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Wantai Biotech’s Clinical Trial Application for Recombinant Trivalent Rotavirus Subunit Vaccine Accepted for Review

Beijing Business Today – On December 25, Wantai Biotech announced that its wholly-owned subsidiary, Xiamen Wantai Kangtai Biotech Co., Ltd., received the “Acceptance Notice”, an administrative licensing document issued by the National Medical Products Administration (NMPA). The clinical trial application for the company’s “Recombinant Trivalent Rotavirus Subunit Vaccine (Escherichia coli)” has been accepted for review. According to the announcement, this product is a recombinant protein vaccine produced using genetic engineering recombination technology and an Escherichia coli expression system. Its main active component is a truncated rotavirus spike protein VP4. Reference：https://finance.eastmoney.com/a/202512253601968277.html
- Source: drugdu
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- December 26, 2025
Receiving Drug Registration Certificate

Securities Daily News On December 25, Baiyunshan announced that its consolidated entity, Guangzhou Baiyunshan Biological Products Co., Ltd., has received the Drug Registration Certificate for the Freeze-dried Human Rabies Vaccine (Vero Cells) approved and issued by the National Medical Products Administration. reference：https://finance.eastmoney.com/a/202512253602097376.html
- Source: drugdu
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- December 26, 2025
【EXPERT Q&A】What are the considerations to keep in mind when applying for EU CE certification?

Drugdu.com expert’s response: When applying for the EU CE certification, the following considerations should be taken into account to ensure a smooth process and compliance with regulatory requirements: I. Clarify the Scope of Certification and Applicability of Directives Confirm Whether the Product Requires CE Certification: Not all products require CE certification. Only those products that fall within the scope of the EU “CE Directives” or “Regulations” must undergo certification and affix the CE mark. Currently, the EU has issued more than 20 CE-related directives, covering common categories such as electronics and electrical appliances, machinery, medical devices, toys, and building materials. Determine Applicable Directives and Standards: Match the corresponding EU directives (such as the Low Voltage Directive, Electromagnetic Compatibility Directive, Medical Device Regulation, etc.) based on the product type, and verify the latest harmonized standards (such as EN 60335-1 for household appliance safety standards). Avoid invalid certification due to incorrect directive ...
- Source: drugdu
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- December 26, 2025
CoreMedik Unlocks Dual Certifications for Implantation & Intervention of Artificial Heart

Breaking news has just emerged from the artificial heart sector. According to the official website of the National Medical Products Administration (NMPA), CoreMedik’s Interventional Left Ventricular Assist Device and Interventional Left Ventricular Assist Catheter Pump Kit have obtained approval for marketing. This is not only China’s first domestically-developed interventional artificial heart product to secure marketing approval, but also makes CoreMedik the world’s sole enterprise holding regulatory approvals for both implantable and interventional artificial hearts simultaneously. It marks that China’s domestic artificial heart technology has officially joined the world’s leading ranks, bringing a lifeline to a vast number of high-risk cardiovascular disease patients. The NMPA commented: “This system adopts miniaturized axial motor technology for short-term left ventricular support. As an innovative domestic technology, it fills the gap in interventional cardiac assist device technology in China.” Homegrown “Life Pumps” End Overseas Technological Hegemony Homegrown “Life Pumps” End Overseas Technological HegemonyThe approval of ...
- Source: drugdu
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- December 25, 2025
First in over 70 years! New drug for schizophrenia approved in China

On December 23, Zai Lab announced that the NMPA (National Medical Products Administration) has approved its New Drug Application (NDA) for xenometrine trastuzumab capsules for the treatment of schizophrenia in adults . The press release stated that this is the first approved schizophrenia therapy with a novel mechanism of action in over 70 years, representing a fundamental breakthrough in the treatment of schizophrenia.KarXT is an oral combination of an M1/M4 type muscarinic acetylcholine receptor agonist and a muscarinic receptor antagonist. Unlike traditional dopamine-targeting antipsychotics, KarXT affects core disease pathways by selectively acting on muscarinic acetylcholinesteric M1 and M4 receptors in the brain.In November 2021, Zai Lab acquired the development and commercialization rights for KarXT in Greater China (including mainland China, Hong Kong, Macau, and Taiwan) from Karuna Therapeutics for $187 million . In December 2023, BMS acquired Karuna for $14 billion , adding the product to its pipeline.In September 2024, ...
- Source: drugdu
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- December 25, 2025
Is the “anti-aging drug” a scientific breakthrough or a capital game?

