On April 30th, the National Health Commission issued the "Guiding Opinions on Optimizing the Layout and Construction of Grassroots Medical and Health Institutions", once again clarifying the need to expand the types of drugs used for common and chronic diseases at the grassroots level, and promote the unification of drug catalogs for county-level medical communities.

The Opinion guides various regions to comprehensively coordinate the development of urban-rural integration, changes in population structure, and public health needs, and to improve the layout and construction of grassroots medical and health institutions according to local conditions. This is in line with the State Council executive meeting's proposal to "improve the construction layout according to local conditions". The core goal of the policy is to optimize resource allocation and improve service capabilities, promote the implementation of tiered diagnosis and treatment, and achieve a medical pattern of "minor illnesses not leaving the village and major illnesses not leaving the county".

21 Comment: In mid April this year, Zhang Feng, Director of the Drug Department of the National Health Commission, and his delegation visited Guangxi to investigate grassroots drug supply guarantee work. They emphasized the need to base on local advantages, play a good role in horizontal and vertical linkage, optimize drug catalog management, and standardize and expand the types of drugs used for chronic and common diseases.

According to publicly available information, provinces such as Henan, Anhui, and Gansu have requested to complete directory optimization and adjustment work by the end of April, while some provinces have set a deadline of the end of May or June.

Hunan Provincial Medical Insurance Bureau issues document to further standardize the management of shortage drugs

Recently, the Hunan Provincial Medical Security Bureau issued a notice on further standardizing the risk management of shortage drug prices and online procurement (hereinafter referred to as the "Notice"), which provides clear requirements on how to optimize management.

The Notice specifies that the provincial centralized procurement institutions for pharmaceuticals shall strictly follow relevant procedures and policy regulations to handle the online application and acceptance of shortage drugs, and regularly analyze the supply guarantee and transaction price situation of shortage drugs in our province. Medical insurance departments at all levels should timely grasp and accept the demand for shortage of drugs and supplies in local medical institutions, coordinate and handle it in a timely manner, and ensure stable supply of drugs that are prone to shortage.

Medical device approval

Johnson&Johnson FcRn monoclonal antibody approved for market launch

On April 30th, Johnson&Johnson announced that nivalizumab has been approved by the FDA for the treatment of systemic myasthenia gravis in adolescents and adults aged 12 and above who are positive for autoantibodies.

Nikelimab is an IgG1 monoclonal antibody that targets FcRn. In August 2020, Johnson&Johnson acquired Momenta for $6.5 billion and obtained this drug. Previously, two FcRn monoclonal antibodies have been approved by the FDA for marketing worldwide, namely Argenx/Zaiding's Egamade alpha and Ushibi's Rozerilizumab.

Shiyao Group's JMT202 has been approved for clinical trials in the United States

The announcement from Shiyao Group shows that its developed recombinant whole human anti - β Klotho monoclonal antibody drug JMT202 has been approved by the US Food and Drug Administration (FDA) and can be used for clinical research in the United States. The product was also approved by the China National Medical Products Administration in May 2024 and is currently undergoing clinical trials in China. The clinical indication approved this time is hypertriglyceridemia (HTG).

FDA accepts new drug application for semaglutide

Novo Nordisk recently announced that the US FDA has accepted a new drug application (NDA) for Wegovy (semaglutide) once daily, 25 mg oral dosage form, intended for long-term weight management in overweight adults with obesity or one or more comorbidities, as well as for reducing the risk of major adverse cardiovascular events (MACEs) in adult patients with obesity or overweight cardiovascular disease. The press release states that if approved, Wegovy will become the first oral glucagon like peptide-1 (GLP-1) formulation for long-term weight management. The FDA expects to complete the review of this new drug application in the fourth quarter of 2025.

Financial report disclosure

Baiyun Mountain's net profit for the first quarter of 2025 decreased by 6.99% year-on-year

On April 30th, Baiyun Mountain released its first quarter report for 2025, which showed that the company's total operating revenue was 22.473 billion yuan, a year-on-year decrease of 2.06%. The net profit attributable to the parent company was 1.821 billion yuan, a year-on-year decrease of 6.99%.

Xinhua Medical's net profit for the first quarter of 2025 decreased by 23.97% year-on-year

On April 30th, Xinhua Medical released its first quarter report for 2025, which showed that the company's total operating revenue was 2.308 billion yuan, a year-on-year decrease of 8.74%. The net profit attributable to the parent company was 160 million yuan, a year-on-year decrease of 23.97%.

Meanwhile, Xinhua Medical released its 2024 performance report, showing a total operating revenue of 10.021 billion yuan, an increase of 0.09% compared to the same period last year. The net profit attributable to the parent company was 692 million yuan, an increase of 5.75% compared to the same period last year.

capital market

Fosun Pharma and Sandoz have reached an authorized cooperation on ipilimumab biosimilars, with a total amount exceeding 300 million US dollars

On April 29th, Fosun Pharma announced that it has reached an authorization cooperation agreement with Sandoz (SIX: SDZ/OTCXX: SDZNY), a global leader in the field of generic drugs and biosimilars, granting the latter exclusive commercialization rights for the company's independently developed ipilimumab biosimilar HLX13 (anti-CTLA-4 monoclonal antibody) in 42 countries and regions in the United States, Europe, Japan, Canada, and Australia.

