Gilead's CD47 Monoclonal Antibody Clinical Trial Was 'Unblocked' By FDA

1. Merck announced that the FDA has granted its 21-valent pneumonia vaccine V116 breakthrough therapy designation for the prevention of pneumococcal infection and bacterial pneumonia in adults 18 years of age and older.

2. Gilead announced that the U.S. FDA has canceled the partial clinical suspension of its investigational CD47 monoclonal antibody magrolimab combined with azacitidine. The FDA lifted some partial clinical suspensions after reviewing comprehensive safety data from each clinical study. magrolimab, a monoclonal antibody that blocks CD47 signaling, was acquired by Gilead after acquiring Forty Seven for about $4.9 billion in April 2020.

3. Regeneron said that the U.S. FDA has extended the review period for REGEN-COV's biologics license application for the treatment of COVID-19 in non-hospitalized patients and as a preventive measure for certain individuals by three months to July 13. REGEN-COV had previously been put on hold in the U.S. for Omicron, and now the drug is having trouble seeking full approval from the U.S. FDA.

4. Hengrui Medicine announced that the abbreviated new drug application for gadoteric acid meglumine injection submitted by Hengrui to the US FDA has been approved. Gadoterate Meglumine Injection is a gadolinium-based intravenous contrast agent used for MRI of the brain (intracranial), spine, and related tissues in adults and children (including neonates) to examine blood-brain barrier damage and vascular abnormalities .

5. Junshi Bio's anti-PD-1 monoclonal antibody toripalimab was granted orphan drug designation by the FDA for the treatment of small cell lung cancer, which is the fifth orphan drug designation obtained by toripalimab .

6. Haisco issued an announcement stating that the company's HSK29116 new drug clinical trial application submitted to the US FDA was recently approved by the FDA. HSK29116 is an oral PROTAC small molecule antitumor drug targeting BTK independently developed by Hisco. It is used for the treatment of relapsed and refractory B-cell lymphoma. It is the first BTK-PROTAC drug in China and the second in the world to enter clinical research.

7. Connoya Bio released a press release stating that its core product, CMG901, an antibody-drug conjugate (ADC) targeting Claudin 18.2, has been granted orphan drug status by the U.S. FDA for the treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma. CMG901 has been approved by the FDA to conduct Phase 1 clinical trials for advanced gastric cancer and gastroesophageal junction adenocarcinoma.

8. Jianyou Co., Ltd. announced that its subsidiary Hong Kong Jianyou recently received the approval letter for Reganosson Injection, 0.4mg/5mL (0.08mg/mL) issued by the US FDA. As a loading drug used in radionuclide myocardial perfusion imaging, this product is suitable for patients who cannot accept exercise stress test but need to undergo drug stress test.

9. The FDA issued an Emergency Use Authorization (EUA) for the first COVID-19 diagnostic test that can detect compounds in breath samples associated with SARS-CoV-2 infection, in settings where patient samples are collected and analyzed Conducted, such as in doctor's offices, hospitals, and mobile testing sites, using an instrument approximately the size of a piece of hand luggage.