Weekly Pharmaceutical News Review of PharmaSources.com (January 17th to 21st)

The news review in this week is from January 17 to 21, covering a total of 19 pieces of information in 4 sections, i.e. review, transaction, R&D, and listing. 

Review

NMPA 

Listing 

1. On January 17, Luye Pharma announced that CDE had accepted its listing application for Oxycodone Hydrochloride and Naloxone Hydrochloride Dehydrate Prolonged Release Tablets (LY021702). LY021702 is an analgesic under research developed by Luye Pharma. It is intended for the treatment of moderate and severe chronic pain that cannot be effectively controlled by non-opioid drugs. 

2. On January 18, the CDE official website revealed that the listing application of BeiGene's Zanubrutinib Capsules for new indications was accepted. The listing application registration is classified in Class 3, and the indication is to treat Waldenström macroglobulinemia (WM) of adults. In June 2021, Zanubrutinib has been approved in China for second-line treatment of WM. Upon the approval of this application, the range is expected to be expanded to first-line treatment. 

3. On January 19, the CDE official website revealed the acceptance of the listing application of Hengrui Medicine's PD-L1 monoclonal antibody adebrelimab. It is for the indication of the first-line treatment of extensive-stage small-cell lung cancer combined with chemotherapy. This is the fifth Chinese PD-L1 monoclonal antibody declared for listing. At present, Hengrui has launched 11 clinical trials for SHR-1316 in China, of which 3 indications have entered Phase III clinical trials. 

4. On January 19, the NMPA official website revealed that Class 1 new drug, ormutivimab, of North China Pharmaceutical, is in the stage of "under approval" and is expected to be approved for listing in the near future. It is used for the passive immunity of patients exposed to the rabies virus. At present, there is no recombinant anti-rabies virus monoclonal antibody on the Chinese market, and the only passive immunity preparations that can be used for rabies virus post-exposure prophylaxis in China are anti-rabies serum and immune globulin of rabies cases. 

5. On January 19, NMPA issued a new approval document, and adalimumab biosimilar of Chiatai Tianqing was approved for listing. It is the sixth adalimumab approved for marketing in China. The original adalimumab is a fully human anti-tumor necrosis factor alpha (TNF-α) monoclonal antibody developed by AbbVie for the treatment of immune diseases. The trade name is Humira. 

6. On January 20, NMPA issued the latest approval document. Class 3 generic drug, nimodipine oral solution, of Hengrui Medicine, was approved for listing, which is the first approved drug of this type in China. Nimodipine is targeted at high blood pressure, which can be grouped into 1,4-dihydropyridine calcium ion antagonists. It is also incorporated in the list of children drugs encouraged to be developed and declared. 

Clinic 

7. On January 17, the CDE official website announced that Roche had submitted a clinical trial application for RO7191863 injection in China, which has been accepted. According to public information, RO7191863 is a liver-directed, PD-L1-targeting N-acetylgalactosamine (GalNac)-modified single-stranded oligonucleotide candidate drug. It is planned to be developed for the treatment of chronic hepatitis B. 

8. On January 18, Henlius announced that NMPA has approved the clinical trial application (IND) of the innovative BRAFV600E small molecule inhibitor HLX208 introduced from NeuPharma. The application approved this time is a Phase 1b/2 clinical trial. It aims to evaluate the effect of HLX208 monotherapy or in combination in the treatment of BRAFV600E or BRAFV600 mutation-positive advanced solid tumors. 

9. On January 18, CDE announced that the bempegaldesleukin declared by NektarTherapeutics has been given the implied license for clinical trials, which is intended to be developed for the treatment of squamous cell carcinoma of the head and neck. According to public information, this is an agonist targeting the IL-2 signaling pathway, which has been granted a breakthrough therapy designation by the FDA. The R&D code is NKTR-214. 

