Develop and issue a catalog of innovative drugs for commercial health insurance; Huahai Pharmaceutical receives FDA warning letter

June 11, 2025  Source: drugdu 52

 

Central Office and State Office: Improve the adjustment mechanism of the basic medical insurance drug catalog, formulate and introduce the innovative drug catalog for commercial health insurance

On June 9th, the General Office of the Communist Party of China and the General Office of the State Council issued the "Opinions on Further Ensuring and Improving People's Livelihood and Focusing on Solving the Urgent Difficulties and Worries of the Masses". Promote the sharing of high-quality medical and health resources. Promote the expansion and sinking of high-quality medical resources and balanced regional layout, optimize the construction mode, management system, and operation mechanism of regional medical centers. Implement the medical and health infrastructure project, promote the sinking of urban medical resources to county-level hospitals and urban and rural grassroots, and gradually achieve full coverage of the construction of a close county-level medical community. Support high-level hospital personnel, services, technology, management, etc. to sink to grassroots medical and health institutions, and promote the construction of urban medical consortia. Support high-level medical talents to sink to county-level hospitals, focus on strengthening the construction of weak specialties in grassroots medical and health institutions, cultivate and run characteristic specialties at the grassroots level according to local conditions, improve the diagnosis and treatment level of common and frequently occurring diseases, and promote the improvement of service capabilities of grassroots medical and health institutions. Promote the establishment of a remote medical service network and promote the "distributed examination, centralized diagnosis" medical service model. Improve the adjustment mechanism of the basic medical insurance drug catalog, formulate and issue an innovative drug catalog for commercial health insurance, and better meet the multi-level medication protection needs of the people.

Comment 21: In China's multi-level medical security system, commercial health insurance plays an important role outside of medical insurance and has become an indispensable part. In recent years, its development trend has been strong, with continuous expansion of business scale and continuous improvement of service capabilities, providing diversified health protection for the people. The commercial insurance catalog is currently becoming a key lever to promote the high-quality development of commercial health insurance. At the same time, commercial health insurance can to some extent break the payment dilemma of innovative drugs and help promote the development of innovative drugs. Although there are still some policy bottlenecks at present, the pace of resolving related issues is accelerating.

Beijing: Support a batch of robots to be tested and used for the first time in education, healthcare, elderly care and other scenarios

On June 9th, the Beijing Municipal Bureau of Economy and Information Technology and five other departments issued the "Implementation Plan for High Quality Development of the Fashion Industry in Beijing (2025-2027)", which proposes to encourage the creation of immersive experiences that are "observable, playable, and purchasable", expand consumption scenarios such as brand physical stores, intangible cultural heritage exhibition halls, technology interactive exhibition areas, and historical and cultural districts, create a new retail model that integrates product recognition, brand display, and deep experience, activate product consumption momentum, and enhance product premium ability. Create creative markets in commercial districts, scenic spots, cultural industry parks, etc., enrich consumer goods supply scenarios, and meet creative, personalized, and emotional consumption needs. Support a batch of robots to be tested and used for the first time in education, healthcare, elderly care and other scenarios, accelerate product development iteration, and expand the robot after-sales service market.

Medical device approval

Daan Gene has obtained registration certificates for six respiratory pathogen nucleic acid testing kits and medical devices

On June 9th, Daan Gene (002030. SZ) announced that the company has recently obtained a medical device registration certificate issued by the National Medical Products Administration, specifically for six respiratory pathogen nucleic acid detection kits (PCR fluorescence probe method), with registration certificate number: National Medical Device Registration Standard 20253401117. Valid until June 5th, 2030. This product is used for qualitative detection of six respiratory pathogen nucleic acids in throat swabs of the population, including respiratory syncytial virus, human bocavirus, adenovirus, rhinovirus, Chlamydia pneumoniae, and Mycoplasma pneumoniae. The acquisition of the medical device registration certificate has enriched the company's product portfolio and expanded the application areas of its products. At present, the product is still in the market development stage, and there is uncertainty in market demand. Investors are advised to pay attention to investment risks.

Bohui Innovation obtains medical device registration certificate

On June 9th, Bohui Innovation (300318. SZ) announced that the company has recently obtained the "Medical Device Registration Certificate (In Vitro Diagnostic Reagent) of the People's Republic of China" issued by the National Medical Products Administration. The product name is Human Papillomavirus Genotyping (Type 28) Detection Kit (Chip Hybridization Method), and the registration classification is Class III.

