This week’s China healthcare highlights include GSK’s $50M partnership with LTZ for myeloid cell engagers, Kind Pharma’s RMB 400M+ Series C for anemia and breast cancer programs, and Phrontline’s $60M funding to advance bispecific ADCs. Clinical breakthroughs feature BeOne’s zanidatamab + tislelizumab combo significantly improving survival in HER2+ GEA, Sichuan Biokin’s iza-bren meeting PFS/OS endpoints in esophageal cancer, and Kangpu’s KPG-818 achieving 50% ORR in r/r MM. Additionally, YolTech secured FDA IND clearance for YOLT-203, a gene-editing therapy for PH1; Abbisko’s pimicotinib reached 76.2% ORR in TGCT; and Innovent’s mazdutide demonstrated up to 20.1% weight loss in obesity, with NDA filing underway.

Transactions & BD (In/Out Licensing)

GSK plc (LSE/NYSE: GSK) Partners with LTZ in US$ 50 Million Collaboration for Next-Gen Cancer Therapies

Key Words: GSK, LTZ, myeloid cell engagers (MCEs), oncology, immunotherapy, cancer treatment

The News: GSK has entered a US$ 50 million collaboration with LTZ Therapeutics to develop up to four first-in-class myeloid cell engagers (MCEs) targeting haematologic cancers and solid tumours. The agreement includes an upfront payment, milestone payments, and royalties, with GSK gaining exclusive global licensing rights.

Key Highlights:

• Innovative Platform: LTZ’s MCE platform leverages myeloid cells to target and destroy tumour cells, offering a safer profile suitable for community-based care.
• Addressing Unmet Needs: MCEs provide a novel approach to immuno-oncology, overcoming limitations of current treatments such as severe side effects.
• Strategic Fit: The partnership aligns with GSK’s efforts to develop transformative cancer therapies using next-generation technologies.

Kind Pharmaceutical Secures RMB 400m+ in Series C for Anaemia and Cancer Programs

Key Words: Kind Pharma, Series C funding, AND017, CKD, anaemia, AND019, breast cancer, drug development

The News: Kind Pharma, a China-based company, has raised over RMB 400 million in Series C funding led by CGE Healthcare. The funding will support the clinical development of its lead candidates, including AND017, an oral small molecule for chronic kidney disease (CKD)-induced anaemia, and AND019, a third-generation selective estrogen receptor degrader for breast cancer.

Key Highlights:

• AND017 Development: Following successful multinational Phase II trials, AND017 is advancing into a Phase III registrational trial for CKD-induced anaemia, with parallel Phase II studies ongoing for sickle cell disease (SCD) and myelodysplastic syndromes (MDS).
• Innovative Approach: AND017 offers weekly oral dosing, improving compliance over injectable erythropoiesis-stimulating agents and providing safety advantages compared to HIF-PH inhibitors in renal anaemia.
• AND019 in Breast Cancer: The second lead asset, AND019, features a novel chemical structure inducing protein self-degradation, currently in Phase I trials.
• Pipeline Expansion: Kind Pharma’s pipeline includes pre-clinical small molecules and antibody-drug conjugates (ADCs) targeting additional indications.

Phrontline Biopharma Secures US$60 Million in Pre-A+ Funding to Advance Bispecific ADC Development

Key Words: Phrontline Biopharma, bispecific ADC, Pre-A+ funding, TJ101, precision oncology, global collaboration

The News: Phrontline Biopharma, a next-generation antibody-drug conjugate (ADC) R&D company, announced the completion of its US$ 60 million Pre-A+ funding round. The round was led by Longpan Investment, with participation from Samsung Venture Investment Corporation, CSPC NIF Fund, and other high-profile investors. Existing investors, including Decheng Capital and M Square Health Fund, also increased their stakes. The funds will support the global clinical development of Phrontline’s innovative bispecific and dual-payload ADC pipeline.

