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 oral, potent, and highly selective  small-molecule inhibitor of PD-L1, ASC61 blocks the PD-1/PD-L1 interaction by inducing PD-L1 dimer formation and endocytosis. 

10. On January 11, Hengrui Medicine declared that the U.S. FDA agreed to conduct a Phase III clinical trial of Herombopag Olamine Tablets for chemotherapy-induced thrombocytopenia in the near future. Herombopag Olamine is an oral non-peptide thrombopoietin receptor (TPO-R) agonist with NMPA approval for use in June 2021. 

11. On January 10, CARsgen made an announcement that its self-developed CAR-T product CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) status by the U.S. FDA with respect to the treatment of Claudin18.2 (CLDN18.2) positive advanced gastric cancer/adenocarcinoma of the esophagogastric junction (GC/GEJ). 

Related transaction 

12. On January 10, Junshi Biosciences announced an expanded collaboration with Coherus in the field of oncology immunology. Coherus has initiated the process to exercise the license option for JS006 in the U.S. and Canada. Coherus would make a US$35 million down payment to Junshi Biosciences, up to US$255 million in development, filing and sales milestone payments, as well as an 18% sales share of net product sales. JS006 is a recombinant humanized IgG4κ monoclonal antibody specifically against human TIGIT, which was researched and developed by Junshi Biosciences. 

R&D 

13. On January 11, Fosun Pharma and Insilicon Medicine jointly announced a cooperation agreement for advancing AI drug R&D in multiple targets globally. This strategic collaboration includes an AI-driven drug R&D collaboration for four specified targets and a co-development collaboration for the Insilicon Medicine QPCTL program. 

14. On January 12, Harbour BioMed released the first interim analysis of the Phase III registration clinical trial of its investigational new drug, tanfanercept (HBM9036), in China. Tanfanercept (HBM9036) is an innovative global tumor necrosis factor (TNF) receptor-1 fragment-based drug for adult patients with DED. 

15. On January 13, Stone Pharma reported that the registrational clinical research (GEMSTONE-201) of Sugemalimab Injection for the treatment of relapsed or refractory extranodal natural killer cell/T-cell lymphoma (R/R ENKTL) reached its primary study endpoint. Stone Pharma plans to file a new drug application to the NMPA for Sugemalimab in the R/R ENKTL indication in the near future. 

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.