PharmaFocus Today – Page 14 – media

Enhertu received approval for its fifth indication in the country; the FDA approved the world’s first MASP-2 antibody

Enhertu has been approved in the country one after another. On December 25, Daiichi Sankyo announced that its blockbuster HER2 ADC drug, trastuzumab (Enhertu®), co-developed with AstraZeneca, has been approved for marketing in China for a new indication: adult patients with HR-positive, HER2-low expression (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low expression (IHC 0, with membrane staining) breast cancer. New developments in FDA approvals. On December 24, the FDA approved Narsoplimab from Omeros, the first MASP-2 antibody, for the treatment of thrombotic microangiopathy associated with hematopoietic stem cell transplantation (TA-TMA). What other hot topics in the domestic and international pharmaceutical markets were worth noting in the past day? Let Amino Jun take you to find out. / 01 / Market Express 1) Enhua Pharmaceutical and Luye Pharma reach an agreement for the domestic commercialization of three psychiatric drugs. On December 24, Enhua Pharmaceutical announced a strategic cooperation agreement with Luye ...
- Source: drugdu
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- December 26, 2025
Reinforcing Efficacy Both as Monotherapy and in Combination with Abemaciclib in Patients with ER+, HER2- Advanced Breast Cancer

December 12, 2025 — Eli Lilly and Company announced updated results from the Phase 3 EMBER-3 clinical trial of the oral estrogen receptor antagonist imlunestrant. The study enrolled patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–) advanced or metastatic breast cancer (MBC) who had experienced disease progression after prior treatment with an aromatase inhibitor (AI) with or without a CDK4/6 inhibitor. Compared to endocrine therapy, imlunestrant monotherapy demonstrated a clinically meaningful 38% reduction in the risk of disease progression or death in patients with an ESR1 mutation (median progression-free survival (PFS): 5.5 months vs. 3.8 months; HR = 0.62; 95% CI: 0.47–0.82; nominal p = 0.0007). It also extended median overall survival (OS) by 11.4 months (34.5 months vs. 23.1 months; HR = 0.60; 95% CI: 0.43–0.86; p = 0.0043, did not meet the prespecified threshold for statistical significance). Among all patients, imlunestrant in combination with ...
- Source: drugdu
- 61
- December 26, 2025
HIV Antibody Oral Mucosal Transudate Self-Testing Kit Obtains Medical Device Registration Certificate

People’s Finance News, December 25 – Wantai Biotech (603392) announced on December 25 that its self-developed HIV (Type 1+2) Antibody Oral Mucosal Transudate Testing Kit (Colloidal Gold Method) has obtained the “Medical Device Registration Certificate (In Vitro Diagnostic Reagent)” issued by the National Medical Products Administration (NMPA). Additionally, the clinical trial application for the “Recombinant Trivalent Rotavirus Subunit Vaccine (Escherichia coli)”, submitted by its wholly-owned subsidiary Xiamen Wantai Kangtai Biotech Co., Ltd., has been accepted for review by the NMPA. Reference：https://finance.eastmoney.com/a/202512253601917149.html
- Source: drugdu
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- December 26, 2025
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
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

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