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China’s first AAV gene therapy breaks through

Recently, China’s gene therapy field has ushered in a historic breakthrough – Xinxin Pharmaceutical’s AAV gene therapy Xinjiuning® (BBM-H901 injection, generic name: Bopidarcoside injection) was approved for marketing, becoming the first approved gene therapy drug for hemophilia B in China. The code to break the game The breakthrough of BBM-H901 is not only reflected in the innovation of the technical path, but also in the overall leap in its clinical value. Through precise gene delivery and long-term expression mechanism, the drug breaks the limitations of traditional therapies and opens a new era in the treatment of hemophilia. From the perspective of annualized bleeding rate, the annualized bleeding rate of patients under traditional treatment is usually high. The ABR determined for the domestic preventive treatment population is about 5.0, while the average ABR of subjects after treatment with BBM-H901 injection is only 0.6 (95% Cl: 0.18-1.99). This means that the bleeding ...
- Source: drugdu
- 99
- April 17, 2025
CPHI & PMEC China

Organiser：Informa Markets Time：September 1st – 3rd, 2025 address：Shenzhen Convention and Exhibition Center, Fuhua 3rd Road, Futian District, Shenzhen Exhibition hall：Shenzhen Futian Convention and Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs) and Intermediates, Biopharmaceuticals, Pharmaceuticals, Pharmaceutical Excipients, CDMO, Natural Extracts, Third-party Services, Pharmaceutical Machinery, API Equipment, Packaging Equipment, Cleanroom Equipment and Engineering, Laboratory Construction and Systems, etc. About CPHI & PMEC China： CPHI & PMEC China (Shenzhen) continues to focus on the pharmaceutical industry development in the Guangdong-Hong Kong-Macao Greater Bay Area, radiating the Asian market, and concentrating on the transformation and upgrading of new drug development, technological innovation, and other fields. It aims to create a more precise, professional, and technology-driven industrial upgrading platform, deeply connecting the industrial exchanges and cooperation in the Guangdong-Hong Kong-Macao Greater Bay Area and even Asia.
- Source: drugdu
- 88
- April 17, 2025
Merck’s 9-valent HPV vaccine has been approved for marketing in men; New Hecheng’s net profit increased by 117.01% year-on-year |

NO.1 New Novartis ADC drugs approved for clinical trials in the United States On April 14th, Novo Nordisk announced that its controlling subsidiary, Jushi Bio, has recently received a notification from the US Food and Drug Administration (FDA) that its clinical trial application for injectable SYS6041 drug, filed by Jushi Bio, has been approved by the FDA and can be conducted in the United States. SYS6041 is a monoclonal antibody conjugated drug (ADC) that can bind to specific receptors on the surface of tumors, enter cells through endocytosis, and release toxins, achieving the effect of killing tumor cells. The clinical indication approved this time is advanced solid tumor. Comment: This event is an important breakthrough in the company’s internationalization research and development process, which not only enhances the company’s market attention in the field of innovative drugs, but also brings potential opportunities for future performance growth. However, given the ...
- Source: drugdu
- 106
- April 16, 2025
Intravenous human immunoglobulin (IVIG) is in the drug approval stage

Hualan Bio said on the interactive platform on April 14 that the company’s intravenous human immunoglobulin (IVIG) (5%, 10%) has completed Phase III clinical research and submitted a drug registration and marketing authorization application to the National Drug Administration and has been accepted, and is in the drug approval stage; human coagulation factor IX (FIX) is conducting Phase III clinical research; Exendin-4-FC fusion protein project has completed Phase I clinical trials and is conducting Phase II clinical trials; the vaccine company is steadily carrying out preclinical research and development of recombinant herpes zoster vaccine (CHO cells), mRNA influenza virus vaccine, mRNA respiratory syncytial virus (RSV) vaccine, and poxvirus broad-spectrum influenza; freeze-dried group A and group C meningococcal conjugate vaccine has completed Phase III Phase III clinical trials are underway for Hib conjugate vaccine, which was submitted for clinical trials in December 2024 and accepted; Phase III clinical trials are underway ...
- Source: drugdu
- 90
- April 16, 2025
Implement penetrating supervision on medical institutions’ practices, drug and equipment circulation, and medical insurance fund use

Shanghai Municipal Party Committee Deputy Secretary and Mayor Gong Zheng presided over the executive meeting of the municipal government on April 14. The meeting pointed out that new forms and models of medical and health services are constantly emerging. It is necessary to improve the comprehensive supervision system of the medical and health industry, deepen comprehensive supervision with a strict tone, and shift from post-processing to full-process supervision. Relying on artificial intelligence, big data, blockchain and other technologies, implement penetrating supervision on medical institutions’ practices, drug and equipment circulation, and medical insurance fund use, and effectively protect the legitimate rights and interests of the people. It is necessary to promote innovation and development with a prudent and inclusive attitude, support and standardize the innovative development of new technologies such as medical artificial intelligence and cell therapy, as well as new forms of innovation such as Internet medical care and international ...
- Source: drugdu
- 89
- April 16, 2025
Tianyu shares wholly-owned subsidiary obtains drug registration certificate for pravastatin sodium tablets

