Pharmaceutical News of the Week | CPhI.CN - Approval

(July.27th-31th)

NMPA

1. Bio-Thera announced on July 28 that a new indication: Crohn’s disease was approved for its adalimumab injection (trade name: QLETLI) in China.

2. The clinical trial application filed by YZY Biopharma for its recombinant anti-CD38/CD3 bispecific antibody for injection (Y150) was accepted by the CDE on July 28, which is the first Chinese anti-CD38/CD3 bispecific antibody applied for a clinical trial.

3. The marketing application filed by Chongqing YaoPharma for sorafenib tosylate, a Class 4 generic drug, entered the administrative approval stage on July 29, which is expected to be approved soon to become the first generic of the variety in China.

4. Chiatai Tianqing became the first Chinese enterprise in passing the generic drug consistency evaluation of Adefovir Dipivoxil Capsules on July 29. Adefovir dipivoxil is the prodrug of adefovir and a nucleoside/nucleotide anti-HBV drug.

5. Sino Biopharmaceutical announced on July 29 that its Idarubicin Hydrochloride for Injection was approved for the treatment of acute myelogenous leukemia (AML) and deemed as passing the generic drug consistency evaluation in China.

6. Kelun Pharmaceutical’s marketing application for Trelagliptin Succinate Tablets, a Class 3 generic drug, was accepted by the CDE on July 29, and it is the first company applying for the production of the variety in China.

7. Pfizer’s marketing application for Crisaborole Ointment, a new drug for atopic dermatitis, in China was approved on July 29. The drug is listed in the List of the Second Batch of Overseas New Drugs Catering to Clinical Urgent Needs of China, indicated for the treatment of mild to severe atopic dermatitis in patients aged ≥ 2 years.

8. MSD’s marketing application for Ertugliflozin Tablets in China was approved on July 29 for the treatment of type 2 diabetes, which is the 4th sodium-glucose co-transporter-2 (SGLT2) inhibitor approved for marketing in China.

9. Ascletis’ marketing application for ravidasvir, a Class 1 new drug, was approved on July 29 for the treatment of chronic hepatitis C. Ravidasvir is the 2nd innovative drug developed by Ascletis for hepatitis C and is a next-generation NS5A inhibitor.

10. Nanjing Chia Tai Tianqing’s marketing application for Rivaroxaban Tablets, a Class 4 generic drug, was approved on July 29, which was deemed as passing the generic drug consistency evaluation in China. Before this, Rivaroxaban Tablets of Chiatai Tianqing, CSPC Ouyi, and Yangtze River Pharmaceutical have all been deemed as passing the generic drug consistency evaluation in China, and Nanjing Chia Tai Tianqing is the 4th in passing the generic drug consistency evaluation of the variety.

11. Hansoh Pharmaceutical’s marketing application for Empagliflozin Tablets, a Class 4 generic drug, was approved on July 29, making it the first generic of the variety in China.

12. AstraZeneca announced on July 30 that Esomeprazole Sodium for Injection (trade name: Nexium) was officially approved by the NMPA for the prevention of stress ulcer bleeding in critical patients.

FDA

13. Karyopharm, a partner of Antengene, announced on July 27 that the marketing application for the new indication of its selinexor, a selective inhibitor of nuclear export, for the treatment of patients with multiple myeloma after at least one prior line of therapy was officially accepted by the FDA, with the approval deadline expected to be the end of 2021 Q1.

14. MSD announced on July 30 that the FDA granted Breakthrough Therapy Designation to its MK-6482, a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of patients with VHL disease-associated renal cell carcinoma. The FDA also granted orphan drug designation to MK-6482 for VHL disease.

15. BMS and blue birdbio announced on July 30 that they submitted a BLA to the FDA for ide-cel, a CAR T-cell therapy jointly developed by them. The drug is a chimeric antigen receptor (CAR) T-cell therapy that targets B-cell maturation antigen (BCMA) for the treatment of adult patients with relapsed/refractory multiple myeloma.

16. AstraZeneca announced on July 30 that the FDA granted Breakthrough Therapy Designation to its osimertinib (trade name: Tagrisso) for the adjuvant treatment of patients with early-stage (IB, II and IIIA) EGFR-mutated non-small cell lung cancer (NSCLC)

EMA

17. Henlius announced on July 29 that HLX02 (trastuzumab for injection, Zercepac) applied for by its partner Accord was approved for marketing in the EU for the treatment of HER2-positive breast cancer and untreated HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.

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Pharmaceutical News of the Week | CPhI.CN - R&D

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