HUTCHMED Secures $110M Upfront Payment in ATTC Deal with GSK; NMPA Advances 'AI + Drug Regulation'

HUTCHMED is poised to receive $110 million in upfront payment as its KRAS-EGFR antibody-drug conjugate licensing deal with GSK has closed, while China's National Medical Products Administration signaled a regulatory push to integrate artificial intelligence into drug review processes. These developments headline a busy week in China's pharmaceutical sector that also saw regulatory milestones for Ascentage Pharma's Bcl-2 inhibitor, FDA approval for Kingfriend's eribulin formulation, and a landmark functional cure approval for chronic hepatitis B.

HUTCHMED (00013.HK) announced on October 21 that its exclusive licensing agreement with GSK for HMPL-A830 has completed closing following antitrust review. The deal grants the British drugmaker development and commercialization rights outside mainland China, Hong Kong, Macau, and Taiwan for the first-in-class antibody-targeted conjugate, or ATTC. The company expects to receive the $110 million upfront payment shortly, with potential milestone payments of up to $1.185 billion tied to development, regulatory, and commercial sales targets, plus tiered royalties on annual net sales.

HMPL-A830 combines a potent KRAS small-molecule inhibitor as payload with an anti-EGFR antibody, designed to deliver the KRAS inhibitor directly to EGFR-expressing tumors while blocking both EGFR and KRAS signaling pathways. The drug's global Phase Ia clinical trial (NCT07718581) launched in China and the United States in September 2026. HUTCHMED's subsidiary will conduct global Phase I development, while GSK takes over all subsequent clinical development and commercialization in its territories.

The structure of the deal is notable: HUTCHMED retained control of global Phase I development, securing early data ownership while leveraging GSK's resources for later-stage work. The $110 million upfront payment essentially purchases an option on proof-of-concept data, with true value realization contingent on Phase Ia results supporting GSK's further investment.

Meanwhile, China's drug regulator signaled a strategic pivot toward AI-enabled oversight. At a meeting on October 19, NMPA Director Huang Guo called for moving drug evaluation services upstream to the innovation source, drafting special plans to support priority tracks, and creating a regulatory environment that encourages innovation while maintaining prudent oversight. The agency aims to make reviews smarter, inspections more precise, and risk prevention more responsive through AI integration across the drug development lifecycle.

In regulatory developments, Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) announced on October 21 that its Bcl-2 inhibitor lisadotoclax (APG-2575), marketed as Lishengtuo, has received Breakthrough Therapy Designation from China's Center for Drug Evaluation for combination with acalabrutinib in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma. The designation covers adult patients with previously untreated CLL/SLL. Lisadotoclax, approved in China in July 2025 for BTK inhibitor-pretreated CLL/SLL patients, is China's first domestically developed Bcl-2 inhibitor to reach market. The company is conducting four global Phase III registration trials.

Kingfriend (603707.SH) secured FDA approval for its eribulin mesylate injection (1mg/2mL) via ANDA 218930, the company announced October 20. The generic version of Eisai's HALAVEN is indicated for metastatic breast cancer patients who have received at least two prior chemotherapy regimens including anthracyclines and taxanes, as well as unresectable or metastatic liposarcoma following anthracycline-based therapy. The company disclosed approximately 9.16 million yuan in cumulative R&D investment for the project. Ten generic versions of eribulin are already approved in the U.S. market, including those from Sandoz, Natco, Dr. Reddy's, Gland, and Chia Tai Tian Qing.

In financing news, Reju Therapeutics completed an oversubscribed several-hundred-million-yuan Series A round, the company announced October 21. Investors include Cai Hui Fund, Fosun Capital, Yifeng Capital, and Huatai GenScript. The Nanjing-based company, China's first to focus on senotherapeutics, will use proceeds to accelerate clinical-stage programs and expand its technology platform. In March 2026, Reju received IND approvals from both NMPA and FDA for two core programs targeting respiratory and ophthalmic diseases, making it the first Chinese anti-aging innovator to enter clinical-stage development with FDA clearance.

