With the first week of June coming to a close, let’s review the hot events of the pharmaceutical industry this week. The news involved approval, R&D, policies, transactions, and marketing that happened during June 1-5, including 21 pieces.
Approval
1. The marketing application of Huazhong Pharmaceutical for Ambroxol Hydrochloride Injection according to the new Class 4 was approved by the NMPA on June 1, which was deemed as passing the consistency evaluation, making the company the second in passing the consistency evaluation of Ambroxol Hydrochloride Injection in China.
2. The 2 generic drugs: Oxaliplatin Injection and Entecavir Tablets of Qilu Pharmaceutical were approved for marketing and deemed as passing the consistency evaluation on June 1; wherein, the marketing approval of Class 3 generic drug Oxaliplatin Injection made the company the first in passing the consistency evaluation of the pharmaceutical product in China.
3. The marketing applications of Hengrui Medicine and Yangtze River Pharmaceutical for Gefitinib Tablets were separately approved by the NMPA on June 1. They were both applied for marketing according to Class 4 and deemed as passing the consistency evaluation. With this, the number of enterprises passing the consistency evaluation for this variety in China increased to 5.
4. The marketing application of Hangzhou Minsheng Binjiang Pharmaceutical for Alendronate Sodium Tablets according to the new Class 4 was approved by the NMPA on June 1, which was deemed as passing the consistency evaluation, making the company the first in passing the consistency evaluation of Alendronate Sodium Tablets in China.
5. HEC announced on June 1 that its Olanzapine Orally Disintegrating Tablets was approved by the NMPA and deemed as passing the consistency evaluation, making the company the third in passing the consistency evaluation for the dosage form of the variety in China.
6. Hansoh filed the marketing application for Class 4 generic drug Enzalutamide Soft Capsules on June 2, which has been accepted, making the company the first with the marketing application acceptance of such variety in China. Enzalutamide is the first oral drug approved by the FDA for metastatic and non-metastatic castration-resistant prostate cancer.
7. According to the CDE’s website on June 2, the marketing application filed by Nanjing Yoko for Butylphthalide Injection according to the registration class 2.2 was accepted by the CDE, which will be used to improve the neurologic impairment of patients with acute ischemic stroke.
8. The marketing of Genzyme’s Laronidase Injection, Solution, Concentrate (trade name: Aldurazyme) was approved by the NMPA on June 3 through the priority review and approval procedure, which will be used for long-term enzyme replacement therapy in patients with Mucopolysaccharidosis I to treat the non-neurological manifestations of the disease.
9. Two indications of BeiGene’s Class 1 new drug zanubrutinib were approved in China on June 3, making it the first-approved Chinese-produced BTK inhibitor, with the indications approved being: relapsed/refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
10. The marketing application of Nanjing Chiatai Tianqing for Aprepitant Capsules according to Class 4 generic drugs was approved on June 3, which will be deemed as passing the consistency evaluation after being approved for production. Developed by MSD, aprepitant was approved for import in 2013 to inhibit tumor chemotherapy-induced nausea and vomiting.
11. Hansoh Pharmaceutical filed the marketing application for Carfilzomib for Injection according to Class 3 on June 3, which will be mainly used to treat multiple myeloma.
FDA
12. Eli Lilly announced on June 1 that the FDA approved Cyramza (ramucirumab), in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. With this approval, Cyramza has received 6 FDA approvals to treat certain types of lung, liver and stomach cancers.
R&D
13. Hengrui announced on June 1 that the NMPA approved the conduct of the randomized, double-blinded, controlled multicenter phase III clinical study (SHR-1210-III-323) of...
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