media – Page 7 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

21 Health News Daily | Yuheng Pharmaceutical and Xinghe Pharmaceutical signed a promotion agreement; Shareholders of Chengdu Pioneer and Aojing Medical reduce their holdings

Policy Tendence The National Medical Products Administration issued a document requiring the implementation of the “Quality Management Standards for Medical Device Network Sales” On May 26th, the National Medical Products Administration announced that the “Quality Management Standards for Online Sales of Medical Devices” (hereinafter referred to as the “Standards”) will officially come into effect on October 1, 2025. Drug regulatory departments at all levels should guide online sales operators and e-commerce platform operators to actively carry out internal training and assessment, focusing on the comprehensiveness of the quality management system coverage of online sales operators, the standardization of product information display, the completeness of online sales related records, as well as the establishment of full process quality management records, verification and updating of network operator files, and the monitoring and risk consultation of medical device quality and safety risks within the platform. Enterprises should conduct key self inspections. Medical device ...
- Source: drugdu
- 58
- May 28, 2025
Kexing Biotech’s wholly-owned subsidiary is approved to conduct clinical trials of GB18 injection

On May 26, Kexing Pharmaceuticals issued an announcement that recently, the company’s wholly-owned subsidiary Shenzhen Kexing Pharmaceutical Co., Ltd. received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, approving it to conduct clinical trials of “GB18 Injection”. The injection is an innovative drug targeting GDF15, designed to treat tumor cachexia. Preclinical data show that GB18 injection has obvious differentiated advantages, can effectively reverse weight loss caused by tumor cachexia, and improve muscle and fat quality. In the first quarter of 2025, Kexing Biotech achieved revenue of 354 million yuan and net profit attributable to shareholders of the parent company of 25.58 million yuan. https://finance.eastmoney.com/a/202505263414629127.html
- Source: drugdu
- 52
- May 28, 2025
Angel Yeast plans to invest 230 million yuan to develop serum-free cell culture medium technology

May 26, Angel Yeast issued an announcement that it plans to implement a key technology research project for serum-free cell culture medium. The total investment of the project is estimated at RMB 230 million, aiming to promote the development of the company’s biotechnology and meet the needs of antibodies, vaccines and recombinant proteins. Other biological products The project will explore the existing synthetic biology The pilot platform has been upgraded and renovated to add a serum-free cell culture medium preparation platform and a core raw material refining and purification platform. It is expected to produce 200 tons of dry powder serum-free cell culture medium and 100,000 liters of liquid serum-free cell culture medium annually. The project construction period is expected to be 30 months, and it is scheduled to be put into production in 2027. The funds will come from the company’s own funds. In the first quarter of 2025, ...
- Source: drugdu
- 52
- May 28, 2025
A new starting point for Hengrui

Hengrui Medicine was founded in 1970. Its predecessor was a small pharmaceutical factory in Lianyungang, Jiangsu (Lianyungang Pharmaceutical Factory). In 1982, Sun Piaoyang joined Lianyungang Pharmaceutical Factory and took office as the new factory director in 1990. Under his leadership, Hengrui Medicine gradually grew from generic drugs to innovative drugs, and became a leader in China’s pharmaceutical field. In 2020, Hengrui Medicine’s market value exceeded 600 billion yuan, driven by innovative products such as carrelizumab. However, with the advancement of national centralized procurement and medical insurance negotiations, Hengrui Medicine’s performance faces severe challenges, and its revenue and net profit have not yet returned to the highs of Q4 2020. The revenue of the generic drug business has shrunk sharply in the past few years, bringing Hengrui Medicine’s performance into its darkest moment, with revenue falling from 27.73 billion yuan in 2020 to 22.82 billion yuan in 2023. In 2024, although ...
- Source: drugdu
- 54
- May 28, 2025
Adjustment of tariff policy on EU

According to a news flash from Xinhua News Agency, US President Trump said on the 25th that he agreed to extend the deadline for imposing a 50% tariff on EU goods to July 9. It is reported that the United States had previously proposed a new “reciprocal tariff” measure in April, wielding the tariff stick at several major trading partners including the European Union, but it also gave a 90-day “deferment period”, which was originally due to end on July 9. However, on May 23rd local time, Trump announced that due to the slow progress of the EU in negotiations and its unfair targeting of US companies through litigation and regulatory means, he would impose a 50% tariff on EU goods from June 1st. This news instantly caused widespread shock in the market, and all parties paid attention to the subsequent development of the situation. Just when the situation seemed ...
- Source: drugdu
- 46
- May 28, 2025
【EXPERT Q&A】Do domestic Class II medical devices need to be registered in the ASEAN countries where they are exported?

