The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.
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.
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.
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