Four New Drugs Receive Market Approval in China: Antiretroviral, Antipsychotic, Dermatological, and Anti-ulcer Therapies Launched

According to the latest corporate announcements, Qilu Pharmaceutical's Entrectinib Tablets, Huahai Pharmaceutical's Quetiapine Fumarate Tablets, Fuyuan Pharmaceutical's Fluticasone Propionate Cream, Huiyu Pharmaceutical's Famotidine Injection, and Shanghai Pharmaceutical's Valganciclovir Hydrochloride Tablets have been successively approved for marketing in recent days. The following are the detailed profiles of the four drugs:

1. Qilu Pharmaceutical's "Entrectinib Tablets" Approved for Exclusive Market Launch

On July 16, according to the official website of the National Medical Products Administration, Qilu Pharmaceutical's Entrectinib Tablets (Tweino®) for the treatment of HIV-1 (Human Immunodeficiency Virus Type 1) infection received marketing approval, making it the exclusive product approved for marketing in China.

AIDS is a contagious disease caused by the infection of the human immunodeficiency virus (HIV). AIDS cannot be completely cured at present, and patients need to take multiple medications for a long time. Entecavir and Rilpivirine Tablets are suitable for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥35kg.

Entecavir and Rilpivirine Hydrochloride and Tenofovir Alafenamide Fumarate Tablets are composed of entecavir, rilpivirine hydrochloride, and tenofovir alafenamide fumarate. Entecavir is a nucleoside reverse transcriptase inhibitor that can block the synthesis of viral DNA chains. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that inhibits viral replication by non-competitively inhibiting HIV-1 reverse transcriptase and exhibits broad-spectrum antiviral activity against various HIV-1 subtypes.

Tenofovir alafenamide is converted into its active form, tenofovir, in the body, and then transformed into tenofovir diphosphate through a phosphorylation process, inducing termination of viral DNA chain replication. The combination regimen of these three drugs has proven efficacy and is a guideline-recommended antiviral treatment for both adult and adolescent patients who are new to therapy. A single-tablet regimen is more convenient to take, requiring only one tablet per day, which helps reduce the medication burden on patients and improve adherence.

Currently, the original Entrectinib capsules have not yet been launched in China, and the approval and market launch of Tewino® provide patients with more diversified and convenient treatment options.

2. Huahai Pharmaceutical's "Quetiapine Fumarate Tablets" Approved for Marketing

On July 16, Huahai Pharmaceutical announced that it had recently received the "Drug Registration Certificate" for Quetiapine Fumarate Tablets issued by the National Medical Products Administration.

Basic Information of Quetiapine Fumarate Tablets:

Drug Name: Quetiapine Fumarate Tablets
Dosage Form: Tablets
Specification: 25mg (as C21H25N3O2S)
Application Item: Drug Registration (Produced in China)
Registration Category: Chemical Drug Class 4
Applicant: Zhejiang Huahai Pharmaceutical Co., Ltd.
Drug Approval Number: National Drug Approval No. H20244401

Approval Conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration, and is approved for registration, issuing a drug registration certificate.

Quetiapine Fumarate Tablets are used to treat schizophrenia and manic episodes of bipolar disorder. Quetiapine Fumarate Tablets were originally developed by AstraZeneca and launched in the United States in September 1997, with approval for marketing in China in June 2000. Currently, the main manufacturers in China that have obtained the drug registration certificate include Hunan Dongting Pharmaceutical Co., Ltd., Guangdong East Sun Pharmaceutical Co., Ltd., etc. According to data forecasts, the domestic market sales revenue of Quetiapine Fumarate Tablets in 2023 is approximately RMB 1.13 billion.

As of now, the company has invested approximately RMB 24.35 million in the research and development project for Quetiapine Fumarate Tablets.

3. Fuyuan Pharmaceutical "Fluticasone Propionate Cream" Approved for Marketing

On July 17, Fuyuan Pharmaceutical released a corporate announcement stating that its wholly-owned subsidiary, Fuyuan Pharmaceuticals, had received the "Drug Registration Certificate" (Certificate No.: 2024S01684) for Fluticasone Propionate Cream [Specification: 0.05% (15g∶7.5mg), hereinafter referred to as "the drug"] issued by the National Medical Products Administration.

