Core Viewpoint - Huaxi Biological has successfully registered its fermentation-derived sodium chondroitin sulfate with the National Medical Products Administration, marking it as the first company in China to achieve compliance for this product [1][4] Company Announcements - Huaxi Biological's fermentation-derived sodium chondroitin sulfate has completed the main document registration for medical devices, allowing it to be used in Class II and III medical devices, potentially providing core materials for high-end medical equipment [1][4] - The controlling shareholder, Huaxi Xinyu Investment Co., Ltd., plans to increase its stake in Huaxi Biological by investing between RMB 200 million and RMB 300 million over the next six months, with a maximum purchase price of RMB 70 per share [3][4] Market Context - Traditional chondroitin sulfate is extracted from animal cartilage, which poses issues such as immunogenicity, unsustainable sourcing, and high pollution from extraction processes. The company aims to leverage synthetic biology technology to develop chondroitin sulfate raw materials for ophthalmology, orthopedics, and medical aesthetics [2]

Group 1 - The economic transformation and emerging industries are beginning to show potential, while risk-free returns are declining, establishing a move towards a "transformation bull market" [1][9] - The market is currently in a critical phase of contention between bulls and bears, with the possibility of breaking previous highs if favorable policies and increased market participation occur [9] - The banking sector is entering the mid-year reporting season, with expectations of better-than-expected interest margins and stable asset quality, which will support continued investment logic [9] Group 2 - Nine Ding Investment plans to acquire a 53.29% stake in Nanjing Shenyuan Intelligent Technology for 213 million yuan, aiming to expand its industrial layout and cultivate new growth points [9] - Huaxi Biological has successfully completed the registration of its fermentation method sodium chondroitin sulfate with the National Medical Products Administration, becoming the first company in China to achieve compliance for this product [11] - Changan Automobile and its indirect controlling shareholder plan to increase their holdings in the company by no less than 5.7 million yuan, indicating confidence in the company's future performance [12]

Group 1 - Beijing Beida Pharmaceutical's subsidiary, Beijing Beida Medicine, has suspended its main business since June 2025 due to the termination of a long-term service contract with Peking University International Hospital [1] - The termination reflects the subsidiary's weak business structure and inability to diversify its client base, which may lead to operational sustainability issues and potential personnel adjustments [1] - The parent company may experience short-term performance impacts as a result of this development [1] Group 2 - Huaxi Biological's fermentation-derived chondroitin sodium has successfully completed the main document registration with the National Medical Products Administration, marking it as the first compliant fermentation-derived chondroitin sodium in China [2] - This new pharmaceutical-grade raw material can be applied in Class II and III medical devices, potentially expanding the company's raw material business applications and serving as a new growth point for performance [2] - Future market expansion and downstream customer integration will be critical for the commercial success of this product [2] Group 3 - Tongrentang announced a change in leadership, with the resignation of Chairman Di Shubing and the election of Zhang Zhaohua as the new chairman [3] - This leadership change is part of normal internal rotation and may indicate a strategic management strengthening and business development push for the company [3] Group 4 - *ST Wuzhong has initiated arbitration against Regen Biotech, Inc. for breach of contract, with the Shenzhen International Arbitration Court accepting the case [4] - The arbitration seeks to confirm the validity of the exclusive agency agreement and may involve a preliminary claim for damages amounting to RMB 1.6 billion, covering various losses [4] - The outcome of this arbitration could significantly impact *ST Wuzhong's operational pressure and stock price, depending on the ruling [4] Group 5 - Rongchang Bio's RC148 has been proposed for inclusion in the breakthrough therapy designation program for treating advanced or metastatic non-small cell lung cancer [5] - This PD-1/VEGF dual antibody is the fourth of its kind to receive such designation, following competitors like Kangfang Biotech and Promis [5] - The competitive landscape for multi-target dual antibodies is intensifying, and Rongchang's progress may further drive technological advancements in the industry [5]

软骨素钠的业务拓展，未来受市场竞争格局变化、下游终端产品开发进度变 化及原有终端产品开展原料替换难度等因素影响，业务发展存在不确定性，提醒 广大投资者注意投资风险。 华熙生物科技股份有限公司（以下简称"公司"）自主研发的发酵法软骨素 钠原料（以下简称"软骨素钠"）成功通过国家药品监督管理局医疗器械技术审 评中心（CMDE）的主文档备案登记（登记号：M2025264-000），成为我国首 个实现发酵法软骨素钠合规化备案的企业。 本次完成备案的软骨素钠作为公司医药级原料的新品种，可应用于 II 类、III 类医疗器械，未来有望为高端医疗器械提供核心原料。 传统硫酸软骨素主要从动物软骨（如猪、牛、鸡、鲨鱼）中提取，存在动物 免疫原性、原料来源不可持续、提取工艺污染高等问题。下一步，公司将以发酵 法得到的软骨素钠为基础，利用合成生物学技术开发硫酸软骨素原料，应用于眼 科、骨科、医美等领域。 证券代码：688363 证券简称：华熙生物 公告编号：2025-029 华熙生物科技股份有限公司 关于发酵法软骨素钠完成医疗器械主文档登记的 自愿性披露公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者 ...

Core Points - Huaxi Biological announced the successful registration of its self-developed fermentation method sodium chondroitin sulfate with the National Medical Products Administration (NMPA) [1] - The registered sodium chondroitin sulfate is a new type of pharmaceutical-grade raw material that can be applied in Class II and Class III medical devices [1]

北京商报讯（记者 丁宁）8月11日晚间，华熙生物（688363）发布公告称，公司自主研发的发酵法软骨 素钠原料（以下简称"软骨素钠"）成功通过国家药品监督管理局医疗器械技术审评中心的主文档备案登 记，成为我国首个实现发酵法软骨素钠合规化备案的企业。 华熙生物表示，本次完成备案的软骨素钠作为公司医药级原料的新品种，可应用于II类、III类医疗器 械，未来有望为高端医疗器械提供核心原料。 据悉，传统硫酸软骨素主要从动物软骨（如猪、牛、鸡、鲨鱼）中提取，存在动物免疫原性、原料来源 不可持续、提取工艺污染高等问题。华熙生物表示，下一步，公司将以发酵法得到的软骨素钠为基础， 利用合成生物学技术开发硫酸软骨素原料，应用于眼科、骨科、医美等领域。 ...