Remegen Co. Ltd.’s telitacicept (RC-18) met the primary endpoint in a phase III trial for treating primary Sjögren's syndrome (pSS), and the company plans to submit a BLA to China’s National Medical Products Administration (NMPA) on the data.
Minghui Pharmaceutical Ltd. announced it is raising $131 million in a pre-IPO financing round Aug. 7. The funds will be used to advance its cancer and inflammatory disease pipeline, which include a PD-1/VEGF bispecific antibody, antibody-drug conjugates (ADCs) and a topical Janus kinase inhibitor.
Shanghai Moyom Biotechnology Co. Ltd. has launched its Aphranel Magiccrystal dermal filler, the first injectable calcium hydroxylapatite microsphere-based dermal filler developed in China, and the company is already expanding globally.
Minghui Pharmaceutical Ltd. announced it is raising $131 million in a pre-IPO financing round Aug. 7. The funds will be used to advance its cancer and inflammatory disease pipeline, which include a PD-1/VEGF bispecific antibody, antibody-drug conjugates (ADCs) and a topical Janus kinase inhibitor.
Mabwell (Shanghai) Bioscience Co. Ltd. announced that its Cadherin-17 (CDH17)-targeting antibody-drug conjugate (ADC), 7MW-4911, has received IND clearance to initiate clinical trials from both the U.S. FDA and China's National Medical Products Administration (NMPA).
Cryofocus Medtech (Shanghai) Co. Ltd. received U.S. FDA breakthrough device designation on July 24 for its cryoablation system for asthma. The Chinese med-tech’s stock (HKEX:6922) rose near 20% over two consecutive days on the Hong Kong Stock Exchange with the news, increasing from HK$5.00 ($.64) July 23 to HK$5.98 nearing the close of trading on July 25.
Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized, double-blind, active-controlled (secukinumab) trial enrolled 926 patients with moderate to severe plaque psoriasis.
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
China’s National Medical Products Administration approved Ascentage Pharma Group Corp. Ltd.’s Bcl-2 selective inhibitor lisaftoclax (APG-2575) for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who previously received at least one systemic therapy including Bruton’s tyrosine kinase inhibitors.
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