Basic Information of Fluticasone Propionate Cream:

Name: Fluticasone Propionate Cream
Dosage Form: Cream
Registration Category: Chemical Drug Class 4
Specification: 0.05% (15g:7.5mg)
Drug Approval Number: National Drug Approval No. H20244439
Drug Registration Standard Number: YBH15272024
Application Item: Drug Registration (Produced in China)

Approval Conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration, and is approved for registration, issuing a drug registration certificate. The quality standards, instructions, labels, and production processes shall be implemented as attached. Pharmaceutical manufacturing enterprises must comply with the requirements of Good Manufacturing Practice (GMP) for pharmaceuticals before they can produce and sell.

Fluticasone Propionate Cream is a topical corticosteroid suitable for adults, and children aged one year and above, used to relieve inflammatory and pruritic symptoms of dermatoses responsive to corticosteroids.

Fuyuan Pharmaceutical received the acceptance notice for application on February 9, 2023, and was recently approved by the National Medical Products Administration. According to relevant national policies, obtaining the "Drug Registration Certificate" this time is considered as passing the consistency evaluation. Fuyuan Pharmaceutical is the first company (considered) to pass the consistency evaluation for this drug. As of the date of this announcement, Fuyuan Pharmaceutical's total R&D investment in this drug has amounted to RMB 9.0688 million (unaudited).

According to the information on the website of the National Medical Products Administration, apart from the original research import, only Fuyuan Pharmaceutical in China has obtained the drug registration certificate for Fluticasone Propionate Cream (approved as a generic drug under Category 4), making it the first company to be considered as having passed the consistency evaluation.

According to the data, in 2023, the three major terminals and six major markets of Fluocinonide Propionate in China

Sales of Songru膏 amounted to approximately 508 million yuan, including 411 million yuan from urban public hospitals and county-level public hospitals, 30 million yuan from urban community centers and township health centers, 47 million yuan from physical pharmacies in cities, and 20 million yuan from online pharmacies.

4. Huiyu Pharmaceutical "Famotidine Injection" Exclusively Approved for Marketing

On July 17, Huiyu Pharmaceutical released a corporate announcement stating that its wholly-owned subsidiary, Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd., had recently received the "Drug Registration Certificate" issued by the National Medical Products Administration.

Basic Information of Famotidine Injection:

Drug Name: Famotidine Injection
Dosage Form: Injection
Specification: 2ml: 20mg
Registration Category: Chemical Drug Class 3
Drug Expiration Date: 18 months
Application No.: CYHS2300642
Certificate No.: 2024S01629
Drug Approval Number: National Drug Approval No. H20244386
Marketing Authorization Holder: Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd.
Manufacturer: Taichi Group Sichuan Taichi Pharmaceutical Co., Ltd.

Approval Conclusion: According to the "Measures for the Administration of Pharmaceuticals of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration, and its registration is approved. A drug registration certificate is issued. The quality standards, instructions, labels, and production processes are to be implemented as per the attached documents. Pharmaceutical manufacturing enterprises must comply with the requirements of Good Manufacturing Practice (GMP) for pharmaceuticals before they can produce and sell.

Famotidine is a competitive inhibitor of histamine H2 receptors. It inhibits gastric acid secretion (including gastric acid concentration and gastric juice volume) by blocking H2 receptors in the parietal cells of the gastric mucosa. Meanwhile, the secretion volume of pepsin is proportional to the secretion volume of gastric juice. This product is suitable for upper gastrointestinal bleeding caused by peptic ulcers, and erosive hemorrhage of the stomach and duodenal mucosa due to various causes except tumors and esophageal and gastric varices.

The original research company, LTL Pharma Co., Ltd.'s Famotidine Injection has not yet been marketed in China. Currently, six companies in China hold the approval for Famotidine Injection, including Yabang Pharmaceutical and Chongqing Yaogu Pharmaceutical, among others. According to data, the sales revenue of Famotidine Injection in Chinese urban public hospital terminals was approximately 360 million yuan in 2023.

Famotidine Injection is registered as Category 3 of chemical drugs, and was reviewed and approved according to the technical requirements for consistency in quality and efficacy with the reference product. After approval, it is considered to have passed the generic drug quality and efficacy consistency evaluation.

Editor: Bai Ji

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