Key Highlights:

• Innovation Platform: Founded in 2022, Phrontline Biopharma is pioneering bispecific antibody ADCs (BsAb-ADCs) and dual-payload ADCs. The company has built a robust platform for antibody discovery, linker-payload design, site-specific conjugation, and functional evaluation. Its pipeline includes nearly ten programs, with TJ101, an EGFR/B7-H3-targeting bispecific ADC, currently enrolling patients in clinical trials in both the U.S. and China.
• Strategic Collaborations:
  • Samsung Bioepis Partnership (October 2025): Joint development of two bispecific dual-toxin ADCs with differentiated mechanisms of action.
  • China Biopharma Licensing Deal (October 2025): Licensing of TJ101 for mainland China and Hong Kong, including upfront, milestone, and royalty payments, advancing TJ101’s global clinical development.
• Funding Significance: The successful funding round reflects strong market confidence in Phrontline’s innovative ADC platform, robust pipeline, and global strategy.

Clinical Development

BeOne’s (6160.HK, 688235.SS, NASDAQ: ONC) HER2+ GEA Combo Demonstrates Significant Survival Benefit

Key Words: BeOne, HER2-positive, zanidatamab, tislelizumab, gastroesophageal adenocarcinoma, PFS, OS

The News: BeOne announced that the Phase III HERIZON-GEA-01 trial met its dual primary endpoints, with the combination of zanidatamab (a HER2-targeted bispecific antibody) and tislelizumab (a PD-1 inhibitor) showing statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to trastuzumab plus chemotherapy in 914 patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).

Key Highlights:

• Clinical Benefits: The combination demonstrated improved objective response rate (ORR) and duration of response (DOR), supporting its potential as a new first-line standard of care for HER2+ GEA.
• Patient Subgroups: Clinical benefits were observed across both PD-L1-positive and -negative patient subgroups.
• Safety Profile: The safety profile was consistent with individual agents, with no new safety signals reported.

Sichuan Biokin’s (688506.SH) Bispecific ADC Achieves Dual Endpoints in Phase III Esophageal Cancer Trial

Key Words: Sichuan Biokin, iza-bren, EGFR×HER3, ADC, esophageal cancer, PFS, OS

The News: Biokin announced that the Phase III trial of iza-bren (EGFR×HER3 bispecific ADC) for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) met its dual primary endpoints of progression-free survival (PFS) and overall survival (OS). The study, BL-B01D1-305, was conducted in patients who had failed prior PD-1/PD-L1 antibody and platinum-based chemotherapy treatments. The independent data monitoring committee (iDMC) confirmed the positive results.

Key Highlights:

• First-in-Class Achievement: This marks the world’s first Phase III trial where an antibody-drug conjugate (ADC) has demonstrated dual positive PFS and OS results in esophageal cancer treatment.
• Global Development: Iza-bren, described as a first-in-class EGFR×HER3 bispecific ADC, is under investigation in over 40 clinical trials across China and the US for various tumor types.
• Regulatory Milestones: The drug has received 7 breakthrough therapy designations in China and 1 in the US, highlighting its innovative potential.

Kangpu Biopharmaceuticals Presents Promising Phase I Results for KPG-818 at 67th ASH Annual Meeting

Key Words: Kangpu Biopharmaceuticals, KPG-818, Phase I, hematological malignancies, multiple myeloma, ASH 2025

The News: Kangpu announced Phase I clinical trial results for epaldeudomide (KPG-818), a novel cereblon (CRBN) modulator, at the 67th American Society of Hematology (ASH) Annual Meeting. The study evaluated KPG-818 as monotherapy or in combination with dexamethasone in patients with relapsed/refractory multiple myeloma (r/r MM) and other hematologic malignancies.

Key Highlights:

• Efficacy: In heavily pre-treated r/r MM patients, KPG-818 achieved an overall response rate (ORR) of 50% and a disease control rate (DCR) of 94%.
• Safety Profile: The drug demonstrated good safety and tolerability, with no reports of febrile neutropenia or peripheral neuropathy of any grade.
• Mechanism of Action: KPG-818, a molecular glue modulator of the CRL4-CRBN complex, showed strong CRBN binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), key transcription factors in B-cell development.

YolTech Therapeutics Secures FDA IND Clearance for Global Trial of Gene-Editing Therapy YOLT-203

Key Words: YolTech, YOLT-203, gene-editing therapy, PH1, FDA, IND clearance, Orphan Drug Designation

The News: YolTech announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for YOLT-203, an in vivo gene-editing therapy for treating Primary Hyperoxaluria Type 1 (PH1). The company will initiate a global, multicenter, randomized, double-blind, placebo-controlled pivotal trial to evaluate YOLT-203’s safety and efficacy in reducing urinary oxalate levels and improving renal outcomes.

