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Four Drugs Included in the 2025 National Medical Insurance Drug Catalogue

Securities Daily Online News – On the evening of December 7, Betta Pharmaceuticals announced that the company’s products, Icotinib Hydrochloride Tablets, Ensartinib Hydrochloride Capsules, Befotnib Mesylate Capsules, and Vorolanib Tablets, have been included in the National Essential Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug Catalogue (2025). https://finance.eastmoney.com/a/202512073584622051.html
- Source: drugdu
- 93
- December 8, 2025
【EXPERT Q&A】What are the differences between medical device verification and medical device validation?

Drugdu.com expert’s response: Medical device verification and validation are two core aspects of quality management. They have fundamental differences in terms of purpose, scope, methods, and application scenarios, yet they complement each other to jointly ensure the safety and effectiveness of products. Here is a detailed comparative analysis: I. Core Purposes Verification: It answers the question “Has the product been made correctly?” by confirming whether the product strictly adheres to design specifications and technical requirements. Key Question: Do the product’s technical parameters, material properties, software functions, etc., align with the design documents? Example: Checking whether the X-ray dose of a CT scanner complies with the safety threshold specified in the design documents. Validation: It answers the question “Has the correct product been made?” by confirming whether the product can meet user needs and intended uses in real-world usage scenarios. Key Question: Is the product safe and effective under actual clinical, ...
- Source: drugdu
- 97
- December 8, 2025
【EXPERT Q&A】What certifications are required for the export of medical products to Malaysia?

Drugdu.com expert’s response: Medical products exported to Malaysia must primarily obtain certification from the Malaysian Medical Device Authority (MDA), with specific requirements varying based on the product’s risk classification (Classes A-D). Here is a detailed explanation: I. Basic Requirements for MDA Certification 1. Corporate Qualifications Local Registration: Companies must register with the Companies Commission of Malaysia (SSM) and obtain a business license. It is recommended to register as a private limited company (Sdn. Bhd.), which allows 100% foreign ownership, provided there is at least one Malaysian director (who does not need to hold shares). Authorized Representative (AR): If the manufacturer is a foreign enterprise, a local Authorized Representative (AR) in Malaysia must be appointed. The AR assists in communication with the MDA and submission of applications. The AR must obtain a Good Distribution Practice for Medical Devices (GDPMD) certificate, issued by an MDA-authorized Conformity Assessment Body (CAB). This certificate is ...
- Source: drugdu
- 122
- December 5, 2025
Breaking the Mold and Forging a New Path! From Insulin Technology Pioneer to Global Innovation Competitor

It’s already spinning like a top… Starting in September, executives from Dongbao Pharmaceutical, based in Tonghua-Beijing, Beijing-Shanghai, and Shanghai-Tonghua, frequently gathered in Tonghua, Jilin Province, during weekend breaks for a series of strategic meetings. Sales targets, annual budget, three-year plan, ten-year vision, resource allocation, organizational arrangements, incentive mechanisms… This “strategic list,” compiled by Chairman Li Jiahong after officially taking over, is backed by a core management team that combines the “industry experience of veterans” with the “innovative vitality of newcomers.” They are driving this 40-year-old company with unprecedented urgency, propelling it onto a new, repeatedly validated path . This waterway carries the past glory of China’s insulin industry and points to the future direction of innovation and transformation for traditional pharmaceutical companies. Like all large-scale traditional pharmaceutical companies that have grown up in the wave of reform and opening up, Dongbao Pharmaceutical’s genes are marked by the times: with its ...
- Source: drugdu
- 217
- December 4, 2025
A subsidiary of Kingfriend Pharmaceutical Co., Ltd. has received FDA approval for its self-developed injectable dapavancin

Recently, Kingfriend Pharmaceutical Co., Ltd.The company announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that its Chengdu subsidiary, Jianjin Pharmaceutical Co., Ltd., has officially approved the injectable dapavancin for sale in the United States. The first batch of products was shipped to the U.S. under controlled conditions in early November. According to reports, dapavancin for injection is primarily used to treat acute bacterial skin and skin structure infections in adults and pediatric patients. Related data shows that in 2024, the drug’s market size in the United States exceeded $250 million, while no similar products have yet been approved in the Chinese market. Kingfriend Pharmaceutical stated that this approval not only further enriches its product pipeline in the US market but also makes Kingfriend Pharmaceutical the first domestic company to obtain international approval for this product. https://finance.eastmoney.com/a/202512023580381538.html
- Source: drugdu
- 108
- December 4, 2025
Major ophthalmic new drug successfully completed Phase III trials

