Author: Zhang Kexin Source: China Food and Drug Network

The General Office of the CPC Central Committee and the General Office of the State Council issued the "Opinions on Improving the Market Access System", proposing to optimize the market access environment for new formats and new fields, select fields such as biomedicine, promote key enterprises, research institutions and other innovative units and relevant localities to establish a global frontier scientific research collaborative model in related fields, and actively participate in the formulation of international market access rules and standards; the Supreme People's Court issued the "Interpretation on Several Issues Concerning the Application of Law in Trial of Food and Drug Punitive Compensation Dispute Cases"; the Drug Evaluation Center of the State Food and Drug Administration publicly solicited opinions on the "Guidelines for Clinical Virology Research and Data Submission of Anti-HIV-1 Infection Drugs (Draft for Comments)"... From August 19 to August 25, these dynamics in the pharmaceutical industry are worth paying attention to.

Industry and Policy Dynamics

1. The General Office of the CPC Central Committee and the General Office of the State Council issued the "Opinions on Improving the Market Access System", proposing to optimize the market access environment for new formats and new fields, select fields such as biomedicine, promote key enterprises, research institutions and other innovative units and relevant localities to establish a global frontier scientific research collaborative model in related fields, actively participate in the formulation of international market access rules and standards, and promote the convenient and efficient application of innovative achievements in key fields.

2. The Supreme People's Court issued the "Interpretation on Several Issues Concerning the Application of Law in Trial of Food and Drug Punitive Compensation Dispute Cases" (hereinafter referred to as the "Interpretation"). The "Interpretation" has a total of 19 articles, which stipulates the protection of ordinary consumers' rights, refunds and returns of food and drugs, the responsibility of purchasing agents, the competition of punitive compensation liability, the responsibility of producing and selling fake and inferior drugs, the determination of the base of punitive compensation, and the punishment of illegal claims. The "Interpretation" will take effect on August 22.

3. The State Food and Drug Administration issued an announcement that Shenqi Eleven Granules will be converted from prescription drugs to over-the-counter drugs. The list of varieties and the template of over-the-counter drug instructions were released together.

4. The State Food and Drug Administration issued an announcement on the resumption of import, sale and use of UCB Pharma S.A. Levetiracetam Concentrated Solution for Injection, and decided to resume the import, sale and use of Levetiracetam Concentrated Solution for Injection produced by UCB Pharma S.A. from June 4, 2024.

5. CDE publicly solicited opinions on the "Guidelines for Clinical Virology Research and Data Submission of Anti-HIV-1 Infection Drugs (Draft for Comments)". The guidelines are mainly applicable to the clinical development of HIV-1 antiviral drugs, and provide technical suggestions on clinical virology research and data submission. The deadline for soliciting opinions is 1 month from the date of publication.

6. The CDE website announced 6 generic drug consistency evaluation tasks, involving varieties such as tramadol hydrochloride injection (as of August 25).

CDE website announced 6 generic drugs

Product development and marketing information

1. The National Medical Products Administration issued 4 phases of drug approval certificate delivery information, including 125 acceptance numbers, involving companies such as Qilu Pharmaceutical Co., Ltd. (as of August 25).

The National Medical Products Administration issued 4 phases of drug approval certificate documents

2. CDE undertook the acceptance of 36 new drug marketing applications, including KYS202003A injection, etc. (as of August 25).

CDE undertook the acceptance of 36 new drug marketing applications

3. The application for protection of the traditional Chinese medicine variety of Shuangdan Mingmu Capsule (initial protection) submitted by Beijing Qihuang Pharmaceutical Co., Ltd. and the application for protection of the traditional Chinese medicine variety of Xueshuantong (freeze-dried) for injection (initial protection) submitted by Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd. have been accepted by the National Medical Products Administration.

4. Renfu Pharmaceutical announced that its wholly-owned subsidiary Epic Pharma, LLC (hereinafter referred to as Epic Pharma)'s product ursodeoxycholic acid tablets has obtained the approval number of the US Food and Drug Administration (FDA), and is qualified for sale in the US market.

5. Yipinhong announced that its shareholding company Arthrosi's innovative drug AR882 has obtained the Fast Track Designation (FTD) granted by the US FDA for the treatment of visible tophi in clinical gout patients.

Pharmaceutical Enterprise Observation

1. Hengrui Medicine released its semi-annual report. The semi-annual report shows that Hengrui Medicine's operating income in the first half of 2024 was 13.601 billion yuan, an increase of 21.78% over the same period last year; the revenue from innovative drugs reached 6.612 billion yuan (including tax, excluding external licensing income), achieving a year-on-year growth of 33%, becoming an important engine for performance growth.

