Novo Nordisk Faces U.S. Senate Scrutiny Over High Pricing of Weight-Loss Drugs; J&J’s EGFR/c-MET Bispecific Antibody Gains Additional FDA Approval
Johnson & Johnson
Medical Device R&D and Manufacturer
Winner Medical
Service Provider in the Field of Medical Supplies and Doctor Dressings
Allist Pharmaceuticals
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ANTENGENE CORPORATION
Innovative Oncology Drug Developer
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Author | Huang Kai
Novo Nordisk Faces U.S. Senate Inquiry Over Weight-Loss Drug Pricing.
On September 23, the U.S. Senate website showed that the U.S. Senate would hold a hearing on September 24 local time to review whether Novo Nordisk has provided overly expensive semaglutide products Ozempic and Wegovy for patients with diabetes and obesity.
Johnson & Johnson's EGFR/c-MET Bispecific Antibody Receives Another Approval.
On September 20, Johnson & Johnson announced that the FDA had approved its EGFR/c-MET bispecific antibody Rybrevant in combination with standard chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC who have progressed during or after treatment with EGFR-TKI and have EGFR exon 19 deletion or L858R substitution mutations.
Winner Medical's Overseas Mergers and Acquisitions.
On September 23, Winner Medical announced that, in order to create a one-stop solution for global medical consumables, improve the global production and logistics layout, build local operational capabilities in the United States and Europe, enrich the product line, and strengthen R&D capabilities, the company acquired 75.2% of GRI's equity in cash. The corresponding transaction price was approximately US$120 million. The equity transfer procedures were completed on September 20, 2024.
In the past day, what are the hotspots in the pharmaceutical market at home and abroad that are worth paying attention to? Let Amino take you to explore.
/ 01 /
Market Express
1) Winner Medical Acquires 75.2% Stake in GRI for $120 Million
On September 23, Winner Medical announced that, in order to create a one-stop solution for global medical consumables, improve the global production and logistics layout, build local operational capabilities in the United States and Europe, enrich product lines, and strengthen R&D capabilities, the company acquired 75.2% of GRI's equity in cash form, with the corresponding transaction consideration being approximately US$120 million. The equity transfer procedures for the transaction were completed on September 20, 2024.
/ 02 /
Pharmaceutical News
1) Allist Pharmaceuticals' AST2303 Tablets Receive Clinical Approval
On September 23, according to the CDE official website, Allist Pharmaceuticals' AST2303 tablet received clinical approval and is intended for use in adult patients with advanced non-small cell lung cancer carrying the EGFR C797S mutation.
2) Positive Results from Insilico Medicine's ISM001-055 Phase IIa Clinical Trial
On September 19, Insilico Medicine announced positive results from the Phase IIa clinical trial of its AI drug ISM001-055. The data showed good safety and a dose-dependent efficacy trend.
3) ANTENGENE CORPORATION's Xpovio Approved for Marketing in Thailand
On September 23, ANTENGENE CORPORATION announced that the Thai Food and Drug Administration had approved the New Drug Application (NDA) for Xpovio, for the treatment of two indications.
4) FDA Approves Phase II Clinical Trial Application for Fangto Bio's FT-002 Injection
On September 21, Fount Bio announced that the FDA has approved the Phase II clinical trial application for its recombinant adeno-associated virus gene therapy product FT-002 injection, which is intended to treat X-linked retinitis pigmentosa (XLRP) caused by RPGR gene mutations.
5) Novartis' Iptacopan proposed for priority review
On September 23, according to the CDE official website, Novartis' Iptacopan Hydrochloride Capsules new indication application is proposed to be included in the priority review, applicable for the treatment of adult patients with C3 Glomerulopathy (C3G).
6) Fudan Zhangjiang's Hemoporfin for Injection Completes First Patient Enrollment in U.S. Phase II Clinical Trial for Port-Wine Stains
On September 23, Fudan Zhangjiang announced that the Phase II clinical trial of Hemoporfin for Injection, used for treating port-wine stains, successfully enrolled the first participant in the United States.
7) Cytokinetics' Aficamten Tablets Proposed for Priority Review
On September 23, according to the CDE website, Jixing Pharma's Aficamten Tablets are proposed for inclusion in the priority review, intended for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
/ 03 /
Instrument Tracking
1) Acotec's RunFlow® Cardiac Valve Balloon Dilation Catheter Approved for Marketing by NMPA
On September 19, Acotec's cardiac valve balloon dilation catheter RunFlow® received NMPA approval for marketing.
2) Heartpulse Medical Obtains Medical Device Registration Certificates for Two Products
On September 23, Heartpulse Medical announced that its controlling subsidiary obtained the medical device registration certificate for the fiber-haired embolic coil. Meanwhile, the peripheral stent system BioMimics 3D Stent System, a product of Veryan Medical Ltd. which the company acts as an agent for, also received the medical device registration certificate.
3) Well Lead Medical's balloon dilation catheter has obtained certification from Health Canada.
On September 23, Well Lead Medical announced that the company had recently received a Class 2 medical device product registration certificate issued by Health Canada. The company's product, balloon dilation catheter, has obtained certification from Health Canada.
/ 04 /
Digital Healthcare Daily
1) JD.com and Alibaba Join Hands with Dayin Pharmaceutical to Build and Share Digital Health
Recently, Dayin Pharmaceutical signed strategic cooperation agreements with two major platforms, Alibaba Health Pharmacy and JD Health, to explore the future development of digital health for pediatric medications.
/ 05 /
Overseas Pharmaceutical News
1) Novo Nordisk Faces U.S. Senate Inquiry Over Weight-Loss Drug Pricing
On September 23, the U.S. Senate website showed that the U.S. Senate would hold a hearing on September 24 local time to review whether Novo Nordisk provides overpriced semaglutide products Ozempic and Wegovy for patients with diabetes and obesity.
2) Johnson & Johnson's EGFR/c-MET Bispecific Antibody Receives Another Approval
On September 20, Johnson & Johnson announced that the FDA had approved its EGFR/c-MET bispecific antibody Rybrevant in combination with standard chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC who have progressed during or after EGFR-TKI therapy and harbor EGFR exon 19 deletion or L858R substitution mutations.
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