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BioWorld - Tuesday, June 16, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Woman holding tissue to nose with plants, pollen

Longbio’s LP-003 meets phase III allergy endpoints

June 15, 2026
By Tamra Sami
No Comments
After raising HK$1.255 billion (US$160 million) in its IPO on the Hong Kong Stock Exchange earlier this month, Longbio Pharma Co. Ltd.’s lead candidate, LP-003, met the primary endpoint of total nasal symptom scores during peak pollen season in moderate to severe seasonal allergic rhinitis.
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Blood glucose chart and monitor, stethoscope, injector pen

Chinese challenger Gan & Lee gains momentum in metabolic disease

June 15, 2026
By Tamra Sami
No Comments
Chinese diabetes specialist Gan & Lee Pharmaceuticals is strengthening its position in metabolic disease after reporting positive phase III data for both once-weekly basal insulin candidate Ludefen and obesity therapy bofanglutide.
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Liver anatomy

Oricell brings first pivotal-stage CAR T in liver cancer

June 12, 2026
By Tamra Sami
No Comments
Oricell Therapeutics Holdings Ltd.’s glypican-3 (GPC3)-targeted autologous CAR T therapy, Ori-C101, is heading into a confirmatory registration phase II trial in patients with GPC3-positive advanced hepatocellular carcinoma, positioning it as the first GPC3-directed immune cell therapy – and the first CAR T therapy for liver cancer – to reach that stage of development.
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Stomach cross-section on scientific background

China clears Alphamab’s HER2 bispecific antibody in gastric cancer

June 11, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), through priority review for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received at least one trastuzumab-containing regimen.
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Hands holding gears

Three deals in six days: Everest builds late-stage APAC portfolio

June 10, 2026
By Tamra Sami
No Comments
Fresh off a deal with Travere Therapeutics Inc. for civorebrutinib worth more than $1.14 billion, Everest Medicines Ltd. went on a shopping spree, striking three deals in six days to expand its pipeline and geographic reach across Asia Pacific.
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3d rendering of bispecific antibodies
Immune

Antengene’s ATG-201 gains IND clearance in China

June 10, 2026
No Comments
Antengene Corp. Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) for ATG-201 for the treatment of B-cell related autoimmune diseases.
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Gastric cancer

Innovent submits NDA for CLDN18.2 ADC for gastric cancer

June 9, 2026
By Tamra Sami
No Comments
Innovent Biologics Co. Ltd.’s Claudin18.2-targeted antibody-drug conjugate (ADC), arcotatug tavatecan (IBI-343, TAK-921), met the primary endpoint in the international multicenter phase III G-Hope-001 trial in advanced gastric cancer, according to interim results.
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Red wooden approved stamp

NMPA gives conditional nods to drugs by Lupeng, Vcare, Staidson

June 9, 2026
By Marian (YoonJee) Chu
No Comments
China’s National Medical Products Administration (NMPA) on June 4 granted conditional approvals to two oncology drugs from Lupeng Pharmaceutical Co. Ltd. and Vcare Pharmatech Co. Ltd., as well as one hemophilia drug developed by Staidson Biopharmaceutical Co. Ltd.
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Art concept for tumor
Cancer

China’s NMPA clears Hansoh’s HS-10541 for clinic

June 8, 2026
No Comments
Hansoh Pharmaceutical Group Co. Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for HS-10541 tablets.
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Gastric cancer

Innovent submits NDA for CLDN18.2 ADC for gastric cancer

June 4, 2026
By Tamra Sami
No Comments
Innovent Biologics Co. Ltd.’s Claudin18.2-targeted antibody-drug conjugate (ADC), arcotatug tavatecan (IBI-343, TAK-921), met the primary endpoint in the international multicenter phase III G-Hope-001 trial in advanced gastric cancer, according to interim results.
Read More
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