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 breakthr...
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