Shanghai Pharmaceuticals: Fumarate Fumatrol Inhalation Solution Approved for Production

On June 9th, Shanghai Pharmaceutical (601607. SH) announced that its subsidiary Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd.'s fumarate formoterol inhalation solution has received a "Drug Registration Certificate" issued by the National Medical Products Administration, and the drug has been approved for production. This drug is used for maintenance treatment of airway obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. As of the announcement date, the company has invested approximately 4.4055 million yuan in research and development expenses for this drug.

capital market

Pailin Biotechnology: China Biologics acquires 21.03% of the company's shares and resumes trading

On June 9th, Pailin Biotechnology (000403. SZ) announced that the company's stock will resume trading from June 10th, 2025. The controlling shareholder of the company, Shengbang Yinghao, has signed an acquisition framework agreement with China Biology, intending to transfer 21.03% of the company's shares to China Biology. If the transaction is successfully completed, the controlling shareholder of the company will be changed from Shengbang Yinghao to China Biology, and the actual controller will be changed from Shaanxi Provincial State owned Assets Supervision and Administration Commission to China National Pharmaceutical Group Co., Ltd. However, there is still uncertainty regarding this matter, including the uncertain signing time of subsequent agreements, the risk of failure to sign and complete transactions, as well as the uncertainty of whether it can be ultimately implemented and the results of implementation.

CGN: Controlling shareholder increases capital of 500 million yuan to wholly-owned subsidiary for proton medical research and development

On June 9th, CGN Technology (000881. SZ) announced that its controlling shareholder, CGN Nuclear Technology Application Co., Ltd., plans to increase its capital by 500 million yuan in cash to its wholly-owned subsidiary, CGN Medical Technology (Mianyang) Co., Ltd., for proton medical research and development projects and future business development. After the capital increase is completed, the nuclear technology company will hold 44.13% of the equity of the medical technology company, and the company will hold 55.87% of the equity. The medical technology company will still be a controlling subsidiary of the company. This transaction constitutes a related party transaction and has been reviewed by the company's board of directors. It still needs to be submitted to the shareholders' meeting for review.

Zhonghui Pharmaceutical has completed two rounds of financing worth tens of millions of yuan

On June 9th, Shaanxi Yungu Zhonghui Biopharmaceutical Co., Ltd. completed nearly 50 million yuan in seed and angel round financing. The seed round financing was jointly invested by Xincheng Investment and Aikang Chuangtan, while the angel round financing was jointly invested by Shaanxi Investment Growth Fund, Zhongke Chuangxing, and Jinzi Fund. At the same time, Zhonghui Pharmaceutical announced the completion of the merger and reorganization of Shanghai Lanwei Medical Technology Co., Ltd. The new round of financing will be used for the construction of China's first hollow microneedle medical device production base, the application for Class III device certificates, the construction of cell and extracellular vesicle pilot workshops, the construction of the first automated biological tissue sample bank in Northwest China, and the improvement of the talent team.

Industry Events

Dongxing Medical: Holding subsidiary signs two synthetic biology technology development contracts with Shanghai Jiao Tong University

On June 9th, Dongxing Medical (301290. SZ) announced that its holding subsidiary Changzhou Dongxing Biopharmaceutical Co., Ltd. had signed a "Technology Development (Entrustment) Contract" with Shanghai Jiao Tong University, with a total contract amount of 6 million yuan. Project 1: Development of Preparation Process for Truncated (Short Chain) Recombinant Type III Humanized Collagen Protein; Project 2 is the development of a process for preparing full-length (long-chain) recombinant type III humanized collagen protein. The ownership of the relevant invention patents applied for by Dongxing Biotechnology with the assistance of Shanghai Jiao Tong University belongs to Dongxing Biotechnology, and Shanghai Jiao Tong University enjoys the right of attribution. The cooperation between Dongxing Biotechnology and Shanghai Jiao Tong University this time is conducive to leveraging the cutting-edge research and development advantages of Shanghai Jiao Tong University in synthetic biology, enhancing the company's research and development technology and core achievement transformation capabilities, and forming sustainable technological innovation and product research and development capabilities.

Public opinion warning

Huahai Pharmaceutical receives FDA warning letter

On June 9th, Huahai Pharmaceutical (600521. SH) announced that the company had recently received a warning letter from the US Food and Drug Administration (FDA), which was based on an on-site inspection conducted by the FDA on the company's drug production base located in Xunqiao Town, Linhai City from January 16th to January 24th, 2025. The warning letter proposes relevant inspection opinions and improvement suggestions for the formulation products at the Xunqiao production base, mainly involving the adequacy of cleaning management of some oral solid production equipment, maintenance of sterile production areas, and research on tablet rejection parameters. This warning letter only affects the approval of ANDA new or supplementary applications related to the Xunqiao production base and will not have a significant impact on the company's current performance.

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