌幅前 5：科济药业（- 14.19%）、荣昌生物（-10.09%）、乐普生物（-9.18%）、海思科（- 9.12%）、再鼎医药（-8.39%）。 本周建议关注标的： 考虑板块后续仍有多个催化值得期待，包括学术会议、数据读出、 多个 BD 兑现等，仍建议关注： 1）已获 MNC 认证未来海外放量确定性高的品种：三生制药、联邦制 药、科伦博泰等； 2）存在海外数据催化的品种：贝达药业、和黄医药、映恩生物等； 3）下一个可能海外授权 MNC 的重磅品种：复宏汉霖、石药集团、益 方生物等； 目前全球已有多家公司布局靶向 INHBE 的 siRNA 药物，其中 5 款药 物已进入临床开发阶段；此外国内企业也已积极布局这一领域，包 括大睿生物、圣因生物 ...

消息面上，12月11日，诺诚健发布公告，国家药品监督管理局(NMPA)已批准第二代小分子泛原肌球蛋 白相关激酶抑制剂(泛TRK抑制剂)佐来曲替尼(ICP-723)，用于治疗携带NTRK融合基因的成人和12岁以 上青少年实体瘤患者。佐来曲替尼已被NMPA纳入"星光计划"，该计划是一项为鼓励儿童抗肿瘤药物研 发而开展的试点项目。本公司预计不久将递交佐来曲替尼治疗儿童患者(2岁至12岁)的新药上市申请 (NDA)。 NTRK融合基因存在于各种类型的肿瘤，目前已在超过26种实体瘤中发现了NTRK融合基因。中国每年 新发的携带NTRK融合基因的肿瘤人群预估约6,500例，这些患者通常生存期短、疾病进展快、致残率 高，而由于目前金标准检测方法—下一代测序(NGS)的普及率较低，导致诊断延迟，因此仍存在未被满 足的临床需求。 智通财经APP获悉，诺诚健华(09969)涨超3%，截至发稿，涨3.24%，报14港元，成交额5105.45万港 元。 ...

鲁抗医药：向两家全资子公司增资 12月12日，鲁抗医药（600789）发布公告称，拟向其全资子公司生物农药公司增资1.09亿元，向泽润公 司增资2700万元。增资完成后，生物农药公司的注册资本将由4125万元增加至1.5亿元，泽润公司的注 册资本将由300万元增加至3000万元。此次增资旨在推进公司农药板块及销售板块的扩展，满足业务拓 展需求。 汇绿生态：拟1252万元出售宁波两处房产 12月12日，汇绿生态（001267）发布公告称，为优化资产结构、提高资产使用效率，公司董事会审议通 过议案，拟将位于宁波市鄞州区的两套合计805.86平方米的独栋办公用房出售给宁波伊玛环境科技股份 有限公司，出售价格为1252万元。经初步测算，该交易预计对公司当期净利润的影响约为622.76万元。 天原股份：子公司拟1.85亿元实施钛白粉装置智能化提升项目 12月12日，天原股份（002386）发布公告称，全资子公司宜宾天原海丰和泰有限公司（简称"海丰和 泰"）拟投资钛白粉装置智能化提升项目，对海丰和泰一期、二期钛白粉生产线、综合资源利用及公用 工程实施装置自动化与控制自动化改造。项目主要内容包括：全流程自动化升级、生产运营 ...

转自：新华财经 •中央经济工作会议在北京举行 会议指出推动投资止跌回稳 适当增加中央预算内投资规模 •前11月我国汽车产销量双超3100万辆同比增逾10% 11月产量首超350万辆创历史新高 •商务部：推动安世荷兰尽快派员来华 就企业控制权和恢复供应链稳定与畅通开展协商 •中央经济工作会议12月10日至11日在北京举行。会议提出，坚持内需主导，建设强大国内市场。深入实施提振消费专项行动，制定实施城乡居民增收计 划。扩大优质商品和服务供给。优化"两新"政策实施。清理消费领域不合理限制措施，释放服务消费潜力。推动投资止跌回稳，适当增加中央预算内投资规 模，优化实施"两重"项目，优化地方政府专项债券用途管理，继续发挥新型政策性金融工具作用，有效激发民间投资活力。高质量推进城市更新。（新华 社） •最新数据显示，11月份，我国汽车月度产量首次超过350万辆，创历史新高。不仅如此，今年前11个月，汽车产销量均超过3100万辆，同比增长均超过 10%。中国汽车工业协会的最新数据同时显示，今年1至11月，我国新能源汽车产销量均接近1500万辆，同比增长均超过30%。在出口方面，新能源汽车出 口231.5万辆，同比增长1倍。 ...

