Top news story of the day:
Xuanzhu Biopharmaceutical files IPO application with the STAR Market
Xuanzhu Biopharmaceutical, Sihuan Pharm’s holding company, has filed for an IPO with the STAR Market to raise RMB 2.47 billion ($345.22 million). In December 2021, the company completed its latest round of financing worth RMB 610 million, ultimately valuing the company at RMB 6.91 billion.
Xuanzhu R&D pipeline covers digestive diseases, oncology and NASH. Its new large molecule drugs include HER2 dual antibodies and HER2 bispecific ADCs. The company currently has one product under NDA review, two products in Phase III clinical studies, one product under ANDA review, and more than a dozen drug candidates in preclinical development.
KBP-3571, which is under NDA review, is a PPI inhibitor with an indication for duodenal ulcers. It will also be expanded for the indication of reflux esophagitis in adults, with Phase II clinical trials about to begin.
Clinical studies of the CDK4/6 inhibitor XZP-3287 in combination with fulvestrant and an aromatase inhibitor for the treatment of breast cancer have entered Phase III. XZP-3621, its ALK inhibitor product for ALK-positive advanced NSCLC, has also entered clinical Phase III.
In other news:
SingMed has completed a Series A round to fund the company's drug delivery technology platforms for pulmonary and nasal delivery. The company specializes in complex drug delivery devices.
The CDE accepted an IND application from Gluetacs Therapeutics for its molecular glue degrader. The company’s former shareholder, Grains Valley Venture Capital, completed a capital increase for the company.
Autoimmune disease specialist LongBio Pharma has closed a Series A+2 financing round.
Hansoh Pharma announced a strategic partnership with KiOmed Pharma for the development, registration and commercialization of KiOmedine One, a new-generation osteoarthritis innovative drug, in China.
BIOHENG announced that its universal CAR-T product, RD13-01, has demonstrated a good safety and efficacy profile with an ORR of approximately 82% in a Phase I clinical study. The drug is in trials for the treatment of T-lineage hematologic tumors.
Brii Biosciences announced top-line results from a Phase I study evaluating its long-acting, single-injection therapy, BRII-296, for the treatment of PPD. The data show that a single intramuscular injection of 600 mg achieved dose linearity, early drug absorption and gradual and extended release profiles without the need for dose titration or tapering.
By Sarina Yang