On December 23, 2025 , the official WeChat account of Kingdaw Group announced that the β – nicotinamide mononucleotide ( NMN ) raw material produced by its wholly-owned subsidiary, Inner Mongolia Kingdaw Pharmaceutical Co., Ltd., had successfully completed the relevant compliance procedures of the U.S. Food and Drug Administration ( FDA ) regarding New Dietary Ingredient ( NDI ) and obtained an Acknowledgement Letter from the FDA . Completing the above procedures enables Kingdaw’s products to be legally marketed in the United States, and also provides a more solid foundation for Doctor ‘s Best, the company’s US subsidiary , to resume and advance its NMN dietary supplement product portfolio. It’s worth noting that Kingway is not the only company to receive FDA approval. According to information from the domestic synthetic biology company Shangke Biotechnology, on December 2, 2025 , the FDA officially notified Shangke Biotechnology to reinstate its NMN raw ...
- Source: drugdu
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- December 25, 2025
Wegovy oral tablets receive FDA approval, ushering in the “dual-dosage era” for GLP-1 weight-loss drugs

Novo Nordisk dropped a bombshell at the end of 2025. On December 23, the company announced that its daily oral semaglutide tablets (trade name: Wegovy® ) received FDA approval, becoming the world’s first oral GLP-1 receptor agonist for weight management. The product is expected to launch in the US out-of-pocket market in early January 2026, marking a shift in the competition for GLP-1 weight-loss drugs from the injectable era to a “dual-dosage form” era with both oral and injectable options. Image source: Novo Nordisk website Compared to the injectable version, Wegovy tablets have unique requirements regarding administration. Patients must take it daily on an empty stomach, with only a small amount of water, and must not eat, drink, or take other medications for half an hour after taking the medication. This strict administration guideline aims to ensure optimal absorption of the drug in the gastrointestinal tract, but it also places ...
- Source: drugdu
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- December 25, 2025
The leading medical device company’s new venture is aiming for an IPO!

According to recent foreign media reports, Medtronic, the world’s leading medical device company, has entered a critical stage in a major strategic initiative. Medtronic announced that its diabetes business, MiniMed, has filed for an initial public offering (IPO) with the U.S. Securities and Exchange Commission (SEC). Image source: Latest Medical Device News on MassDevice 01 Stripping and splitting Listed on Nasdaq On May 21 this year, Medtronic officially announced its plan to spin off its diabetes business into a new independent publicly traded company, MiniMed, and made it clear that it would prioritize completing this process through an initial public offering (IPO) and subsequent equity divestiture, with all work expected to be completed within the next 18 months. Recently, with Medtronic’s official announcement, this business divestiture process has made substantial progress. MiniMed plans to list on the Nasdaq Stock Exchange under the ticker symbol “MMED,” aiming to raise no more ...
- Source: drugdu
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- December 25, 2025
Patient dies in Pfizer hemophilia drug trial, company issues statement

On December 23 local time, Pfizer Inc. announced that a patient participating in a long-term study of its hemophilia drug had died following severe side effects. Pfizer’s stock closed down more than 1% on the same day. According to the European Haemophilia Consortium, a patient support organization, the patient died on December 14 from a brain hemorrhage following a stroke. The long-term study involved Pfizer’s long-acting hemophilia therapy, Hympavzi. The drug, administered via weekly injections, was approved in the United States last year for the treatment of patients aged 12 and older with hemophilia A or B. It works by targeting specific clotting proteins to prevent or reduce bleeding episodes. Regarding the fatality, Pfizer responded in a statement: “Pfizer, along with trial investigators and an independent external Data Monitoring Committee, is actively gathering information to better understand the complex and multifactorial circumstances surrounding this event.” The company further stated that, ...
- Source: drugdu
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- December 25, 2025
Sanofi to Acquire Dynavax for $2.2 Billion, Strengthening Vaccine Business Portfolio

French pharmaceutical giant Sanofi announced on Wednesday that it will acquire U.S. vaccine company Dynavax Technologies for approximately $2.2 billion (€1.9 billion) in cash. This deal will grant Sanofi access to an approved hepatitis B vaccine. Following the news, Dynavax’s stock surged nearly 40% in early U.S. trading. This year, Sanofi has completed several acquisitions aimed at reducing its reliance on the blockbuster asthma drug Dupixent and diversifying its business. In July, the company acquired British private biotech firm Vicebio for $1.5 billion, shortly after finalizing its acquisition of U.S. rare disease drugmaker BluePrint Medicines, a deal valued at up to $9.5 billion. Under the terms of the agreement, Sanofi will acquire Dynavax for $15.50 per share in cash, representing a 39% premium over its closing price of $11.13 on Tuesday. Sanofi stated that it expects the acquisition to be completed in the first quarter of 2026, with payment to ...
- Source: drugdu
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- December 25, 2025

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