Group 1: Company Announcements - 蓝盾光电 announced the termination of the equity transfer agreement with Shanghai Xingsi Semiconductor, with no payment made for the equity transfer [1] - 兆新股份 plans to acquire 70% of Youde New Energy for a maximum price of 220 million yuan, enhancing its capabilities in the renewable energy operation sector [2] - 南都电源 is in the process of planning a change in control and has suspended its stock trading, with the suspension expected to last no more than two trading days [3] - 万科A reported a guarantee balance of 84.476 billion yuan as of October 31, with no overdue guarantee matters [4] - 国晟科技's stock price has increased significantly, with a cumulative rise of 206.62%, indicating potential irrational speculation and risks of a rapid price drop [5] - 中威电子 announced a change in its actual controller to Fu Yingbo, with stock trading set to resume [6] Group 2: Mergers and Acquisitions - 新兴铸管's subsidiary plans to acquire 100% of China Resources Steel for 1.244 billion yuan [7] Group 3: Share Transfers and Investments - 太龙药业's shareholder plans to transfer 50.1 million shares to Jiangyao Holdings [8] - 医药 approvals include 常山药业 receiving a drug registration certificate for heparin sodium injection in Turkmenistan [9] - 真兰仪表's shareholder intends to increase holdings by 10 to 20 million yuan [9] - 海南瑞泽's vice president plans to reduce holdings by 231,000 shares [9] - 金陵体育's director has reduced holdings by 0.0276% [9] - 佰仁医疗's subsidiary has received approval for a collagen implant product [9]

格隆汇12月11日丨诺诚健华(09969.HK)宣布，国家药品监督管理局(NMPA)已批准第二代小分子泛原肌 球蛋白相关激酶抑制剂(泛TRK抑制剂)佐来曲替尼(ICP-723)，用于治疗携带NTRK融合基因的成人和12 岁以上青少年实体瘤患者。 在针对NTRK融合阳性的实体瘤患者的注册临床试验中，佐来曲替尼展示出卓越的有效性和良好的安全 性。研究结果显示客观缓解率(ORR)达89.1%，疾病控制率(DCR)为96.4%，24个月无进展生存(PFS)率为 77.4%，24个月总生存(OS)率为90.8%。 作为新一代TRK抑制剂，佐来曲替尼的疗效优于第一代TRK抑制剂，不仅能够带来长期深度缓解且药物 透脑活性强、整体安全性良好，同时有数据显示能够克服第一代TRK抑制剂的耐药性。佐来曲替尼每天 一次、每次两片的口服给药方式，也为患者带来很大的便利性。 佐来曲替尼已被NMPA纳入「星光计划」，该计划是一项为鼓励儿童抗肿瘤药物研发而开展的试点项 目。公司预计不久将递交佐来曲替尼治疗儿童患者(2岁至12岁)的新药上市申请(NDA)。 NTRK融合基因存在于各种类型的肿瘤，目前已在超过26种实体瘤中发现了NTRK融合基因 ...

智通财经APP讯，诺诚健华(09969)发布公告，国家药品监督管理局(NMPA)已批准第二代小分子泛原肌 球蛋白相关激酶抑制剂(泛TRK抑制剂)佐来曲替尼(ICP-723)，用于治疗携带NTRK融合基因的成人和12 岁以上青少年实体瘤患者。 佐来曲替尼已被NMPA纳入"星光计划"，该计划是一项为鼓励儿童抗肿瘤药物研发而开展的试点项目。 本公司预计不久将递交佐来曲替尼治疗儿童患者(2 岁至12岁)的新药上市申请(NDA)。 NTRK融合基因存在于各种类型的肿瘤，目前已在超过26种实体瘤中发现了 NTRK融合基因。中国每年 新发的携带NTRK融合基因的肿瘤人群预估约6,500 例，这些患者通常生存期短、疾病进展快、致残率 高，而由于目前金标准检测方法 — 下一代测序(NGS)的普及率较低，导致诊断延迟，因此仍存在未被 满足的临床需求。 作为新一代TRK抑制剂，佐来曲替尼的疗效优于第一代TRK抑制剂，不仅能够带来长期深度缓解且药物 透脑活性强、整体安全性良好，同时有数据显示能够克服第一代TRK抑制剂的耐药性。佐来曲替尼每天 一次、每次两片的口服给药方式，也为患者带来很大的便利性。 在针对NTRK融合阳性的实体瘤患者 ...

