Author: Zhang Kexin Source: China Food and Drug Network

China Food and Drug Network News The General Office of the State Council issued the "Opinions of the General Office of the State Council on Promoting High-quality Development of Service Trade with High-level Opening", proposing to vigorously develop biopharmaceutical R&D outsourcing, etc.; the National Development and Reform Commission and the Ministry of Commerce issued the "Special Management Measures for Foreign Investment Access (Negative List) (2024 Edition)", deleting "Prohibition of investment in the application of steaming, frying, roasting, calcining and other processing technologies of Chinese herbal medicines and the production of confidential prescription products of Chinese patent medicines" and other items... From September 2 to September 8, these dynamics in the pharmaceutical industry are worth paying attention to.

Industry and Policy Dynamics

1. The General Office of the State Council issued the "Opinions of the General Office of the State Council on Promoting High-quality Development of Service Trade with High-level Opening" (hereinafter referred to as the "Opinions"), proposing 20 key tasks in six aspects. In terms of promoting innovation and development in key areas, the Opinions proposes to vigorously develop new service outsourcing models including biopharmaceutical R&D outsourcing; promote the healthy development of traditional Chinese medicine service trade and actively develop "Internet + traditional Chinese medicine service trade"; promote the integrated development of service trade and high-end manufacturing, and introduce special policy measures in the fields of biopharmaceuticals and other fields; focus on the needs of residents' consumption upgrades and promote the import of high-quality life services such as medical health.

2. The National Development and Reform Commission and the Ministry of Commerce issued the "Special Management Measures for Foreign Investment Access (Negative List) (2024 Edition)", which will take effect on November 1, 2024. The 2024 version of the national negative list for foreign investment access has reduced the number of restrictive measures from 31 to 29, deleted two items such as "prohibiting investment in the application of steaming, frying, roasting, calcining and other processing technologies of Chinese herbal medicines and the production of confidential prescription products of Chinese patent medicines", and completely abolished the restrictive measures on foreign investment access in the manufacturing industry.

3. The Ministry of Commerce, the National Health Commission and the State Food and Drug Administration issued a notice to carry out pilot work on expanding opening up in the medical field. In the field of biotechnology, from the date of issuance of the notice, foreign-invested enterprises are allowed to engage in the development and application of human stem cells, gene diagnosis and treatment technologies in the China (Beijing) Pilot Free Trade Zone, the China (Shanghai) Pilot Free Trade Zone, the China (Guangdong) Pilot Free Trade Zone and the Hainan Free Trade Port for product registration, listing and production. In the field of wholly-owned hospitals, it is planned to allow the establishment of wholly foreign-owned hospitals (except for traditional Chinese medicine hospitals, excluding mergers and acquisitions of public hospitals) in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and the entire island of Hainan.

4. The Ministry of Finance, the National Health Commission, the General Administration of Customs, the State Administration of Taxation and the State Drug Administration jointly issued the "Notice on the "Zero Tariff" Policy for Drugs and Medical Devices in the Hainan Free Trade Port". The notice clearly states that before the whole island is closed, medical institutions, medical colleges and universities, and medical research institutes registered and registered in the Hainan Boao Lecheng International Medical Tourism Pilot Zone with independent legal person status and certified, import drugs and medical devices specified in the notice [including: imported drugs and medical devices that have been approved for registration in my country; drugs (excluding vaccines) and medical devices that have not yet been approved for registration in my country according to relevant regulations of the State Council, but are approved by the Hainan Provincial People's Government to be imported and used in the Lecheng Pilot Zone], and used in accordance with the provisions of this policy, can be exempted from import tariffs and import value-added tax.

5. The State Administration for Market Regulation issued the "Key Measures for Market Supervision Departments to Optimize the Business Environment (2024 Edition)" (hereinafter referred to as the "Key Measures"). The "Key Measures" include 10 parts, including accelerating the improvement of institutional rules in the field of market supervision, and promoting strict, standardized, fair and civilized law enforcement, with a total of 40 specific measures. For the first time, the "Key Measures" regards building a solid safety bottom line as an important part of optimizing the business environment, and clearly proposes to strictly prevent and strictly control drug safety risks.

6. The National Health Commission, the State Administration for Market Regulation and 14 other departments issued the "Guiding Opinions on Promoting Healthy Village Construction" (hereinafter referred to as the "Guiding Opinions"). The "Guiding Opinions" proposed to strive to achieve a series of construction goals, such as setting up TCM clinics and equipping TCM doctors in all township health centers, and more than 80% of village clinics can provide TCM services.

7. The State Food and Drug Administration issued an announcement, deciding to uniformly revise the [Warnings], [Adverse Reactions], [Contraindications] and [Precautions] in the instructions for pediatric food preparations (including pediatric food oral liquid and pediatric food pills) and anti-cough and asthma preparations [including anti-cough and asthma syrup (containing alcohol), anti-cough and asthma syrup (non-alcohol), anti-cough and asthma granules (tablets, dispersible tablets, capsules)].