2. CSPC Pharmaceutical Group released its financial report for the first half of 2024. CSPC Pharmaceutical Group's revenue in the first half of 2024 was 16.284 billion yuan, an increase of 1.3% over the same period last year; R&D expenses were 2.542 billion yuan, an increase of 10.3% over the same period last year; currently more than 60 key drugs under development have entered the clinical or application stage, of which 7 have submitted listing applications, and 19 products (22 indications) are in the registration clinical stage.

3. Beida Pharmaceuticals issued an announcement on the company and its holding subsidiaries passing the on-site inspection of the US FDA. It is understood that Beida Pharmaceuticals and its holding subsidiary Xcovery Holdings, Inc (hereinafter referred to as Xcovery) accepted the US Food and Drug Administration's clinical BIMO (Bioresearch Monitoring)-related PAI (Pre-Approval Inspection) on-site inspection and API CMC (Chemical Manufacture and Control) PAI on-site inspection in May and June 2024, respectively. Recently, Beida Pharmaceuticals and Xcovery found on the US FDA official website that Beida Pharmaceuticals and Xcovery passed the above-mentioned on-site inspections with zero defects.

4. Kelun Pharmaceuticals issued an announcement stating that its holding subsidiary Kelun Botai recently received a written notice from Merck that Merck will exercise an exclusive option for the SKB571 project and pay Kelun Botai US$37.5 million; after achieving specific development and sales milestones, it will pay Kelun Botai further milestone payments, and pay tiered royalties calculated based on net sales after SKB571 is commercialized. Kelun Biotech will retain the rights to develop, use, manufacture and commercialize SKB571 in mainland China, Hong Kong and Macau. It is understood that SKB571 is an innovative bispecific ADC that mainly targets various solid tumors such as lung cancer and gastrointestinal tumors. The product will submit an IND application in the near future.

5. Tongyuankang Pharmaceutical was officially listed on the Hong Kong Stock Exchange on August 20. It is understood that Tongyuankang Pharmaceutical is a clinical-stage biopharmaceutical company dedicated to discovering, acquiring, developing and commercializing differentiated targeted treatment solutions to meet the urgent medical needs in cancer treatment. Since its establishment, the company has established a pipeline of 11 drug candidates, including the core product TY-9591, 6 clinical-stage products and 4 preclinical or early clinical development products.

6. Duorui Pharmaceuticals announced that its wholly-owned subsidiary Hubei Duorui signed a technology transfer contract with Pudekangli. Hubei Duorui intends to acquire 60% of the product rights and interests of amisulpride injection from Pudekangli for RMB 22.56 million, and Pudekangli, as the research and development entity of the product, retains 40% of the rights and interests. After the completion of this transaction, Hubei Duorui will apply for production as the drug marketing license holder, and Hubei Duorui and Pudekangli will distribute the sales revenue and other related rights and interests of the product in a ratio of 6:4.

Centralized procurement of drugs

1. The National Medical Insurance Administration announced the disposal results of the previous national drug centralized procurement case of bromhexine hydrochloride injection. Six bidding companies for bromhexine hydrochloride injection, including Chengdu Xinjie High-tech Development Co., Ltd., Renhe Yikang Group Co., Ltd., and Guangzhou Yipinhong Pharmaceutical Co., Ltd., were suspended from participating in the national procurement to varying degrees and were included in the list of violations.

2. The Jiangxi Provincial Medical Insurance Bureau website released the "Implementation Plan for the "Three-in" Action of Centralized Procurement of Drugs in Jiangxi Province", and decided to carry out the action of centralized procurement of drugs into "retail pharmacies, private medical institutions, and village clinics" across the province.

3. The Guizhou Provincial Public Resources Trading Network issued the "Notice of the Provincial Medical Insurance Bureau on Adjusting the Transaction Prices of 124 Drugs in the 13th Batch in 2024", and 81 companies including Xi'an Libang Pharmaceutical Co., Ltd. submitted price reduction applications for 124 drugs. The adjusted prices will be officially implemented on August 20, 2024.

4. The Qinghai Provincial Drug Procurement Center issued a notice on adjusting the prices of some drugs, and adjusted the prices of drugs such as Sitagliptin Phosphate Tablets. (Compiled by our reporter Zhang Kexin)

(Editor in charge of China Food and Drug Network: Zhou Yutong)