Pharmaceutical News of the Week (June. 29th-July. 3rd) | PharmaSources.com - Updates on Approvals

Let’s review the hot events of the pharmaceutical industry this week. The news involved 5 sections: approval, R&D, policies, transactions and listing that happened during June 29-July 3, including 29 pieces.

Approval

NMPA

1. Luye Pharma announced on June 29 that the clinical trial application for lurbinectedin, an  innovative anti-tumor drug, introduced by it from the Spanish company: PharmaMar was accepted by the CDE for the treatment of small cell lung cancer (SCLC). As an inhibitor of RNA polymerase II, lurbinectedin has received the FDA’s accelerated approval for marketing in the U.S. this June for the treatment of adult patients with relapsed SCLC whose disease has progressed on or after platinum-based chemotherapy.

2. HEC’s marketing application for Class 3 generic drug: Oseltamivir Phosphate for Oral Suspension was accepted by the CDE on June 29, making it the third manufacturer applying for the marketing of the dosage form in China following BrightGene Pharmaceutical and Brilliant Pharmaceuticals.

3. Aosaikang’s marketing application for Class 4 generic drug: Eltrombopag Olamine Tablets was accepted by the CDE on June 29, making it the first manufacturer applying for the marketing of the generic drug in China. As a TPO-R agonist developed by Novartis, the original drug is indicated for the treatment of patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids or immunoglobulins, etc.; it was approved by the FDA for marketing in Nov. 2008 and entered the Chinese market in Dec. 2017.

4. Kelun Pharmaceutical’s Class 4 generic drug: Tofacitinib Citrate Tablets was approved by the NMPA for marketing on June 30 and deemed as passing the consistency evaluation, making it the 3rd enterprise in passing the consistency evaluation of the variety in China following Chiatai Tianqing and Qilu Pharmaceutical. Developed by Pfizer, tofacitinib was approved by the FDA in Nov. 2012 and approved in China in Mar. 2017. The drug is one of the important varieties in the centralized procurement of the 3rd batch of drugs organized by China, and Kelun Pharmaceutical has become a strong competitor in providing the drug.

5. Salubris’ clinical trial applications for 2 new drugs (enarodustat tablets, and recombinant human neuregulin-1-anti-HER3 antibody fusion protein for injection) were accepted by the CDE on June 30.

6. JW Therapeutics’ marketing application for JWCAR029 was accepted by the CDE on June 30, which is the 2nd CAR-T therapy applied for marketing in China following the Fosun Kite’s axicabtagene ciloleucel.

7. The clinical trial application filed by Amgen/BeiGene for AMG910 was accepted by the CDE on July 1. The drug is currently in a global phase 1 clinical trial for gastric and gastroesophageal junction adenocarcinoma. AMG910 is an anti-CD3/CLDN18.2 bispecific antibody, while CLDN18.2 is a protein encoded by the CLDN18 gene, belongs to the claudin family and can control the flow of molecules between cells in a layer.

8. Hengrui announced on July 1 that the clinical trial applications for its 2 Class 1 new drugs: HRS5091 tablets and HRS9950 tablets were approved by the NMPA, both of which will be used to treat chronic hepatitis B.

9. Yuxi Zerun Biotechnology’s marketing application for the Recombinant Human Papillomavirus Bivalent (Type 16/18) Vaccine (Yeast) was accepted by the CDE on July 1, marking the production application for the second Chinese-produced bivalent HPV vaccine. The company is expected to be a new competitor in the Chinese-produced HPV vaccines.

10. BeiGene announced on July 2 that the CDE accepted its marketing application (sNDA) for the new indication of tislelizumab injection, its anti-PD-1 monoclonal antibody, for treating patients with unresectable hepatocellular carcinoma (HCC) who have received prior therapy.

11. Chiatai Tianqing’s Class 4 generic drug: Clopidogrel Bisulfate Tablet (trade name: Youliwei) received the marketing approval of the NMPA on July 2 and was deemed as passing the consistency evaluation, making the company the 4th in passing the consistency evaluation of the variety in China.

FDA

12. According to a warning letter issued by the FDA on June 29, the website of the company: Super Health Guard and Loyal Great located in Hong Kong, S.A.R., China, China has sold Lianhua Qingwen Capsules directly to the U.S. and directly labeled content such as “intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people” on the product, which is misleading.

13. Intercept announced on June 29 that the marketing application for obeticholic acid (OCA) for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH) was rejected by the FDA (through a Compete Response Letter (CRL)). Affected by the announcement, Intercept’s stock price slumped by 38% in the pre-market trading, with USD1 billion lost in market capitalization, to decline from USD2.5 billion to USD1.5 billion.

14. Merck and Pfizer announced on June 30 that the FDA approved the supplemental Biologics License Application (sBLA) for Bavencio (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

15. On June 30, the FDA approved the marketing of Phesgo (pertuzumab/trastuzumab /hyaluronidase–zzxf), an antibody cocktail therapy, developed by Roche for subcutaneous injection for the treatment of adult patients with HER2-positive metastatic breast cancer and early-stage HER2-positive breast cancer. The approval date was nearly 4 months earlier than the scheduled Oct. 18.

16. On June 30, the FDA’s Center for Biologics Evaluation and Research (CBER) issued the Guidance for Industry: Development and Licensure of Vaccines to Prevent COVID-19 to help bio-medicine enterprises with the clinical development of vaccines to prevent COVID-19 and the registration approval thereof by regulators. Wherein, a core point is that the FDA requires the marketed vaccines to prevent COVID-19 should be at least 50% more effective than placebos.

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Pharmaceutical News of the Week (June. 29th-July. 3rd) | PharmaSources.com - Updates on Policies

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