Multiple Originator Drugs Withdrawn from Market; Sanofi Invests €1 Billion in Beijing; Hospital Reimbursement Accelerates

This week, the pharmaceutical industry's first three-quarter report was released. CDMO company Jiuzhou Pharma achieved a revenue of 4.161 billion yuan in the first three quarters, representing a year-on-year increase of 4.92%; the net profit attributable to shareholders of the listed company was 748 million yuan, increasing by 18.51% year-on-year. In particular, in the third quarter, it realized a revenue of 1.29 billion yuan, growing by 7.37% year-on-year.Net profit attributable to shareholders of the listed company was 222 million yuan, representing a year-on-year increase of 42.30%.

On October 15, according to the official website of the NMPA, the National Medical Products Administration decided to cancel the registration certificates of 80 drugs, including loratadine tablets.Many of these varieties were voluntarily deregistered by the original research enterprises.Such as Xian Janssen's hemorrhoid medicine "Titanoreine Suppositories", which was previously reported to have increased in price more than 20 times. The drug has been discontinued since November 2023 due to the raw material, compound carrageenate, being naturally extracted and non-renewable.Currently, there is no raw material supply available globally.The product can only be withdrawn from the market.

For more information, Jianshi Bureau has compiled as follows:

1. The National Healthcare Security Administration Issues Document to Promote Immediate Settlement of Medical Insurance Funds

On October 16, the "Notice on Comprehensively Promoting the Expansion and Quality Improvement of Immediate Settlement Reform for Medical Insurance Funds" emphasized,By the end of 2025, all coordinated regions in China must implement real-time settlement.By the end of 2026, ensure that real-time settlement funds account for more than 80% of the local medical insurance fund’s monthly settlement funds; by the end of 2026, the proportion of designated medical institutions with real-time settlement activated will reach over 80%.

2. Due to Quality Issues, Shanghai Suspends Procurement of 2 Varieties

On October 14, the Shanghai Sunshine Pharmaceutical Procurement Network issued the "Notice on Suspending the Procurement Qualification of Certain Drugs."Suspend the procurement eligibility for two products: Shan Hai Dan Granules and Seven-Dimensional Taurine Oral Solution.The manufacturers are Zhejiang Shiqiang Pharmaceutical and Guizhou Fande Pharmaceutical.

According to the "Shanghai Municipal Drug Administration Announcement on the 3rd Issue of Drug Quality Sampling Inspection in 2025 (Shanghai Drug Administration Announcement [2025] No. 25)," a total of 10 batches of products were found to be non-compliant, involving four varieties: Albiziae Semen, Coenzyme Q10 Capsules, Shanhaidan Granules, and Seven-Vitamin Taurine Oral Solution.

3. 80 Drug Approval Numbers Revoked

On October 15, according to the latest announcement on the NMPA official website, in accordance with the relevant provisions of the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" and the "Measures for Drug Registration," the National Medical Products Administration has decided to cancel the registration certificates of 80 drugs, including loratadine tablets.All are "cancellation upon application."Involving multiple pharmaceutical companies such as Taicang Pharmaceutical, Hainan Shuangcheng Pharmaceutical, Jinling Pharmaceutical, and Hengrui Medicine.

Among them, Taicang Pharmaceutical Factory has the largest number of cancelled approvals, including isoniazid tablets, compound reserpine tablets, flunarizine tablets, phenylbutazone tablets, nefopam hydrochloride tablets, metronidazole tablets, inosine tablets, berberine hydrochloride tablets, perphenazine tablets, and vitamin B2 tablets. Notably,The number of product specifications from foreign enterprises involved reaches 44.Pfizer, Sandoz, Merck, Sanofi, Bayer and other companies have had product licenses revoked.

4. Shanghai Reduces Prices for Some Medical Service Items

On October 13, the Shanghai Municipal Medical Security Bureau and the Shanghai Municipal Health Commission issued the "Notice on Reducing the Prices of Some Medical Service Items in the City." It specifies adjustments to the costs of two testing items: continuous dynamic blood glucose monitoring, and Mycobacterium tuberculosis rpoB gene and mutation detection.The adjusted price standards for the two are 200 yuan/day and 300 yuan/time, respectively.

1. CEO and Vice Chairman of TOT Biopharm Both Resign

On October 13, Dongyao Pharma announced that Mr. Shan Fu will be transferred from a non-executive director to an executive director of the company effective from October 11, 2025. He will be responsible for leading and overseeing the management and development of the group and will continue to serve as the chairman of the company.Liu Jun resigned as Executive Director, Chief Executive Officer, and Chief Scientific Officer of the company;Ms. Huang Chunying has resigned as a non-executive director and vice chairwoman of the company. These two individuals have stepped down from all directorial and executive positions in all subsidiary companies of the company.

