This week in review is the news from January 10-14, covering a total of 15 pieces of information in 3 sections, i.e. review, transaction, and R&D.
Review
NMPA
Listing
1. On January 10, the CDE official website revealed that CANbridge's maralixiba was declared to be listed for priority review for cholestatic pruritus in patients aged 1 year and above with Alagille syndrome. In April 2021, CANbridge acquired the exclusive license for maralixiba, which was developed by Mirum, in Greater China for an upfront payment of US$ 11 million + up to US$ 109 million in milestone payments + net sales-based double-digit tiered royalties.
2. On January 10, the CDE official website revealed that Eli Lilly had declared the new indication of baricitinib for listing. Baricitinib Tablet is a JAK1/2 inhibitor indicated for adult patients with moderately to severely active rheumatoid arthritis, and such patients are not effective or intolerant to one or more DMARDs. It can be administered in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs.
3. On January 11, the listing application of Norolanib Tablets, a Class 1 new drug from Betta Pharmaceuticals, was accepted. The indication is the second-line treatment of advanced kidney cancer in combination with everolimus. Norolanib is a new multi-target kinase inhibitor with a new chemical structure, which curbs tumor angiogenesis and growth for the treatment of various cancers.
4. On January 11, the latest NMPA approval demonstrated that the Class 2.2 new drug Mitoxantrone Hydrochloride Liposome Injection of CSPC was approved for listing. It is for relapsed or refractory peripheral T-cell lymphoma (PTCL) patients who have undergone at least first-line standard treatment in the past. For now, no similar products have been available worldwide and Chinese listed products are Mitoxantrone Injection.
5. On January 11, the latest approval of NMPA showed that Kyowa Kirin's Romiplostim for Injection was approved for listing in primary immune thrombocytopenia (ITP). Romiplostim is a second-generation oral TPO-R agonist drug, which has been approved by FDA and EMA for the second-line treatment of immune thrombocytopenic purpura. It is characterized by rapid onset of action, low dosing frequency, and a better safety profile.
6. On January 11, the CDE official website revealed that the listing application of Zuberitamab from Hisun was accepted, being the first CD20 monoclonal new drug declared for listing in China. Zuberitamab is a new differential human-mouse chimeric anti-CD20 monoclonal antibody. In October 2007, Hisun obtained the human-mouse chimeric anti-CD20 monoclonal antibody from Mabworks for the preclinical project.
Below is some information about clinic and FDA, if you want to explore more information about them, access to Pharmasource, a vertical e-commerce online platform serving the pharmaceutical industry, providing information on high-quality products and medical product suppliers for global customers and delivering services.
Clinic
7. On January 10, the CDE official website revealed that Bailisikang Biological Pharmaceutical submitted an application for the clinical trial of Class 1 new drug BB-1705 for injection and was accepted. BB-1705 is an ADC drug targeting EGFR, which incorporates eribulin as a toxicity agent. Eribulin is an approved anti-tumor small molecule drug introduced from Eisai.
8. On January 12, the CDE official website revealed that the investigational new drug SCR-6920 of Simcere Pharmaceutical Group Limited was accepted for submission of a clinical trial application for the treatment of advanced malignancies. SCR-6920 is a synthetic lethal antitumor innovative mechanism oral protein arginine methyltransferase enzyme 5 (PRMT5) inhibitor.
FDA
9. On January 10, Ascletis announced that it has filed an IND for ASC61 in the U.S. for the treatment of advanced solid tumors. As an ...
(All Rights Reserved)