Key Highlights:

• Orphan Designations: YOLT-203 has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the U.S. FDA, along with Orphan Drug Designation from the EMA.
• Innovative Approach: YOLT-203 is designed as a once-and-done in vivo gene-editing therapy targeting the HAO1 gene to deactivate glycolate oxidase (GO), reducing oxalate overproduction in PH1 patients.
• Trial Goals: The pivotal trial will be the first of its kind for PH1, focusing on long-term renal outcomes and durable therapeutic benefit.
• About YolTech Therapeutics: YolTech leverages next-generation CRISPR/Cas and lipid nanoparticle (LNP) technologies to develop transformative, in vivo gene-editing therapies targeting rare genetic, metabolic, cardiovascular, and autoimmune diseases.

Abbisko Therapeutics Presents Promising Long-Term Data for Pimicotinib in TGCT at CTOS 2025

Key Words: Abbisko Therapeutics, pimicotinib, TGCT, CSF-1R inhibitor, Phase III MANEUVER study, CTOS 2025

The News: Abbisko presented long-term efficacy, safety, and patient-reported outcomes (PROs) data for pimicotinib, a novel CSF-1R inhibitor, in tenosynovial giant cell tumor (TGCT) patients at the CTOS 2025 Annual Meeting. The Phase III MANEUVER study demonstrated sustained and improved tumor responses over time.

Key Highlights:

• Efficacy: The objective response rate (ORR) increased from 54.0% at Week 25 to 76.2% after a median follow-up of 14.3 months, including four complete responses. Patients initially on placebo who switched to pimicotinib achieved an ORR of 64.5%.
• Patient-Reported Outcomes (PROs): Clinically meaningful improvements were observed in pain, physical function, and quality of life (QoL), with a 13.1% increase in the VAS score above baseline by Week 73.
• Safety: Pimicotinib maintained an acceptable safety profile, with most treatment-emergent adverse events (TEAEs) being Grade 1-2, and no new safety signals reported.

Innovent Biologics’ (1801.HK) Mazdutide 9 mg Achieves Up to 20.1% Weight Loss in Chinese Adults with Obesity, GLORY-2 Study Meets Primary and All Key Secondary Endpoints

Key Words: Mazdutide, GLORY-2, weight loss, obesity, GLP-1 receptor agonist, Innovent Biologics

The News: Innovent, a leading biopharmaceutical company, announced that the Phase 3 clinical trial of mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese adults with obesity (GLORY-2) has successfully met the primary endpoints and all key secondary endpoints. Innovent plans to submit the new drug application (NDA) for mazdutide 9 mg for weight management to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

Key Highlights:

• GLORY-2 Study Overview: GLORY-2 (NCT06164873) is a Phase 3 clinical trial evaluating the efficacy and safety of mazdutide 9 mg combined with lifestyle interventions versus placebo in Chinese adults with obesity (BMI ≥30 kg/m²). The study enrolled 462 participants, including 16% with type 2 diabetes, randomized 2:1 to receive mazdutide or placebo during a 60-week double-blind treatment period (mean baseline weight: 94.0 kg; mean BMI: 34.3 kg/m²).
• Weight Loss and Metabolic Impact:

         At Week 60:

• The mazdutide 9 mg group achieved a mean weight reduction of 18.55%, compared to 02% in the placebo group.
• Among participants without type 2 diabetes, the mazdutide group reached a 08% mean weight reduction, with 48.7% achieving a weight loss of 20% or more, compared to 3.1% in the placebo group (P<0.0001).
• Significant improvements were also observed in waist circumference, blood lipids, blood pressure, liver fat content, and other metabolic parameters.
• Safety Profile: Mazdutide demonstrated a favorable safety profile, with most gastrointestinal adverse events being mild to moderate and transient.

Prepared by the Selesta Research Team.

research@selesta.ai

Selesta is a healthcare and life science advisory firm dedicated to serving Asia’s emerging entrepreneurs and businesses.

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