With the second 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 8-12.

Approval

NMPA

1. Boehringer Ingelheim announced on June 8 that Nintedanib Esilate Soft Capsules (trade name: Ofev) has been approved by the NMPA for marketing, making it the first and currently the only drug for systemic sclerosis-associated interstitial lung disease (SSc-ILD) in China, which is the 2^nd indication of the drug approved in China.

2. Yiling Pharmaceutical announced on June 8 that its marketing application for Yizhi Anshen Tablets has been accepted by the CDE, which is a new Chinese medicine developed according to the theoretical guidance of Chinese Eight-word Health Preservation for the pathogenesis and therapy of insomnia.

3. Roche’s clinical trial application for tiragolumab injection in China was accepted by the CDE on June 8. Tiragolumab is an anti-TIGIT monoclonal antibody. The preliminary clinical results have shown certain safety and anti-tumor effectiveness of anti-TIGIT antibody either as monotherapy or in combination with anti-PD-1/PD-L1 antibody, and especially the combination therapies hopefully exhibited synergistic enhancement effect. To date, there is no variety in its class approved in the world.

4. The clinical trial of MSD’s letermovir injection/tablets has been approved in China on June 8, which is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). The drug has been approved by the FDA for marketing in Nov. 2017, with the trade name: Prevymis, being the first drug approved to treat CMV in the U.S. in recent 15 years.

5. Hansoh’s marketing application for Class 4 generic drug Paliperidone Extended-Release Tablets (acceptance No.: CYHS1900200, CYHS1900201) has changed to “Under approval” on June 9, which is expected to be approved for marketing soon. Developed by J & J, the original drug of Paliperidone Extended-Release Tablets belongs to the second-generation antipsychotic drugs and was approved by the FDA for marketing in Dec. 2006 and by the NMPA for marketing in 2008. There is only the imported original drug in China. Hansoh will market the first generic.

6. According to the NMPA website on June 10, the marketing application for the contrast agent Iohexol Injection newly introduced by Hengrui in May has changed to the “Under approval” status and will be approved soon, while another contrast agent Iopamidol Injection introduced thereby simultaneously has been approved for marketing 1 month ago.

7. Roche’s marketing application for its new anti-influenza drug Baloxavir Marboxil Tablets (trade name: Xofluza) in China has been accepted by the CDE on June 10. Developed by the Japanese pharmaceutical enterprise Shionogi, Roche reached a cooperation agreement therewith in 2016 to be responsible for the R&D of the drug outside Japan and Taiwan, China Region of China, and have the right to commercially promote it outside Japan and Taiwan, China Region of China.

8. Takeda applied for the marketing of Icatibant Acetate Injection in China on June 11, which will be used to treat the acute attacks of hereditary angioedema (HAE) in adults, which is a rare hereditary disease. Icatibant is a selective bradykinin B2 receptor antagonist developed by Shire, which can inhibit the effects of bradykinin associated with HAE symptoms. The drug was approved by the FDA for marketing in Aug. 2011.

9. According to the CDE website on June 11, the new drug AMG160 jointly applied for by Amgen and BeiGene has been approved for the clinical trial to treat metastatic castration-resistant prostate cancer (CRPC) in adults. As a new HLE-BiTE immunotherapy, AMG160 can make T cells directionally kill tumor cells by binding to PSMA on tumor cells and CD3 on T cells, while PSMA is a tumor-related antigen overexpressed on the surface of metastatic and hormone-refractory prostate cancer cells.

FDA

10. Insmed announced on June 8 that the FDA has granted breakthrough therapy designation for brensocatib (INS1007) for the treatment of adult patients with non-cystic fibrosis bronchiectasis (NCFBE) for reducing lung exacerbations of patients.

11. BMS announced on June 10 that the FDA has approved a new indication of its Opdivo for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. It is the first approved immunotherapy in this patient population regardless of tumor PD-L1 expression level.

R&D

12. A clinical trial has been initiated for Innovent Biologics’ Class 1 new drug IBI362 for injection on June 9 in overweight or obese subjects. IBI362 (code: OXM3) is a dual agonist of glucagon-like peptide-1 (GLP-1) and glucagon receptor developed by Eli Lilly. Innovent and Eli Lilly reached strategic cooperation in Aug. 2019 to jointly advance the development and commercialization of OXM3 in China.

13. MSD announced on June 9 that the Phase 3 KEYNOTE-361 trial evaluating Keytruda in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic urothelial carcinoma (bladder cancer) did not meet its pre-specified dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy.

14. On June 10, AbbVie announced positive data from a Phase 2a proof-of-concept study of ABBV-3373, an ADC, in adult patients with moderate to severe rheumatoid arthritis (RA). These were the first clinical data disclosed for the ADC in RA indication.

Policies

15. The National Health Commission of the People’s Republic of China issued the Announcement on Soliciting Public Opinions on the Notice on Doing a Good Job in the Administration of the Clinical Application of Antimicrobial Drugs under the New Situation (Draft for Comment) on June 9.

Transactions

16. Innovent Biologics announced on June 9 that it entered into a strategic collaboration with Roche. Under the terms of the agreement, Innovent will pay upfront, development and commercial milestone payments, and royalties, to non-exclusively access certain Roche technologies that enable the discovery and development of specific 2:1 T-cell bispecific antibodies (TCB) and the universal CAR-T platform.

17. Hengrui announced on June 9 that the company and Japan Oncolys agreed to terminate the cooperation relating to the oncolytic virus product Telomelysin^TM (OBP-301) upon consultation and they signed a termination agreement. Hengrui reached an agreement in Dec. 2016 with Oncolys to pay to secure the exclusive license to develop, produce, and commercialize the said Telomelysin (OBP-301) in the Chinese mainland, Hong Kong, S.A.R., China, and Macau, S.A.R., China.

18. AbbVie and Genmab announced on June 10 that both parties have entered into a broad collaboration agreement to jointly develop and commercialize Genmab’s next-generation bispecific antibody drugs, epcoritamab (DuoBody?-CD3xCD20), DuoHexaBody?-CD37 and DuoBody-CD3x5T4, at early stages. Both parties have also reached early drug discovery cooperation in developing differentiated therapies for tumors, mainly involving 4 next-generation antibody drugs that target solid tumors and hematological malignancies.

Listing

STAR Market

19. According to the disclosure on the website of the STAR Market of Shanghai Stock Exchange on June 10, Chengdu Easton Biopharmaceuticals Co., Ltd. has passed the second submission and planned to finance for RMB1.161 billion on the STAR Market. The first submission of Easton Biopharmaceuticals took place in Apr. 2019 and was terminated in Aug. 2019.

HKEX

20. Simcere Pharmaceutical applied for listing on the Main Board of the Hong Kong, S.A.R., China Exchanges and Clearing Market (HKEX) on June 10, with Morgan Stanley and China International Capital Corporation Limited as its joint sponsors. Simcere Pharmaceutical has been successfully listed in the U.S. on Apr. 20, 2007 to raise USD226 million with a market capitalization exceeding USD1 billion, and it became the first Chinese biological and chemical-pharmaceutical company listed on the New York Stock Exchange.

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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