RSV Vaccines Face New FDA Warnings Over GBS Risk; Consero Pharma Inks Licensing Deal for Alzheimer’s Oral Drug ZUNVEYL
GSK
Pharmaceutical R&D Manufacturer
CMS
Professional Drug Developer
Gloria Pharmaceuticals
Pharmaceutical R&D Developer
OCULGEN
Large Molecule Ophthalmic Innovation Drug Developer
Sanofi
Pharmaceutical Manufacturer
Double Medical
Developer and Manufacturer of High-Value Medical Consumables
United Imaging
High-end Medical Device Developer
Amino Observation - Original Production by the Innovative Drug Team
Author | Huang Kai
RSV Vaccine Faces Another "Setback".
Recently, the FDA issued an announcement requiring Pfizer and GSK to modify the labels of their approved RSV vaccines to include a new warning about the risk of Guillain-Barré Syndrome.
CSO enterprises are going further and further down the road of pharmaceuticals.
On January 8, CMS announced that through its wholly-owned subsidiary, it had entered into a licensing, collaboration, and distribution agreement with Alpha Cognition for ZUNVEYL, a modified new drug for the treatment of mild to moderate Alzheimer's type dementia symptoms. CMS obtained exclusive rights to develop, register, manufacture, import, export, and commercialize the product in Asia (excluding Japan), Australia, and New Zealand, while Alpha Cognition retains the right to manufacture and supply within the region.
In the past day, what are the hot topics in the pharmaceutical markets at home and abroad that are worth paying attention to? Let Aji Jun take you to explore.
/ 01 /
Market Express
1) CMS Introduces an Oral Drug for Alzheimer's Disease
On January 8, CMS announced that through its wholly-owned subsidiary, it had entered into a licensing, collaboration, and distribution agreement with Alpha Cognition for ZUNVEYL, a modified new drug for treating mild to moderate Alzheimer's type dementia symptoms. CMS obtained exclusive rights to develop, register, manufacture, import, export, and commercialize the product in Asia (excluding Japan), Australia, and New Zealand, while Alpha Cognition retains the right to manufacture and supply within the region.
/ 02 /
Capital Information
1) Gloria Pharmaceuticals' Estimated Net Profit for 2024: RMB 210 Million - RMB 250 Million
On January 9, Gloria Pharmaceuticals released its 2024 earnings forecast, expecting a net profit attributable to shareholders of the listed company to be between 210 million yuan and 250 million yuan, representing a year-on-year increase of 74.51%-107.75%.
/ 03 /
Pharmaceutical News
1) OCULGEN's OCUL101 Injection Receives Clinical Approval
On January 9, according to the CDE official website, OCULGEN's OCUL101 injection has been granted clinical approval and is proposed to initiate research for the treatment of diabetic macular edema.
2) Hycure Pharma Completes First Patient Enrollment in HP568 Tablet Clinical Trial in China
On January 9, Hycan Pharma announced that the first patient has been enrolled in the clinical trial of HP568 tablets, an oral estrogen receptor α protein degrader targeted combination drug for the treatment of ER+/HER2- advanced breast cancer.
3) Sanofi's Isatuximab Approved in China for the First Time
On January 9, Sanofi announced that its new hematological oncology drug, CD38 antibody Isatuximab, has been approved for marketing in China. The approved indication is for use in combination with pomalidomide and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy (including lenalidomide and proteasome inhibitors).
/ 04 /
Instrument Tracking
1) Double Medical's 3D-Printed Artificial Vertebrae Receives Registration Approval
On January 9, according to the NMPA website, Double Medical's 3D-printed artificial vertebral body received registration approval.
2) United Imaging's Magnetic Resonance Imaging System Receives Registration Approval
On January 9, according to the NMPA website, United Imaging's magnetic resonance imaging system received registration approval.
/ 05 /
Digital Healthcare Daily
1) OCULGEN's AI-based Diabetic Retinopathy Fundus Image Auxiliary Diagnosis Software Receives Registration Approval
On January 9, according to the NMPA website, OCULGEN's AI-based software for auxiliary diagnosis of diabetic retinopathy using fundus images received registration approval.
2) ViTele Health's Diabetic Retinopathy Fundus Image Auxiliary Diagnosis Software Receives Registration Approval
On January 9, according to the NMPA website, ViEye's Diabetic Retinopathy Fundus Image Auxiliary Diagnosis Software obtained registration approval.
/ 06 /
Overseas Pharmaceutical News
1) RSV Vaccine Required to Add Risk Warning
Recently, the FDA announced that Pfizer and GSK are required to modify the labels of their approved RSV vaccines to include a new warning about the risk of Guillain-Barré Syndrome.
2) GSK Plans $1 Billion Acquisition of IDRx
Recently, according to overseas media reports, GSK is in advanced negotiations to acquire IDRx, a private biotechnology company focused on developing treatments for rare tumors. According to the Financial Times, citing sources close to the talks, the deal is valued at approximately $1 billion.
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