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 treating unresectable locally advanced esophageal squamous cell carcinoma with camrelizumab in combination with concurrent radiochemotherapy vs. placebo.

14. On June 1, Chiatai Tianqing registered and launched a randomized, positive drug parallel controlled, multicenter phase III clinical trial of first-line treatment of triple-negative breast cancer with TQB2450 in combination with anlotinib vs. paclitaxel for injection. As an anti-PD-L1 monoclonal antibody developed by Chiatai Tianqing, TQB2450 is intended to treat melanoma, primary mediastinal large B-cell lymphoma, and advanced soft tissue sarcoma, etc.

15. Innovent Biologics and its partner Eli Lilly announced on June 1 that they released multiple clinical data of sintilimab at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO 2020).

16. The clinical trial of Chipscreen Biosciences’ Class 1 new drug CS12192 capsules was approved on June 4 to treat rheumatoid arthritis. As a highly selective JAK3 inhibitor, CS12192 will be used to partially inhibit JAK1 and TBK1. There is no inhibitor drug of this class marketed.

17. FibroGen filed a new drug clinical trial application for Pamrevlumab in China on June 4, which was accepted. As a first-in-class new drug developed by FibroGen, Pamrevlumab can inhibit the activity of connective tissue growth factor (CTGF) and is now in phase III clinical trial of treating idiopathic pulmonary fibrosis (IPF) and locally advanced pancreatic cancer (LAPC) and phase II clinical trial of treating Duchenne muscular dystrophy (DMD).

Policies

18. The Law of the People’s Republic of China on the Promotion of Basic Medical and Health Care has come into force on June 1, which stipulates issues including the supply of pharmaceutical products, review and approval system, emergency reserves for major epidemics and emergencies, pharmaceutical product information traceability, and TCM characteristic development, etc. in the part of guarantee for supply of pharmaceutical products. Violations in pharmaceutical product procurement bidding may be subject to severe penalties according to this law.

Transactions

19. AbbVie and Jacobio Pharmaceuticals announced on June 1 that they reached a global strategic collaboration to jointly develop and commercialize SHP2 inhibitors which target a key node in cancer and immune cells. Under the terms of the agreement, AbbVie will be granted an exclusive license to the SHP2 portfolio.

20. AstraZeneca announced on June 4 that it would cooperate with Accent Therapeutics to develop and commercialize transformative therapeutics targeting RNA-modifying proteins (RMPs). Accent will obtain an upfront payment of USD55 million in this transaction, and the cooperation will focus on RMP inhibitor.

Marketing

STAR Market

21. During June 1-4, the listing of 4 pharmaceutical enterprises on the STAR Market was accepted, separately, Jiangsu Carephar Pharmaceutical, Shanghai ZJ Bio-Tech, Shanxi Jinbo Bio-Pharmaceutical, and Assuro Tech. (Hangzhou); 2 were inquired, separately HOB Biotech, and Liaoning Chengda Biotechnology; 3 were passed at the meeting of the Listing Committee, separately Guangzhou LBP Medicine, Beijing Succeeder Technology, and Jiangsu Aidiea Pharmaceutical; wherein, Aidiea Pharmaceutical has filed the registration application on June 4.

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

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