The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
Astrazeneca plc has added a dual PDE3/4 inhibitor candidate to its chronic obstructive pulmonary disease (COPD) portfolio via a deal worth up to $2.1 billion with Chia Tai Tianqing Pharmaceutical Group Co. Ltd., a Sino Biopharmaceutical Ltd. subsidiary.
Neuracle Medical Technology Co. Ltd. is seeking a Shanghai IPO that could make it China’s first publicly listed invasive brain-computer interface (BCI) company, months after winning approval for the country’s first invasive BCI system.
Opus Genetics Inc. has secured U.S. FDA alignment on an eight-patient phase III trial of its lead gene therapy, OPGx-LCA5, for an ultra-rare form of inherited childhood blindness.
Alebund Pharmaceuticals (Jiangsu) Ltd. was the third Chinese biotech company to debut in Hong Kong this month, with June IPO proceeds from Alebund, Longbio Pharma Co. Ltd. and Shaanxi Micot Pharmaceutical Technology Co. Ltd. totaling about HK$4.7 billion (US$600 million).
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.
Neuracle Medical Technology Co. Ltd. is seeking a Shanghai IPO that could make it China’s first publicly listed invasive brain-computer interface (BCI) company, months after winning approval for the country’s first invasive BCI system.
Alebund Pharmaceuticals (Jiangsu) Ltd. was the third Chinese biotech company to debut in Hong Kong this month, with June IPO proceeds from Alebund, Longbio Pharma Co. Ltd. and Shaanxi Micot Pharmaceutical Technology Co. Ltd. totaling about HK$4.7 billion (US$600 million).
Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8.
Nuvectis Pharma Inc.’s shares climbed further after the oncology-focused biotech nabbed select rights to a late-stage complement factor B inhibitor (HSK-39297/NXP-100) and a phase I BRAF inhibitor (HSK-42360/NXP-200) from Haisco Pharmaceutical Group Co. Ltd. for $40 million up front.
