Minghui Gene Submits IPO Prospectus Following Clinical Approval of Anti-CD30 CAR-T Therapy

Jul 12, 2024 07:31 CST Updated 07:31

Simcere

Innovative Drug Developer

On July 10, the CDE website announced that the investigational new drug application for an anti-CD30 chimeric antigen receptor autologous T-cell injection, submitted by Minghui (Nanjing) Gene Biotechnology Co., Ltd., has been approved for clinical trials. The drug is intended for development in treating CD30-positive tumors such as Hodgkin lymphoma and anaplastic large cell lymphoma.

On July 11, Immorna (Hangzhou) Biotechnology Co., Ltd. announced that the U.S. FDA has approved the Phase II clinical trial of its self-developed self-replicating RNA (srRNA) herpes zoster vaccine JCXH-105, and subject enrollment is about to begin.

On July 11, Simcere (2096.HK) announced: The National Medical Products Administration has approved the transition of Xianorin® (Xianotrelvir Tablets/Ritonavir Tablets Combination Packaging) from conditional approval to full approval for the treatment of adult patients with mild to moderate Coronavirus Disease 2019 (COVID-19). Xianorin® has become the first orally administered anti-coronavirus drug in China to receive full approval.

On July 10, the CDE website announced that the 1.2 class new drug, Respiratory Syncytial Virus mRNA Vaccine, submitted by CSPC Jushi Biologics, received clinical implied permission for the prevention of lower respiratory tract diseases caused by Respiratory Syncytial Virus infection.

Investment and Financing Pharmaceutical Affairs

On July 10, Baili Tianhe submitted an IPO application to the Hong Kong Stock Exchange, with Goldman Sachs, J.P.Morgan, and CITIC Securities as joint sponsors. In December 2023, Baili Tianhe announced an exclusive licensing and cooperation agreement with Bristol-Myers Squibb for the EGFR/HER3 bispecific antibody-drug conjugate (bispecific ADC) BL-B01D1, with a total potential value of up to $8.4 billion. Earlier in 2023, the company had already gone public on the Shanghai Stock Exchange's STAR Market.

Technology-Driven Drug Research

On July 10, the research team led by Professor Yin Mingzhu from Chongqing University/Chongqing University Affiliated Three Gorges Hospital published a research paper titled "Tumour vasculature at single-cell resolution" in the prestigious international academic journal Nature. This study constructed the largest-scale pan-cancer vascular system holographic cell atlas to date, covering approximately 200,000 cells from 372 donors, representing 31 cancer types. The research provides a panoramic perspective for fully understanding the complex process of tumor angiogenesis and offers scientific solutions for clinically enhancing the efficacy of anti-angiogenic therapies.

[1]Pan, X., Li, X., Dong, L. et al. Tumour vasculature at single-cell resolution. Nature (2024). https://doi.org/10.1038/s41586-024-07698-1

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