According to the terms of the agreement, Fosun Pharma will be responsible for the research and development, production, and commercial supply of HLX13, and will generate potential revenue of $301 million from the transaction, of which $31 million is the down payment.

Industry Events

Investing 6 billion yuan, private hospitals continue to expand

Recently, the Beijing United Family International Hospital project announced the launch of its planning. The hospital will be located in Dongfeng Township, Chaoyang District, with 600 beds and is expected to be put into operation in 2029. It is reported that the total investment of the hospital will reach 6 billion yuan, and after completion, it will become an international tertiary comprehensive hospital and research base integrating medical treatment, teaching, and scientific research.

21 Comment: In the past decade, private hospitals in China have rapidly expanded. In 2015, the number of private hospitals in China exceeded that of public hospitals; In 2021, the number of private hospitals reached twice that of public hospitals for the first time; By 2023, the number of private hospitals in China will reach 26000, more than double that of 10 years ago. With the sweeping waves of industry change, the remaining private hospitals may have found a clearer and more sustainable development path.

Xinda Biotech announces the completion of the world's first CEACAM5 dual load ADC (IBI3020) in Phase I clinical trials, with the first subject receiving medication

On April 30th, Xinda Biotechnology announced that its independently developed dual load ADC (R&D code: IBI3020) targeting CEACAM5 had completed the first subject administration in phase I clinical trials. This is the DuetTx ADC platform independently developed by Xinda Biotech ® The first dual load ADC produced on the platform is also the first dual load ADC of its kind known worldwide to complete clinical patient administration.

Public opinion warning

Suspected of monopoly, multiple pharmaceutical companies fined

On May 5th, Xianju Pharmaceutical announced that the company received an "Administrative Penalty Decision" issued by the Tianjin Municipal Market Supervision and Administration Commission on April 30th, and was fined a total of 195 million yuan.

The Tianjin Municipal Market Supervision and Administration Commission believes that Xianju Pharmaceutical and other operators with competitive relationships have changed or fixed the price of dexamethasone sodium phosphate raw materials in the form of monopoly agreements, excluding and restricting competition in the sales field of dexamethasone sodium phosphate raw materials. This violates the relevant provisions of the Anti Monopoly Law of the People's Republic of China and constitutes an act of reaching and implementing a "fixed or changed commodity price" monopoly agreement, and should be held legally responsible in accordance with the law. Chairman Zhang Yusong, as the main person in charge, bears personal responsibility.

On April 30th, Jinyao Pharmaceutical and Lianhuan Pharmaceutical were also ordered by the Tianjin Municipal Market Supervision and Administration Commission to stop their illegal activities due to the same matter, and were fined 69.1924 million yuan and 61.0382 million yuan respectively.

The actual controller and chairman of Yong'an Pharmaceutical are detained

On May 6th, Yong'an Pharmaceutical announced that it had received a notice from the family of Mr. Chen Yong, the actual controller and chairman of the company. Recently, it received the "Notice of Filing" and "Notice of Detention" issued by the Hefeng County Supervision Committee regarding Mr. Chen Yong. Mr. Chen Yong, the actual controller and chairman of the company, has been investigated and detained.

Yong'an Pharmaceutical stated that the company has made appropriate arrangements for the relevant work at present.

Ha Sanlian and related personnel received a warning letter from Heilongjiang Securities Regulatory Bureau

On May 6th, Harbin Sanlian Pharmaceutical Co., Ltd. announced that it had received the "Decision on Issuing Warning Letters for Harbin Sanlian Pharmaceutical Co., Ltd., Qin Jianfei, Zhao Zhicheng, and Liang Yanfei" issued by the Heilongjiang Regulatory Bureau of the China Securities Regulatory Commission on April 30th, 2025.

The "Warning Letter" shows that from July 2022 to July 2023, the relevant matters constituted external financial assistance from Harbin Sanlian. The company failed to fulfill the corresponding review procedures and information disclosure obligations in accordance with regulations, violating Article 3, Paragraph 1 of the "Measures for the Administration of Information Disclosure of Listed Companies" (CSRC Order No. 182) and Article 6.1.9 of the "Shenzhen Stock Exchange Listing Rules" (revised in 2022, 2023, and August 2023). At the same time, Qin Jianfei, Chairman and General Manager of the company and then Secretary of the Board of Directors, Zhao Zhicheng, Chief Financial Officer, and Liang Yanfei, Secretary of the Board of Directors, failed to fulfill their diligent and responsible obligations in accordance with Article 4 of the Measures for the Administration of Information Disclosure of Listed Companies (CSRC Order No. 182), and bear the main responsibility for the above-mentioned violations of the company.