On December 1, Belite Bio announced that its core drug Tinlarebant met its primary endpoint in the pivotal Phase 3 DRAGON trial for the treatment of Stargardt disease type 1 (STGD1). The DRAGON trial is a randomized, double-blind, placebo-controlled global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial recruited 104 participants from 11 countries and regions, including the United States, the United Kingdom, Germany, France, Belgium, Switzerland, the Netherlands, mainland China, Hong Kong, Taiwan, and Australia. Participants were randomly assigned to the Tinlarebant group and the placebo group in a 2:1 ratio. The results showed that, compared with placebo, Tinlarebant reduced the lesion growth rate by 36%, meeting the study’s primary endpoint. After using the pre-defined analysis method, the results were statistically significant (p=0.0033). Considering the progressive nature of STGD1, further post-hoc analysis provided specific data relevance, showing that the ...
- Source: drugdu
- 108
- December 4, 2025
Simcere Pharmaceutical and Wangshan Wangshui have reached an exclusive licensing agreement for deuterium remidevir hydrobromide for new indications such as RSV infection

On December 3, 2025, Simcere Pharmaceutical Group (2096.HK) and Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. (2630.HK) entered into a licensing agreement for deuterium remidevir hydrobromide. Under the agreement, Simcere Pharmaceutical will obtain exclusive licensing rights in Greater China for deuterium remidevir hydrobromide dry suspension for the indications of treating respiratory syncytial virus (RSV) infection and human metapneumovirus (HMPV) infection. This collaboration will further strengthen Simcere Pharmaceutical’s product portfolio in the anti-infective field. Deuterremidevir hydrobromide is an oral nucleoside analogue with broad-spectrum anti-RNA virus potential, exerting its effect by inhibiting viral RNA-dependent RNA polymerase (RdRp). A Phase II clinical trial in China for the treatment of RSV infection in infants (1-24 months) has been completed. Clinical results showed that deuterremidevir hydrobromide dry suspension has good anti-RSV efficacy and safety. Based on the positive results of this clinical trial, deuterremidevir hydrobromide dry suspension received Breakthrough Therapy Designation from the Center for Drug ...
- Source: drugdu
- 139
- December 4, 2025
SAL0140 tablets approved for clinical trials for the treatment of chronic kidney disease

People’s Financial News, December 3, 2025 – Salubris Pharmaceuticals (002294) announced today that the company has received the Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA), agreeing to conduct clinical trials for its independently developed innovative small molecule drug, SAL0140 tablets, for the treatment of chronic kidney disease (CKD). SAL0140 is an aldosterone synthase inhibitor with independent intellectual property rights belonging to the company. The planned indications for development include uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD), among others. https://finance.eastmoney.com/a/202512033581668270.html
- Source: drugdu
- 108
- December 4, 2025
Self-developed innovative drug FXS0887 approved for clinical trials in advanced malignant solid tumors

Zhongzheng Smart Finance News, Fosun Pharma (600196) announced in the evening on December 3, 2025, that its controlling subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (hereinafter referred to as “Fosun Pharma Industrial”), has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its self-developed oral small molecule innovative drug, FXS0887 tablets, for the treatment of advanced malignant solid tumors. Fosun Pharma Industrial plans to initiate Phase I clinical trials in China when conditions are met. According to the announcement, FXS0887 can specifically inhibit the activity of the ATR (Ataxia Telangiectasia and Rad3-related) kinase, thereby inhibiting the malignant proliferation of tumor cells by interfering with cell cycle regulation and DNA damage repair-related pathways. Current preclinical studies have shown that the drug exhibits good antitumor activity in a variety of tumor models, with small off-target risk and good safety. The announcement stated that as of October ...
- Source: drugdu
- 96
- December 4, 2025
15-valent HPV Vaccine Currently in Phase II Clinical Trial Stage

Securities Daily Online – On December 2, Chengda Biotech responded to investor inquiries on the interactive platform, stating that the company’s under-construction Biotech Product R&D and Production Base Project is planned in two phases: Phase I includes facilities such as a production workshop for the 15-valent HPV vaccine, while Phase II consists of standardized biopharmaceutical factory buildings, which will effectively support the industrialization of ongoing R&D projects. Currently, the 15-valent HPV vaccine is in the Phase II clinical trial stage. The vaccine’s R&D, approval process, and project construction are influenced by multiple factors and carry certain uncertainties. The company will promptly disclose any latest developments in accordance with relevant regulations. Reference：https://chat.deepseek.com/a/chat/s/0e718e8d-8f9c-4483-a333-6db4b824d280
- Source: drugdu
- 133
- December 4, 2025

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