Pharmaceutical News of the Week （June.15th-19th）| PharmaSources.com

With the third week of June coming to a close, 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 15-19, including 30 pieces.

Approval

NMPA

1. The marketing application filed by Shanghai Zerun Biotechnology, a controlled subsidiary of Walvax Biotechnology, for the Recombinant Human Papillomavirus Bivalent (Type 16/18) Vaccine (Yeast) (Bivalent HPV Vaccine) was accepted by the NMPA on June 15, which will be used to prevent cervical cancer due to the infection by HPV 16 and 18

2. The marketing application (acceptance No.: JXSS1900044) of MSD’s anti-PD-1 monoclonal antibody: Keytruda changed to “Under approval” on June 15, which is likely to be approved this month. The indication applied for this time is the second-line treatment of patients with esophageal squamous cell carcinoma (ESCC), and if approved, it will be the 5th indication of Keytruda approved in China.

3. The Recombinant Human Insulin Injection of HEC Pharm, a subsidiary of HEC, was approved by the NMPA for marketing on June 15, which is the first biological product of HEC Pharm approved for marketing.

4. Sanofi’s marketing application (acceptance No.: JXSS1900067) for Dupilumab Injection in China changed to “Under approval” on June 16 and is expected to be officially approved in China soon. It will be used to treat moderate-to-severe atopic dermatitis. The drug is a monoclonal antibody directed against IL-4R co-developed by Sanofi and Regeneron.

5. Chiatai Tianqing’s marketing application for adalimumab injection was accepted by the CDE on June 16, making it the 6th pharmaceutical enterprise applying for the marketing of Humira biosimilar in China; wherein, the applications of Biothera and Hisun Pharmaceutical were separately approved in Nov. 2019 and Dec. 2019.

6. Zhejiang Hacon’s marketing application for Parecoxib Sodium for Injection according to the new Class 4 was approved by the NMPA on June 17, which was deemed as passing the consistency evaluation, making the company the second in passing the consistency evaluation of the product in China following Baiyu Pharmaceutical.

7. Sinqi Pharmaceutical’s Class 3 generic drug: Cyclosporine Eye Drops (II) was approved by the NMPA for marketing on June 17 to treat dry eye. The original drug was developed by Allergan and approved by the FDA for marketing in Dec. 2002, with the trade name: Restasis (0.05%, emulsion), however, it has not been approved in China.

8. Hengrui Medicine filed the marketing application for the Class 1 new drug: Hetrombopag Ethanolamine Tablets on June 18, which was accepted by the CDE on the same day. The drug will be mainly used to treat chronic primary immune thrombocytopenia (ITP) refractory to corticosteroids, immunoglobulins, or splenectomy. Hetrombopag is a highly selective TPO-R agonist with independent intellectual property rights, which is obtained after a series of modifications conducted by Hengrui to the structure of eltrombopag.

9. Kyowa Hakko Kirin’s Darbepoetin Alfa Injection was approved for marketing in China on June 19 to treat anemia in patients with chronic renal failure receiving hemodialysis. Dominating the international EPO market, darbepoetin alfa was co-developed by Amgen and Kyowa Hakko Kirin and approved by the FDA for marketing in Sep. 2001.

10. CSPC’s Class 4 generic drug: Bortezomib for Injection was approved by the NMPA for marketing on June 19, which was deemed as passing the consistency evaluation. As a new proteasome competitive inhibitor, bortezomib is clinically mainly used for multiple myeloma and mantle cell lymphoma. The drug was approved by the FDA in May 2003 and approved in China in Jan. 2005, with the trade name: VELCADE.

11. Innovent Biologics’ bevacizumab injection was approved for marketing on June 19, making the company the 2nd in receiving the approval for this biosimilar in China following Qilu Pharmaceutical.

12. Sunshine Guojian’s inetetamab was approved by the NMPA for marketing on June 19 to treat HER2-positive metastatic breast cancer. As the first HER2 drug filed the NDA in China, inetetamab is expected to take the lead in breaking the monopoly of foreign pharmaceutical enterprises in this area of China.

13. The applications for 2 new indications of Hengrui’s camrelizumab were officially approved by the NMPA for marketing on June 19, separately being the second-line treatment of advanced esophageal squamous cell carcinoma as monotherapy and first-line treatment of advanced or metastatic non-squamous non-small cell lung cancer in combination with pemetrexed and carboplatin.

14. Hansoh Pharmaceutical’s 2 new drugs for central nervous system diseases were approved on June 19, separately Paliperidone Extended-Release Tablets and Olanzapine Orally Disintegrating Tablets. The 2 new drugs were applied for according to the new Class 4 and deemed as passing the consistency evaluation after the approval. Wherein, Paliperidone Extended-Release Tablets is the first generic marketed in China.

FDA

15. On June 15, the FDA revoked the Emergency Use Authorization (EUA) of chloroquine/hydroxychloroquine to treat COVID-19. According to the latest clinical results, chloroquine/hydroxychloroquine is unlikely to be effective in treating COVID-19. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the potential benefits of chloroquine/hydroxychloroquine no longer outweigh the known and potential risks thereof.

