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BioWorld - Monday, June 8, 2026
Home » Topics » Regulatory » NMPA

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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.
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Concept art for systemic lupus erythematosus R&D
Immuno-oncology

CSPC’s SYS-6063 gains Chinese trial clearance for SLE

June 3, 2026
No Comments
CSPC Pharmaceutical Group Ltd. has obtained clinical trial clearance from China’s National Medical Products Administration (NMPA) for SYS-6063, an mRNA-LNP-based dual-target CAR T-cell injection for the treatment of relapsed or refractory systemic lupus erythematosus (SLE).
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Cybersecurity data lock

China launches long-awaited drug data protection rules

June 2, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards.
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HKEX on phone, digital stock chart

Longbio to raise HK$1.4B in Hong Kong IPO for immunology work

June 2, 2026
By Tamra Sami
No Comments
Chinese biotech Longbio Pharma Co. Ltd. announced its IPO on the Hong Kong Stock Exchange to raise HK$1.362 billion (US$174 million) to progress its lead candidate, LP-003, a next-generation anti-IgE antibody.
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China map/flag with silhouettes of business people

China deals highlight biopharma evolution, reports LEK

June 2, 2026
By Tamra Sami
No Comments
In 2025, China’s outbound life sciences and biopharma deals reached nearly $100 billion, about 12 times the level seen in 2021, underscoring how quickly global appetite for Chinese assets has accelerated, according to a recent report by L.E.K. Consulting.
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Cybersecurity data lock

China launches long-awaited drug data protection rules

May 29, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards.
Read More
Floating antibody drug conjugates

TROP2 ADCs progress into first-line for lung, breast cancers

May 28, 2026
By Marian (YoonJee) Chu
No Comments
Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics.
Read More
HKEX on phone, digital stock chart

Longbio to raise HK$1.4B in Hong Kong IPO for immunology work

May 28, 2026
By Tamra Sami
No Comments
Chinese biotech Longbio Pharma Co. Ltd. announced its IPO on the Hong Kong Stock Exchange to raise HK$1.362 billion (US$174 million) to progress its lead candidate, LP-003, a next-generation anti-IgE antibody.
Read More
Floating antibody drug conjugates

TROP2 ADCs progress into first-line for lung, breast cancers

May 28, 2026
By Marian (YoonJee) Chu
No Comments
Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics.
Read More
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