10. On January 20, the CDE official website revealed that XPO1 inhibitor WJ01075 of Junjing Biosciences was approved for clinical use for the first time. As a kind of active pharma ingredients, it is applied for the treatment of advanced malignant tumors. This is the second XPO1 inhibitor of Junjing Biosciences that has entered into clinical development. In August 2021, the Phase I clinical trials of the first XPO1 inhibitor WJ01024 of the company have been launched. 

11. On January 20, the CDE website revealed that elranatamab of Pfizer received an implied license for clinical trials. It is intended for the following indications: monotherapy or in combination with Daratumumab for patients with multiple myeloma who have received at least first-line treatment of anti-multiple myeloma therapy (including lenalidomide and a proteasome inhibitor). elranatamab is a bispecific antibody drug targeting BCMA and CD3, which has entered Phase 3 clinical research globally.

FDA 

12. On January 17, Ascletis announced that the clinical trial application of subcutaneous injection of PD-L1 antibody envafolimab in the U.S. was approved, and it is for the treatment of chronic hepatitis B. Envafolimab is the fastest clinically immunotherapy in the world for the treatment of chronic hepatitis B by blocking the PD-1/PD-L1 pathway. In January 2019, Ascletis and Alphamab Oncology entered into cooperation for the first time and obtained the rights and interests of the drug in Greater China. 

13. On January 18, Huahai Pharmaceutical announced that the U.S. FDA has approved the clinical trial application for anti-PD-L1/TIGIT double-antibody HB0036 injection of its subsidiary, Huaota Biopharmaceutical Co., Ltd. According to public information, HB0036 was independently developed by Huaota Biopharmaceutical Co., Ltd. and it is a bispecific antibody targeting PD-L1 and TIGIT. 

Related transaction 

14. On January 17, Abbisko announced that it has reached global cooperation and exclusive license agreement with Eli Lilly to further focus on the undisclosed target in major diseases with unmet medical needs, such as cardiometabolic diseases. The cooperation is extended to the discovery, development, and potential commercialization of novel small molecule drugs. 

15. On January 18, AmagmaTherapeutics announced a strategic partnership with Innovent in the field of inflammatory diseases to develop three enzyme specificity inhibitors derived from Amagma's proprietary platform SEIZMIC. The agreement grants Innovent an exclusive option to develop and commercialize the above-mentioned products in Greater China, and Amagma retains all rights outside of China. 

R&D 

16. On January 18, AstraZeneca announced the data of Phase III clinical TOPAZ-1 study of PD-L1 monoclonal antibody durvalumab in combination with chemotherapy in the first-line treatment of advanced biliary tract cancer (BTC) at 2022ASCO GI. The primary endpoint of overall survival (OS) was met at the interim analysis. This is the first immunotherapy that has obtained positive results in a global Phase III clinical trial for first-line treatment of biliary tract cancer. 

17. On January 18, at the 2022 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI), MSD announced the results of Phase 3 clinical KEYNOTE-394 study of Keytruda as a second-line monotherapy for hepatocellular carcinoma that progressed after sorafenib treatment. The final results indicated that the pembrolizumab treatment group demonstrated a statistically significant and clinically meaningful improvement in OS of the primary endpoint. This is the first Phase 3 clinical trial of PD-1/L1 inhibitor monotherapy in the second-line treatment of liver cancer in the world. 

18. On January 19, ImmVira announced that the gradability test of the first two dose groups of the US Phase 1 clinical trial towards its intravenous injection of herpes oncolytic virus MVR-T3011IV has recently been successfully completed. Patients with pancreatic cancer, colon cancer, lung cancer, and advanced endometrial cancer were recruited in the study, and good safety and tolerance results were achieved. There was no dose-limiting toxicity (DLT) and treatment-related serious adverse events (SAEs). 

Listing 

19. On January 18, Mabwell was officially listed on the Star Market of Shanghai Stock Exchange. At present, Mabwell has 15 varieties under research and in different stages of R&D. The listing applications of 3 varieties have been submitted, 3 varieties are in the key registration clinical research stage, and 6 varieties are in the Phase I/II clinical research stage.