2. Pien Tze Huang Establishes Two Companies

On October 13 and 14, Pien Tze Huang, a leading traditional Chinese medicine company, successively participated in the establishment of two new companies: Guangsheng Hehuang (Zhangzhou) Pharmaceutical Co., Ltd. and CICC (Zhangzhou) Medical Industry Investment Partnership.

Guangsheng Hehuang has a registered capital of 50 million yuan, jointly established by Fujian Pien Tze Huang Health Technology Co., Ltd. under Pien Tze Huang and Fujian Guangsheng Hall, with the former holding 49% and the latter holding 51%.

CICC Healthcare was jointly established by Zhangzhou Pien Tze Huang Investment Management Co., Ltd. and Zhangzhou Pien Tze Huang Asset Management Co., Ltd., both subsidiaries of Pien Tze Huang, together with CICC Capital Operation Co., Ltd. and several state-owned asset platforms in Zhangzhou, among 8 enterprises.Registered capital of 1 billion yuan.Pien Tze Huang Investment Management and Pien Tze Huang Asset Operation each contributed 200 million yuan.

3. Mindray Medical Officially Announces Plan to Go Public in Hong Kong

On October 14, Mindray Medical announced,The company plans to issue H-share stocks and list on the Main Board of the Hong Kong Stock Exchange.At the same time, in the investor relations activity record table released on the same day, the purpose and necessity of the Hong Kong listing were also addressed. It was stated that this overseas issuance and listing is an important step in the company's firm implementation of its "internationalization" strategy.

4, 1 Billion Euros! Sanofi Beijing Insulin Project Launched

On October 17, Sanofi announced the official launch of its insulin active pharmaceutical ingredient (API) project located in Beijing Economic and Technological Development Zone. The production base was first disclosed in December 2024.Total investment amounting to 1 billion euros.

This is not only the first insulin active pharmaceutical ingredient production base in China established by a multinational company, but also sets the record for the largest investment in Beijing's pharmaceuticals industry since the '14th Five-Year Plan.' The new base will consist of multiple production and supporting buildings, with a total construction area of nearly 60,000 square meters, and is expected to be fully completed and put into operation by 2032.

5. Bailing Tianheng Receives $250 Million Milestone Payment

On October 12, Biotech announced that the global Phase II/III pivotal registration clinical trial for the EGFR×HER3 bispecific ADC drug iza-bren (BL-B01D1), developed in collaboration with BMS, has reached a milestone event.Officially triggered the first $250 million near-term contingent payment condition under the BMS collaboration agreement.

1. GSK's Recombinant Shingles Vaccine Approved for New Indication in China

On October 14, GSK announced that the NMPA had approved the recombinant shingles vaccine Shingrix for use in China.18 years old and abovePrevention of herpes zoster in adults with an increased risk of developing the disease due to immunodeficiency or immunosuppression caused by known diseases or treatments (e.g., autologous hematopoietic stem cell transplantation).

2. Fudan Zhangjiang's Generic Obeticholic Acid Tablets Rejected for Market Entry

On October 13, Fudan Zhangjiang announced that the registration application for obeticholic acid tablets, used to treat primary biliary cholangitis, was not approved due to non-compliance with relevant drug registration requirements.The project has accumulated R&D investment of approximately 125 million yuan.

The main reason for the rejection by the National Medical Products Administration (NMPA) is that obeticholic acid tablets are a generic version of a drug that was granted conditional approval overseas but has not been marketed in China, and its reference product (the original research drug) has also not received full approval abroad.

3. Oral Semaglutide New Indication Approved for Marketing

On October 17, Novo Nordisk announced that the FDA had officially approved a new indication for Novo Nordisk's oral semaglutide tablets, for reducing the risk of major adverse cardiovascular events (MACE) in high-risk patients with type 2 diabetes. Thus,Semaglutide tablets become the first orally-administered GLP-1 drug approved for this indication.

This approval is based on the results of the Phase 3b cardiovascular outcome trial named SOUL. This large-scale study enrolled 9,650 patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease, marking the largest cardiovascular safety study for oral GLP-1 class drugs to date.

Author | Taozhi Fang

Editor | Jiang Yun, Jia Ting

Operation | Morning Glow

Illustration | Visual China

Statement: Original content by Jian Shi Bureau, please do not reprint without permission.

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