NMPA

CSPC’s SYS-6051 cleared for clinic in China for solid tumors

Thu, 16 Apr 2026 09:00:00 -0400

CSPC Pharmaceutical Group Ltd.’s SYS-6051 has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for advanced solid tumors. SYS-6051 is a human tissue factor-targeted antibody-drug conjugate that binds to tissue factor expressed on the surface of tumor cells.

China’s NMPA accepts Mabwell’s IND application for 6MW5311

Thu, 16 Apr 2026 09:00:00 -0400

Mabwell (Shanghai) Bioscience Co. Ltd.’s has announced IND acceptance by China’s National Medical Products Administration (NMPA) for the company’s LILRB4/CD3 T-cell engager bispecific antibody 6MW5311. The drug candidate is being developed for hematologic malignancies, specifically acute myeloid leukemia (AML), chronic myelomonocytic leukemia and multiple myeloma.

Mabwell announces Chinese clinical trial clearance for SST-001

Wed, 15 Apr 2026 09:00:00 -0400

Mabwell (Shanghai) Bioscience Co. Ltd. has announced that SST-001 (18F-FD4), an α-synuclein-targeted PET tracer developed by Mabwell’s incubated company Synusight Biotech, has received clinical trial clearance from China’s National Medical Products Administration (NMPA). The planned phase I trial will enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease.

Fosun gains clinical trial approval in China for FXB-0871

Thu, 02 Apr 2026 09:00:00 -0400

Fosun Pharmaceutical (Group) Co. Ltd. has received the approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of FXB-0871 (TEV-56278) for the treatment of locally advanced or metastatic solid tumors.

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD

Tue, 31 Mar 2026 12:00:00 -0400

Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.

Simcere’s rademikibart meets phase III endpoints in atopic dermatitis

Tue, 31 Mar 2026 12:00:00 -0400

Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD

Wed, 25 Mar 2026 12:00:00 -0400

Kintor’s KX-826 meets phase III endpoints in alopecia

Tue, 24 Mar 2026 12:00:00 -0400

Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.

Kelun-Biotech’s SKB-103 cleared to enter clinic in China

Tue, 24 Mar 2026 09:00:00 -0400

Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. has announced IND approval by China’s National Medical Products Administration (NMPA) for SKB-103 for the treatment of advanced solid tumors.

Kintor’s KX-826 meets phase III endpoints in alopecia

Thu, 19 Mar 2026 12:00:00 -0400

China’s Qyuns moves IL-17 biologic toward first approval

Tue, 17 Mar 2026 11:00:00 -0400

Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and sacroiliac joints.

Hightide wins China NDA acceptance for oral metabolic therapy

Tue, 17 Mar 2026 11:00:00 -0400

China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.

CF Pharmtech’s ICF-001 cleared for clinic in China

Mon, 16 Mar 2026 09:00:00 -0400

CF Pharmtech Inc. has announced IND approval by China’s National Medical Products Administration (NMPA) for ICF-001, a long-acting inhalation powder candidate for the treatment of pulmonary hypertension and related severe pulmonary diseases.

China NMPA clears IND for Akeso’s trispecific antibody

Mon, 16 Mar 2026 09:00:00 -0400

Akeso Inc.’s first-in-class trispecific antibody, AK-150, has received IND clearance from China’s National Medical Products Administration (NMPA) for clinical trials in patients with advanced solid tumors. Engineered using Akeso’s AI-driven drug discovery platform and its proprietary Tetrabody technology, AK-150 is a humanized anti-CSF-1R, ILT2 and ILT4 trispecific antibody that achieves multipathway blockade of both innate and adaptive immunity.

China’s Qyuns moves IL-17 biologic toward first approval

Wed, 11 Mar 2026 12:00:00 -0400

Hightide wins China NDA acceptance for oral metabolic therapy

Wed, 11 Mar 2026 12:00:00 -0400

China approves first noninvasive therapy for cervical precancer

Tue, 10 Mar 2026 12:00:00 -0400

China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.

China’s NMPA clears HBM-7575 to enter clinic in atopic dermatitis

Mon, 09 Mar 2026 09:00:00 -0400

Harbour Biomed Ltd. and Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. have announced IND approval by China’s National Medical Products Administration (NMPA) for HBM-7575 (SKB-575) for the treatment of atopic dermatitis.

China’s NMPA clears China Medical System’s CMS-D008 for clinic

Fri, 06 Mar 2026 08:00:00 -0500

China Medical System Holdings Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for CMS-D008 injection for overweight or obese individuals.

China approves first noninvasive therapy for cervical precancer

Wed, 04 Mar 2026 12:00:00 -0500

UCB inks $1.1B deal for Antengene’s autoimmune bispecific TCE

Wed, 04 Mar 2026 12:00:00 -0500

Belgian pharma giant UCB SA is putting skin in the bispecific T-cell engager (TCE) game, announcing a potential $1.1 billion deal to license Antengene Corp.’s ATG-201. ATG-201 is a CD19/CD3 bispecific TCE antibody aimed at autoimmune disorders, though specific indications were not disclosed.

Systimmune’s iza-bren hits phase III breast cancer goals in China

Tue, 03 Mar 2026 12:00:00 -0500

In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer.

Jiuyuan seeks approval of Wegovy biosimilar in China

Tue, 03 Mar 2026 12:00:00 -0500

China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.

China clears first JAK/ROCK drug for myelofibrosis

Tue, 03 Mar 2026 12:00:00 -0500

China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rovadicitinib, branded as Anxu, for first-line treatment of adults with intermediate- or high-risk primary myelofibrosis, as well as post polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

Systimmune’s iza-bren hits phase III breast cancer goals in China

Fri, 27 Feb 2026 12:00:00 -0500

Jiuyuan seeks approval of Wegovy biosimilar in China

Thu, 26 Feb 2026 12:00:00 -0500

CF Pharmtech’s ICF-004 cleared for clinical trials in China

Thu, 26 Feb 2026 08:00:00 -0500

CF Pharmtech Inc. has announced approval from China’s National Medical Products Administration (NMPA) of an IND application filed by subsidiary Changfeng Suyue Pharmaceutical (Guangzhou) Co. Ltd. for ICF-004.

Takeda’s oral narcolepsy drug steps closer to FDA approval

Tue, 24 Feb 2026 11:00:00 -0500

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.

NMPA clears Gensci-136 for trials in immunoglobulin A nephropathy

Mon, 16 Feb 2026 08:00:00 -0500

Changchun Genescience Pharmaceutical Co. Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to start clinical trials with Gensci-136 for injection, a dual APRIL/BAFF antagonist in development for the treatment of immunoglobulin A nephropathy.

Takeda’s oral narcolepsy drug steps closer to FDA approval

Wed, 11 Feb 2026 12:00:00 -0500