8. The Center for Drug Evaluation of the State Food and Drug Administration (CDE) publicly solicited opinions on the "Technical Guidelines for Vaccine Clinical Trials (Revised Draft) (Draft for Comments)". The deadline for soliciting opinions is 1 month from the date of publication.

9. CDE released the "Catalogue of Reference Preparations for Chemical Generic Drugs (86th Batch)" (Draft for Comments) and publicly solicited opinions, involving varieties such as clindamycin phosphate benzoyl peroxide gel.

10. The CDE website announced 10 generic drug consistency evaluation tasks, involving varieties such as cephalexin granules (as of September 8).

CDE website announced 10 generic drugs

Product R&D and listing information

1. The State Food and Drug Administration issued the delivery information of the 4th phase of drug approval documents, including a total of 194 acceptance numbers, involving companies such as Shanxi Taiyuan Pharmaceutical Co., Ltd. (as of September 8).

2. CDE accepted 56 new drug marketing applications, including LP-003 injection, etc. (as of September 8).

56 new drug marketing applications

3. Innovent Biologics announced that its PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 has been granted fast track status by the U.S. Food and Drug Administration (FDA), with the proposed indication being locally advanced or metastatic melanoma (excluding choroidal melanoma) that has progressed after at least one line of systemic treatment with PD-1/L1 checkpoint inhibitors.

4. Huiyu Pharmaceuticals announced that its product, sodium valproate injection concentrated solution, has been approved and issued a marketing authorization by the Irish Medicines Regulatory Authority.

5. Innovent announced that its innovative stroke drug, edaravone and dexamethasone sublingual tablets, developed in collaboration with Ningdan New Drug, has been granted “breakthrough therapy designation” by the U.S. FDA for the treatment of acute ischemic stroke.

6. Hanyu Pharmaceuticals announced that its somatostatin API received the CEP certificate (API European Pharmacopoeia Suitability Certificate) issued by the European Directorate for the Quality of Medicines and HealthCare.

7. Tonghe Pharmaceuticals announced that the company recently received the drug registration certificate for vildagliptin issued by the Korean Ministry of Food and Drug Safety.

Pharmaceutical Company Observation

1. Epigenetics and Vignette Bio announced that the two parties have reached a licensing agreement for Epigenetics' T cell engagement (TCE) molecule EMB-06 targeting BCMA. Epigenetics will grant Vignette the exclusive right to develop and commercialize EMB-06 outside of Greater China (including mainland China, Hong Kong, Macau and Taiwan).

2. Enos was listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange with an issue price of 19.06 yuan per share.

3. Lianhuan Pharmaceuticals announced that the company recently received an on-site inspection report issued by the US FDA, and the company's production site has passed the cGMP (current pharmaceutical production quality management specification) on-site inspection accepted from July 15 to 19, 2024.

4. Innovent, an innovative anti-tumor drug company under Innovent Pharmaceutical Group, announced that it has recently entered into a cooperation agreement with Shenzhen Tajiri Biopharmaceutical Co., Ltd. on the clinical-stage anti-tumor candidate drug ALK/ROS1 dual receptor tyrosine kinase inhibitor TGRX-326. According to the terms of the agreement, Innovent will obtain exclusive commercialization rights of TGRX-326 in mainland China (including but not limited to the promotion of TGRX-326, the formulation and adjustment of relevant strategies and the right to obtain related interests, etc.).

5. Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of Tiantan Biological Holdings, intends to acquire 100% of the equity of Wuhan Zhongyuan Ruide Biological Products Co., Ltd., a wholly-owned subsidiary of CSL Asia Pacific, for a total amount of US$185 million.

Centralized procurement of drugs

1. Jiangsu Provincial Medical Insurance Bureau issued the "Announcement on the Jiangsu Alliance's Continued Procurement of the 4th and 5th Batch of National Organized Drug Centralized Procurement Agreement Expired Varieties (I)". In accordance with the relevant requirements of the National Medical Insurance Administration, Jiangsu, Anhui, Hubei, Guangxi, Chongqing, Sichuan, Guizhou, Yunnan, Shaanxi, Gansu, Qinghai and other provinces have formed an inter-provincial alliance to carry out follow-up procurement of 47 drugs whose 4th and 5th batches of national centralized procurement agreements have expired.

2. Shanghai Sunshine Pharmaceutical Procurement Network issued the "Notice on the Announcement of the List of Drugs Listed for Public Negotiation and Procurement Supervision in July 2024", announcing the varieties of drugs listed for public negotiation in July 2024 that exceeded the "yellow line", failed to pass the fairness assessment, and were key monitored drugs with a certain purchase amount, reminding medical institutions to negotiate reasonably. (Compiled by our reporter Zhang Kexin)

(Editor: Zhou Yutong)