Points of medicine every week (8.24-8.30)

China Food and Drug Network News The State Drug Administration released the 57th batch of generic drug reference preparations; Omeprazole entero -soluble tablets were converted from prescription drugs to over -the -counter drugs ... August 24th to August 30th, these in the pharmaceutical industry Dynamic is worthy of attention.

Industry policy dynamics

1. The State Drug Administration issued the Catalog of the Victory Drug Reference Preparation (57th Batch), which involves drugs such as methadosilicate Dalafiniic capsules.

2. The State Drug Administration issued an announcement that Omeprazole entero -soluble tablets were converted from prescription drugs to over -the -counter drugs. The list of varieties and its over -the -counter drug manuals is released together.

3. The National Health and Health Commission, the State Administration of Traditional Chinese Medicine, and the State CDC and other three departments jointly issued the "Measures for Network Security of Medical and Health Institutions". The "Measures" clarify the basic principles of network and data security management, management, implementation standards, supervision and punishment requirements of various medical and health institutions, and point out the general direction of network security management for medical and health institutions.

4. The State Drug Administration's Pharmaceutical Review Center (CDE) Publicized chemical generic drug reference preparations (62 batch), involving drugs and other medicines such as Boson Tan Disposter. The publicity period is from August 30th to September 13th, 2022.

5. CDE publicly solicited opinions on the "Guidance Principles of Chemical Drug Manuals and Label Pharmacy Related Information (Draft for Solicitation Opinions)", which aims to strengthen the regulatory management of drug manuals and labels, guide clinical use of drugs, promote the orderly development of enterprises and draft and draft. Improve the work of instructions and labeling Chinese medicine information. The deadline for solicitation is September 29, 2022.

6. CDE publicly solicited opinions on the "Principles of the Technical Guidance of Soluble Drops of Dripping Dripping Dripping Pharmaceutical Pharmacy (Draft for Soliciting Opinions)". The deadline for solicitation is September 28, 2022.

Product research and development/listing information

1. The State Drug Administration of Belgium UCB PHARMA S.A. Organized the overseas non -on -site inspection of drugs, and the variety of inspection was Zuo Yican injection for a thick solution (import registration certificate number: H20170341, specification 5 ml: 500 mg, the product name Kaipu Pupu orchid). This inspection found that the validity period of the batch of the batch of the product is inconsistent with the validity period of the registration approval. The inspection conclusion is that the production of this variety does not meet the requirements of my country's "Drug Production Quality Management (Revised in 2010)". In order to ensure the safety of public medication, according to the relevant provisions of the Drug Administration of the People's Republic of China, the State Drug Administration decided that from August 24, 2022, the product was suspended from importing, selling and use in China, and investigating related issues in accordance with the law according to law deal with. Each imported port drug supervision and management department suspended the distribution of import customs clearance vouchers of the product.

2. The State Drug Administration issued 2 phase of pharmaceutical approval documents to receive information, including 135 acceptance numbers, involving Pfizer Pharmaceutical Technology Co., Ltd. and other companies. (As of August 30)

3. CDE website publicize 12 imitative drug consistency evaluation tasks, involving drugs and other drugs such as stagamin hydrochloride injection. (As of August 30)

4.CDE hosts 34 new drug listing applications, including ZX2021 injection and other drugs. (As of August 30)

Observation of pharmaceutical enterprises

1. Gan Li Yaoye issued an announcement saying that it received the registration approval of the martial winter insulin injection of the door winter approved by the Ministry of Health of Kazakhstan.

2. Junshi Bio announced that Suzhou Junjing Biological, which was jointly invested with Weiying Bio, received a notice from the US Food and Drug Administration (FDA), and the clinical trial application of XPO1 inhibitor WJ01024 (project code "JS110") Obtained FDA approval.

3. The Tenno Macro Bio announced that its independently developed TNM002 injection liquid was qualified to be awarded the FDA by the US FDA.

4. Yimingangko announced that its independently developed humanized IGG1 CD70 antibody drug (item number: IMM40H) obtained the US FDA clinical trial permit.

5. Quanxin Bio announced that its independently developed monoclonal anti -anti -anti -anti -qx008N obtained the clinical trial permit of the US FDA, and the indication was severe asthma.

6. Shanghai Pharmaceutical and Yunnan Baiyao signed the "Daily Related Transaction/Continuous Related Transaction Framework Agreement". According to the agreement, from April 1, 2022 to December 31, 2022, Shanghai Pharmaceutical's upper limit of the amount of products from Yunnan Baiyao's procurement was RMB 243 million; the upper limit of the sales product amount to Yunnan Baiyao was 508 million yuan.

7. Banke Bio announced the completion of more than 10 million yuan of angel round financing. This round of financing was led by Donghu Investment. This round of financing will be used for clinical pre -clinical research of Banke biological antiviral nano -antibody drugs, as well as the advancement of other R & D pipelines and team building.

8. Li's Da Pharmaceutical Factory announced that Surfaxin (KL4 surfactant), Surfaxin LS (frozen -dried KL4 surfactant), Aerosurf, and any other medical components containing synthetic KL4 surfactants with synthetic KL4 surfactants with synthetic KL4 surfactants with Surfaxin LS containing exclusive global development , Rights production and commercialization. These three products are mainly used to improve the management of premature baby respiratory distress syndrome. Windtree will receive up to $ 78.9 million for development, supervision and commercial milestones, and franchise fees.

Pharmaceutical concentrated procurement

1. The Shenzhen Medical Insurance Bureau issued the "Notice on the Relevant Matters of the Connect of the Connection of the New Drug Procurement Management Policies", and the transition period of Shenzhen New and Old Drug Procurement Management Policy was expired on August 31, 2022. Shenzhen public medical institution drug procurement service contracting agencies have been generated by government procurement, and the winning bid suppliers are Shenzhen Quan Pharmaceutical Pharmaceutical Co., Ltd. From September 1, 2022, the undertaking agency shall be responsible for the operation of the information platform of Shenzhen Drug Procurement and Trading in accordance with the "Administrative Measures" and the contract contracting contract of the drug procurement and trading service. Concentrated settlement and cross -regional joint procurement work, providing relevant parties with high -quality and efficient pharmaceutical procurement trading services. 2. The Guangdong Pharmaceutical Exchange Center announced the results of Chinese medicine collection, Qing Kai Ling and other pharmaceutical collection and Qing Kai Ling and other common diseases and chronic diseases. The results of the selection clearly clarified the selection and alternative results, and also clarified whether to obtain incremental use. According to the procurement documents, the alternative product obtains the corresponding distribution qualifications according to the price reduction range. In addition, the selection results of individual varieties need to be further verified and studied, and the specific results will be notified separately after verification.

3. Shaanxi Pharmaceutical Association issued the "Consensus on Scientific Management Experts of Medical Institutions in the Five West Provincial Medical Institutions in Northwest", which aims to explore the management model of scientific, standardized, and informatization of drugs, improve the fine operation level of medical institutions To better achieve the patient -centered medication target centered on the normalization of the collection, for various medical institutions for reference in related work. [Comprehensive Finance of China Food and Drug Network/Liu Sihui]

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