Abbisko Therapeutics (02256.HK) announced October 21 that lavengratinib (ABSK061), its oral selective FGFR2/3 inhibitor, has received Orphan Drug Designation from the European Medicines Agency for achondroplasia. This follows FDA Orphan Drug Designation, Rare Pediatric Disease Designation, and FDA IND clearance for the indication. Lavengratinib, the world's first FGFR2/3 selective inhibitor to enter clinical trials, uses an oral microtablet formulation with each tablet less than 3mm in diameter. The company's Phase II dose-escalation study (ABSK061-202) in children aged 3-12 has shown early positive growth signals with acceptable safety and tolerability.

Sino Biopharm (01177.HK) announced October 21 that its subsidiary Chia Tai Tian Qing has completed enrollment in the Phase III registration trial of TQC2731, a humanized anti-TSLP monoclonal antibody, for chronic rhinosinusitis with nasal polyps. TQC2731 is the first Chinese-developed TSLP antibody to reach Phase III. The company is also conducting a Phase III trial in severe asthma. TSLP, an epithelial cell-derived cytokine, serves as an upstream initiator of inflammatory cascades; blocking TSLP can suppress both Type 2 and non-Type 2 inflammation. Current marketed biologics for CRSwNP primarily target Type 2 inflammation, leaving a treatment gap for non-Type 2 patients.

Suzhou Xinnuowei Pharmaceutical announced October 21 that XNW26018, a novel macrolide antibiotic, has received clinical trial approval from NMPA for community-acquired pneumonia caused by susceptible microorganisms. The Class 1 innovative drug demonstrates broad antibacterial spectrum against major CABP pathogens including Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.

Novo Nordisk's China R&D center launched its INNOVO Open Call on October 21, inviting Chinese researchers to submit innovative target and mechanism projects in diabetes, obesity, cardiovascular disease, nephrology, and MASH. Selected projects receive 350,000 yuan in research funding for 6-9 months of proof-of-concept studies. Researchers retain full intellectual property rights and publication freedom, with access to feedback from Novo Nordisk's global drug discovery experts. The program runs on a rolling basis year-round.

On the global front, GSK's Hibsago (bepirovirsen) received FDA approval on October 20 for chronic hepatitis B, marking the first small nucleic acid drug to complete Phase III studies and gain market approval in the HBV field. The antisense oligonucleotide, combined with nucleos(t)ide reverse transcriptase inhibitors, achieved a functional cure rate of 19% (233 of 1,220 patients) versus 0% (0 of 614) on placebo after six months of treatment, based on pooled data from two Phase III trials (B-Well 1 and B-Well 2). In patients with baseline HBsAg levels at or below 1,000 IU/mL, the functional cure rate reached 26% (200 of 768). GSK acquired Hibsago from Ionis Pharmaceuticals in 2019; Ionis is eligible for additional milestone payments and tiered royalties of 10-12%.

Amgen and AstraZeneca announced positive Phase III CROSSING results for TEZSPIRE (tezepelumab-ekko) in eosinophilic esophagitis on October 20. The study enrolled 368 patients aged 12-80, randomized to receive subcutaneous injections of 210mg, 420mg, or placebo every four weeks. At Week 24, histological remission rates were 64.8% (210mg) and 68.9% (420mg) versus 3.5% placebo (p<0.001). Dysphagia Symptom Questionnaire scores decreased by 18.8 points (210mg) and 22.0 points (420mg) from baseline, compared with 14.7 points for placebo. At Week 52, histological remission was maintained at 67.8% (210mg) and 63.3% (420mg) versus 5.4% placebo. Complete endoscopic remission (EREFS score of 0) was achieved by 29.5% (420mg) and 34.4% (210mg) of patients versus 4.1% placebo. If approved, TEZSPIRE would become the first biologic to simultaneously demonstrate improvement across histology, symptoms, and endoscopic appearance in EoE.