16. On June 15, the FDA approved the marketing of the first game-based digital therapy: EndeavorRx (AKL-T01) in children aged 8-12 with attention-deficit/hyperactivity disorder (ADHD), which requires the doctor’s prescription.

17. Jazz Pharmaceuticals/PharmaMar announced on June 15 that the marketing of Zepzelca was approved by the FDA through accelerated approval to treat metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Luye Pharma entered into a license agreement with PharmaMar in Apr. 2019 for the exclusive development and commercialization of lurbinectedin (including all indications such as SCLC) in China, which was in phase 3 clinical trial back then.

18. The ANDA for Hengrui Medicine’s Dexmedetomidine Hydrochloride Injection was approved on June 17 (specifications: 80ug/20mL, 200ug/50mL, and 400ug/100mL), which means that Hengrui can produce and market the product in the U.S. market.

R&D

19. On June 15 during the 80th Scientific Sessions of the American Diabetes Association (ADA), Novo Nordisk released the phase 2 clinical trial results of the once-weekly basal insulin analogue: insulin icodec in development, according to which, the drug was similar to once-daily insulin glargine U100 in terms of blood sugar control and safety profile in adult patients with type 2 diabetes.

20. A Phase III clinical trial of a recombinant mutant human tumor necrosis factor-related apoptosis-inducing ligand (CPT) for the treatment of patients with relapsed or refractory multiple myeloma was successful on June 15. The said CPT is independently developed by Sunbio Biotech, a company in which Hiteck Biological has a stake. In the trial, the trial group showed significant benefits, and the analysis of most subgroups also showed benefits consistent with the full analysis set.

21. MSD/Pfizer released the data of Phase III VERTIS CV clinical trial at ADA 2020 sessions on June 16, according to which, their SGLT2 inhibitor: Steglatro was non-inferior to placebo on major adverse cardiovascular events (MACE) in patients with type 2 diabetes and atherosclerotic cardiovascular disease and met the primary endpoint.

22. Eli Lilly announced on June 16 that results from a pre-planned interim analysis of Phase 3 monarchE study met the primary endpoint; Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) could significantly improve invasive disease-free survival (IDFS) in patients, significantly decreasing the risk of recurrence or death compared to standard adjuvant ET alone.

23. Ascentage Pharma announced on June 17 that the Phase II clinical study of its Class 1 new drug: IAP inhibitor APG-1387 in combination with entecavir for the treatment of patients with chronic hepatitis B (CHB) dosed its first patient in China.

24. Roche announced on June 18 that the Phase III IMpassion031 study evaluating Tecentriq in combination with chemotherapy met its primary endpoint of pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression.

Policies

25. According to enterprise applications, Shandong Public Resources Trading Center announced the Information on Some Pharmaceutical Products Applied for Removal from the Internet Procurement (Third Batch in 2020) on June 17, involving a total of 44 pharmaceutical products, including well-known pharmaceutical products such as Hansoh Pharmaceutical’s repaglinide tablets and canagliflozin tablets, and Zai Lab’s niraparib tosylate capsules.

26. Hubei Province Drug Price and Tender Procurement Management Service Website released the Notice on Doing a Good Job in the Centralized Procurement and Use of the Second Batch of Drugs Organized by the State on June 17, requiring various related medical institutions of Hubei Province to comprehensively initiate the centralized procurement with target quantity and use of the second batch of 32 pharmaceutical products selected in China from June 20.

Transactions

27. JS InnoPharm (Shanghai) Ltd. (“JSI”) announced on June 15 that it completed its Series A+ funding of nearly RMB100 million led by Ming Bioventures and co-invested by Efung Capital, SIDVC, Zhidao Capital, and Oriental Fortune Capital. This series will be mainly used to promote the Phase I clinical trial of JSI’s ERK inhibitor: JSI-1187 and establish an R&D pipeline with new oncology drugs as the core.

28. Takeda and Neurocrine Biosciences announced a strategic collaboration on June 16 to develop and commercialize the early-to-mid-stage new drug programs in development in Takeda’s psychiatry pipeline. Specifically, Takeda granted an exclusive license to Neurocrine Biosciences for 7 pipeline programs, including 3 clinical stage assets for schizophrenia, treatment-resistant depression and anhedonia.

Listing

HKEX

29. On the evening of June 16, Biothera announced that the Proposal on the Company Issuing H Shares and Listing on the Stock Exchange of Hong Kong, S.A.R., China was deliberated and passed at the 16th Meeting of its First Board of Directors, which was Biothera’s another seeking of listing and financing following its listing on the STAR Market on Feb. 21, 2020, with an interval of only 117 days.

SZSE

30. Chengdu Kanghua Biological Products Co., Ltd. was officially listed on the SZSE ChiNext market on June 16, with not more than 15 million shares issued at RMB70.37/share and the funds to raise of RMB1.055 billion. Its open price was RMB84.44 and its close price reached RMB101.33 (+44.00%) on that day, with a total market capitalization of RMB6.080 billion.

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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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