Core Insights - The collaboration between Innovent Biologics and Zenas for three self-immune pipeline products marks a significant milestone in the internationalization of the drug Orelabrutinib and sets a new record for small molecule transactions in China's self-immune field, with a total potential transaction value exceeding $2 billion [1] - The development of the first-class new drug HH-003 (Libevev) by Huahui Anjian, targeting chronic hepatitis D, is expected to receive approval for market launch around the first quarter of 2026, representing a major milestone in the company's growth [2][3] Company Developments - Huahui Anjian has been developing HH-003 since its inception, with significant funding rounds supporting its clinical trials, including a recent A++ round financing and breakthrough therapy designation from the FDA for treating chronic hepatitis D [3][4] - The drug HH-003 has shown promising results in clinical trials, demonstrating good safety and antiviral activity, with a notable decrease in HBV DNA and hepatitis B surface antigen levels observed in patients [3][4] Industry Context - The Zhongguancun Life Science Park, where both Innovent Biologics and Huahui Anjian are based, is a key area for biotechnology innovation in Beijing, having produced significant drugs like Orelabrutinib and Zebutinib [1][5] - The park is recognized for its comprehensive industry chain, facilitating the transition from laboratory research to clinical application, thus fostering a competitive pharmaceutical health industry [10] Product Pipeline and Market Potential - Innovent Biologics has developed Orelabrutinib, a BTK inhibitor that has been approved in China and Singapore, with plans for further clinical trials targeting multiple sclerosis [6][7] - The company is also advancing its pipeline with a new generation TRK inhibitor, demonstrating a strategic focus on expanding its product offerings in oncology and autoimmune diseases [7][8] Competitive Landscape - The competitive landscape for BTK inhibitors in China includes several products, with Orelabrutinib positioned to capture market share due to its rapid development and broad application potential [6] - WanTai Biologics, another company in the park, is expanding its vaccine pipeline, including the world's first marketed hepatitis E vaccine, showcasing the diverse innovation occurring within the Zhongguancun Life Science Park [9][10]

Core Insights - Nocera Biopharma's new pan-TRK inhibitor, zurletrectinib (ICP-723), has been included in China's National Medical Products Administration (NMPA) "Star Program" for pediatric oncology drug development [1][2] - The new drug application (NDA) for zurletrectinib targeting adult and adolescent patients with NTRK fusion gene-positive advanced solid tumors has been accepted in China and is under priority review [1] - Clinical trials for zurletrectinib in children aged 2 to 12 years are ongoing, with plans to submit the NDA by the second half of 2025 [1] Company and Industry Summary - The "Star Program" aims to enhance communication between drug applicants and the NMPA to improve the efficiency of pediatric oncology drug development [2] - Nocera Biopharma's CEO highlighted the prevalence of NTRK gene fusion in pediatric tumors and emphasized the recognition of the company's innovation capabilities through the inclusion of zurletrectinib in the program [2] - The clinical trials for zurletrectinib have demonstrated excellent efficacy and safety, overcoming resistance seen with first-generation TRK inhibitors [1]

Core Viewpoint - The company, Innovent Biologics, reported a significant revenue increase driven by the continued growth of its core product, Oubatinib, and strategic partnerships, while also making substantial progress in its clinical pipeline and global expansion efforts [1][3][4]. Financial Performance - For the first half of 2025, the company's revenue grew by 74.3% year-on-year, reaching 730 million RMB, primarily due to the strong sales of Oubatinib and an upfront payment from a licensing agreement with Prolium [1]. - Drug revenue increased by 53.5% year-on-year to 640 million RMB, attributed to Oubatinib's inclusion in the national medical insurance and its expanding patient base [1]. - The company's loss narrowed by 86.7% year-on-year to 36 million RMB, reflecting increased revenue and improved cost efficiency [1]. Research and Development - R&D expenses rose by 6.9% year-on-year to 450 million RMB, focusing on building a differentiated R&D platform and advancing multiple Phase III clinical projects [1][2]. Product Pipeline and Approvals - Oubatinib was approved for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and is included as a Level I recommendation in the CSCO lymphoma treatment guidelines [3]. - Tafasitamab (brand name: Mingnuokai) was approved for treating relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in combination with lenalidomide, marking it as the first CD19 monoclonal antibody approved for this indication in China [3]. - The BCL2 inhibitor, Mesutoclax (ICP-248), is advancing in two registration clinical studies and has received Breakthrough Therapy Designation, being the first BCL2 inhibitor in China to achieve this status [3]. - The new generation TRK inhibitor, Zurletrectinib (ICP-723), has had its new drug application accepted in China and is under priority review, potentially becoming the first domestically developed TRK inhibitor approved for market [3]. Strategic Partnerships and Global Expansion - The company is expanding its global footprint through strategic collaborations, including a licensing agreement with Prolium for the development and commercialization of the CD20×CD3 bispecific antibody ICP-B02 [4]. - The commercial team has shown strong execution capabilities, leading to increased market penetration and revenue growth for Oubatinib [4]. Leadership in Hematological Oncology - The company is strengthening its leadership position in hematological oncology with Oubatinib, Tafasitamab, and Mesutoclax as cornerstone therapies [5]. - Oubatinib's approval for first-line treatment of CLL/SLL and Tafasitamab's approval for R/R DLBCL enhance the company's product offerings in this field [5]. Autoimmune Disease Pipeline - Oubatinib is being developed as a new treatment option for primary immune thrombocytopenia (ITP), with Phase III clinical trials completed and an application for market approval expected in mid-2026 [11]. - The company is also advancing two TYK2 inhibitors in clinical trials, targeting various autoimmune diseases [12]. ADC Technology Development - The company has developed a differentiated ADC technology platform aimed at creating effective and targeted therapies for cancer treatment [16]. - The first ADC candidate, targeting B7-H3, has received clinical approval and is expected to enter patient trials soon [18][19].