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BioWorld - Tuesday, December 30, 2025
Home » Topics » Regulatory » NMPA

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Remegen’s telitacicept meets phase III endpoints in Sjögren's

Aug. 19, 2025
By Tamra Sami
No Comments
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.
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Remegen’s telitacicept meets phase III endpoints in Sjögren's

Aug. 15, 2025
By Tamra Sami
No Comments
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.
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Floating antibody drug conjugates

Minghui closes $131M pre-IPO round for PD-1/VEGF antibody, ADCs

Aug. 12, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Aphranel Magiccrystal CaHA filler

China’s Moyom Bio goes global in dermal filler market

Aug. 8, 2025
By Tamra Sami
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.
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Floating antibody drug conjugates

Minghui closes $131M pre-IPO round for PD-1/VEGF antibody, ADCs

Aug. 8, 2025
By Marian (YoonJee) Chu
No Comments
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.
Read More
GLP-1 receptor, inactive form vs. active complex with an agonist (semaglutide) and G-proteins
Endocrine/metabolic

Innovent gets IND for oral GLP-1 agonist

Aug. 5, 2025
No Comments
The U.S. FDA has approved Innovent Biologics, Inc.’s IND application to initiate a phase I clinical trial of its oral GLP-1R agonist IBI-3032.
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Cancer

Mabwell receives IND clearance in US and China

Aug. 4, 2025
No Comments

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).


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3D map of China

Cryofocus’ asthma device wins FDA breakthrough label

July 25, 2025
By Marian (YoonJee) Chu
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.
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Skin irritation on hands

Livzon’s IL-17A/F meets phase III endpoints in plaque psoriasis ​

July 22, 2025
By Tamra Sami
No Comments
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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Circode executives
Newco news

Circode applies circRNA to heart disease drug R&D, in vivo CAR T

July 15, 2025
By Marian (YoonJee) Chu
No Comments
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.
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