Drugdu.com expert’s response: Domestic Class II medical devices exported from China to ASEAN countries generally require registration in the target country, although specific requirements vary depending on each country’s regulations and the risk classification of the product. Below is a detailed analysis: I. Overview of Medical Device Registration Requirements in ASEAN Countries ASEAN countries, including Singapore, Malaysia, Thailand, Indonesia, the Philippines, Vietnam, etc., have varying regulatory requirements for medical devices. However, most countries require imported medical devices to be registered or filed in their domestic markets to ensure compliance with local regulations and standards. These requirements typically include submitting product technical documentation, quality inspection reports, clinical trial data (if applicable), etc., and may necessitate completing the registration process through a local authorized representative or importer. II. Country-Specific Requirements Examples Singapore: The regulatory authority for medical devices is the Health Sciences Authority (HSA) of Singapore. Imported medical devices must comply with HSA’s registration ...
- Source: drugdu
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- May 28, 2025
Medical Japan

Organiser: RX Japan Ltd. Time：October 1 – October 3, 2025 address：2-1 Nakase, Mihama-ku, Chiba-shi, Chiba 261-8550, Japan Exhibition hall：Makuhari Messe Nippon Convention Center Product range: Medical Equipment: Medical electronic instruments, ultrasonic instruments, X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, hemodialysis equipment, anesthesia and respiratory equipment, etc.; disposable medical supplies, dressings, and hygiene materials, various surgical instruments. Medical Supplies: Medical electronic instruments, medical ultrasonic instruments, medical X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, equipment and appliances for operating rooms, emergency rooms, and consultation rooms, diagnostic equipment and supplies, disposable medical supplies, medical dressings and hygiene materials, various surgical instruments, medical healthcare equipment and supplies, traditional Chinese medical instruments and rehabilitation appliances, hemodialysis equipment, anesthesia and respiratory equipment, etc.; family health and wellness products, home-use small diagnostic, monitoring, and therapeutic instruments, rehabilitation and physiotherapy instruments and supplies, electronic medical ...
- Source: drugdu
- 66
- May 27, 2025
【EXPERT Q&A】How to handle the filing for Class I medical device products?

Drugdu.com expert’s response: The process and requirements for filing Class I medical device products are as follows: I. Filing Process Determine Product Category: Confirm whether the product falls under Class I medical devices by cross-referencing with the “Class I Medical Device Product Catalog” or the “In Vitro Diagnostic Reagent Classification Catalog”. Ensure that the product name, intended use, product description, etc., align with the catalog’s scope. If the product is not listed in the catalog, an application for medical device classification determination must be submitted first. Once it is clarified as a Class I medical device, filing can proceed. Prepare Filing Materials Submit complete filing materials, including but not limited to: Filing Form: Completed and accompanied by an electronic document, requiring the filer’s signature and seal. Safety Risk Analysis Report: Prepared in accordance with the YY 0316 standard, covering the product’s intended use, hazard identification, risk control measures, and validation results. ...
- Source: drugdu
- 61
- May 26, 2025
Health Daily | Rongchang Biotechnology raises HKD 800 million through placement financing; Biotech adjusts development strategy and terminates a research project

Policy Tendence From January to April 2025, the amount of mutual assistance in employee medical insurance personal accounts was 17.792 billion yuan On May 22nd, the National Healthcare Security Administration announced that the mutual assistance of employee medical insurance personal accounts can be achieved through instant calling of the bound person’s personal account, medical insurance wallet transfer, and other methods. From January to April 2025, the personal accounts of employees’ medical insurance assisted 133 million people, with a total amount of 17.792 billion yuan. From the perspective of mutual aid regions, within the same overall planning area (usually the same city), there were 121 million mutual aid visits and a total mutual aid amount of 15.844 billion yuan; Within the province, there were 11.0188 million cross regional mutual aid visits, with a total amount of 1.914 billion yuan. From the perspective of mutual aid purposes, 15.857 billion yuan was used ...
- Source: drugdu
- 60
- May 26, 2025
Tonghua Dongbao plans to transfer a portion of its shares in Tebao Biotechnology through an agreement; Lizhu Group plans to acquire a portion of the equity of IMP, a Vietnamese pharmaceutical company

NO.1 Biotech adjusts BAT3306 development strategy Biotech announced that after a careful evaluation of the company’s drug supervision and management policies and other factors, it plans to adjust the development strategy of BAT3306 (pembrolizumab) and terminate the ongoing BAT3306-002 study on BAT3306 (an evaluation of the combination of BAT3306 and chemotherapy with Credesia) ® A multicenter, randomized, double-blind phase I/III study on the pharmacokinetics, efficacy, and safety of combination chemotherapy in patients with stage IV non-small cell lung cancer. Comment: Biotech’s adjustment of this research and development strategy is based on the fact that the necessity of efficacy comparison studies has greatly decreased when the European and American drug regulatory authorities approve the marketing application of biosimilar products. However, Biotech stated in the announcement that it will carefully evaluate and make a decision on whether to continue advancing the BAT3306 project in the future, reflecting the current fierce competition in ...
- Source: drugdu
- 62
- May 26, 2025

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