media – Page 30 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Pfizer loses out in hemophilia

For Pfizer, which has suffered a major setback in the field of gene therapy, the year 2025, which is about to end, has indeed been incredibly difficult. Now, the giant faces further troubles in the field of next-generation therapies, which are seen as potential successors. On December 14, a patient who participated in the long-term extended study of Pfizer’s new hemophilia drug Hympavzi died from cerebellar infarction followed by cerebral hemorrhage. This patient, suffering from hemophilia A and on inhibitors, underwent minor surgery and was routinely using the experimental drug Hympavzi for prophylaxis, as well as recombinant coagulation factor VIIa for perioperative hemostasis management. Tragically, the incident occurred a few days later. The exact reasons are still under investigation. Pfizer quickly initiated a review with researchers and an independent data monitoring committee, and notified regulatory agencies. However, the patient’s death is like a boulder thrown into a lake in the ...
- Source: drugdu
- 80
- December 26, 2025
Maiwei Biotech’s new monoclonal antibody drug has received FDA approval to begin Phase 2a clinical trials for COPD

On December 24, Maiwei Bio announced that its independently developed anti-ST2 monoclonal antibody innovative drug (development code: 9MW1911) has officially received approval from the US FDA for clinical trials, which can be used to conduct phase 2a clinical studies for moderate to severe chronic obstructive pulmonary disease (COPD) . 9MW1911 binds to the ST2 receptor with high affinity, thereby blocking the IL33/ST2 signaling pathway. This drug has completed a Phase 2a clinical trial (N=80) in China for patients with moderate to severe COPD, and the results showed: Compared with placebo (N=20), the study was safe and well-tolerated in all dose groups, with an overall adverse event rate similar to that in the placebo group (70% vs 85%). All subjects were immunogenic and no new safety risk signals were identified. Pharmacokinetic results suggest that drug exposure increases with increasing dose, and the exposure-response model can preliminarily establish a dose-response relationship, providing ...
- Source: drugdu
- 92
- December 26, 2025
Gravel Biotech’s next-generation gene knockout TIL product GT307 injection receives FDA IND approval in the United States

On December 23, 2025, GT307 injection , a next-generation gene-knockout tumor-infiltrating lymphocyte (TIL) product independently developed by Sapphire Biotech , received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) . This marks another significant milestone for Sapphire Biotech in the field of high-safety gene-edited TILs, following the completion of clinical trial applications for its GT201 product in China and the United States. It also signifies that multiple cell therapy pipelines of the company have entered the clinical stage in the United States. GT307 is a next-generation dual-gene knockout TIL product based on CRISPR gene editing technology, designed to address key bottlenecks in traditional TILs, such as functional exhaustion and insufficient persistence in the tumor microenvironment. Leveraging the ImmuT Finder® high-throughput immunomodulatory target screening platform independently developed by SandGrey Biotech, the company systematically discovered and identified key immunomodulatory factors that inhibit the anti-tumor function of TILs, ...
- Source: drugdu
- 104
- December 26, 2025
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
- 79
- 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
- 79
- 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
- 71
- 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
- 85
- 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
- 83
- December 25, 2025

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