On April 14, Tianyu shares (300702) issued an announcement that the company’s wholly-owned subsidiary Nord Pharmaceuticals recently received the “Drug Registration Certificate” for pravastatin sodium tablets approved and issued by the State Drug Administration. The drug dosage form is tablets with a specification of 40mg. It belongs to Class 4 chemical drugs. The drug approval number is National Medicine Standard H20253858, and the approval period is until April 7, 2030. It is suitable for hyperlipidemia and familial hypercholesterolemia. According to market data, the sales of pravastatin sodium tablets in domestic sample hospitals and urban physical pharmacies in 2023 are about 1.024 billion yuan. As of March 31, 2025, the company and its subsidiaries have invested approximately 9.26 million yuan in research and development on this drug. The announcement pointed out that the acquisition of the drug registration certificate will further enrich the company’s preparation varieties and specifications, and is expected ...
- Source: drugdu
- 86
- April 16, 2025
The nine-valent HPV vaccine for men is now available

After the four-valent HPV (human papillomavirus) vaccine was opened to men, on April 14, Merck China announced that Gardasil® 9 [nine-valent human papillomavirus vaccine (brewer’s yeast)] (hereinafter referred to as “nine-valent HPV vaccine”) has been approved for marketing by the National Medical Products Administration for multiple new indications and is suitable for males aged 16 to 26. This means that China has ushered in the first nine-valent HPV vaccine that can be used for male vaccination. Gardasil® 9 has become the first and currently the only approved nine-valent HPV vaccine in China that can be used for males and females of appropriate age, marking that China has officially entered a new stage of “joint prevention of HPV-related cancers and diseases for both men and women”. Although men do not develop cervical cancer, they are the main carriers of HPV virus. Globally, the male genital HPV infection rate is higher than ...
- Source: drugdu
- 118
- April 16, 2025
【EXPERT Q&A】What are the procedures and qualifications required for the export of domestic drugs to East Africa?

Drugdu.com expert’s response: Export Process and Qualification Requirements for Chinese Pharmaceutical Products to East Africa (2025 Update) Based on the latest East African Community (EAC) pharmaceutical regulations and China’s White Paper on Medical Exports to Africa: I. Pre-Qualification Preparation (3–6 Months) Production Compliance: 2025 China GMP Certification: Mandatory adoption of quantum-encrypted traceability modules for data integrity. Submit 36-month stability test reports under tropical conditions (40°C/75% humidity). WHO Prequalification (PQ): Required for antimalarial/HIV drugs in EAC public tenders. Review周期缩短至4.2 months (30% faster than 2020). Export Documentation Free Sale Certificate (FSC): Issued by provincial authorities, apostilled, and blockchain-verified (recognized by Kenya Revenue Authority). Religious Compliance: Halal certification (EAC Islamic Affairs Council) for animal-derived ingredients; separate approval for alcohol-based formulations. II. EAC Regional Market Access Centralized EAC Review (Core Step) MRH-01 Dossier Submission: Include multi-country clinical trial data (minimum 2 EAC nations, e.g., Rwanda’s Kigali University Hospital). Localized bilingual packaging (English/Swahili + Braille). Fast-Track Eligibility: 50% faster review for drugs in the China-Africa Public ...
- Source: drugdu
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- April 16, 2025
2025 Wuzhen Health Conference | Tasly Achieves Multiple Awards, Driving a New Future of Medicine and Health with Innovation

From April 8th to 12th, 2025, Wuzhen, a water town in Jiangnan, welcomed the annual grand event in the field of medicine and health – Wuzhen Health Conference. This industry grand event, which gathers industry elites, experts, scholars, and well-known enterprises, is an important platform for gaining insights into industry trends and exchanging innovative ideas. Tianshili Pharmaceutical Group (hereinafter referred to as “Tianshili”) won multiple awards at the conference with innovative achievements in brand strategy, product positioning, market channels, and other aspects, becoming the focus of the audience. Brand Strategy Innovation: Shaping the Influence of Innovative Traditional Chinese Medicine Drugs In terms of brand strategy, Tasly always regards innovation as the core driving force and is committed to building a Chinese medicine brand with international influence. Winning the title of “VIP Strategic Cooperation Enterprise” at the 2025 Wuzhen Health Conference is a high recognition of its brand strength and ...
- Source: drugdu
- 67
- April 15, 2025
Boya Biotechnology plans to list and transfer 80% equity of its subsidiary; Two drugs from Hengrui Pharmaceutical have been approved for clinical trials | Medical Early Reference

NO.1 Boya Biotechnology plans to publicly list and transfer 80% equity of its subsidiary On April 13th, Boya Biotechnology announced its intention to transfer 80% equity of Jiangxi Boya Xinhe Pharmaceutical Co., Ltd. (referred to as “Boya Xinhe”) through listing on the Shanghai United Property Rights Exchange, with an initial listing amount of approximately 213 million yuan. Boya Xinhe was established in 2014, and its main business is the R&D, production and sales of anti infection, diabetes, cardio cerebrovascular drugs. After the equity transfer, the company holds 10.6869% of the equity of Boya Xinhe, and its wholly-owned subsidiary Jiangxi Boya Pharmaceutical Investment Co., Ltd. holds 9.3131% of the equity of Boya Xinhe. Boya Xi nhe will no longer be included in the company’s consolidated statements. Comment: From January to December 2024, Boya Xinhe’s operating revenue was 10.1729 million yuan, total profit was -34.6187 million yuan, and net profit was ...
- Source: drugdu
- 54
- April 15, 2025

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