This week’s China healthcare highlights include Novartis announcing over RMB 3.3 billion investment to enhance R&D and manufacturing in China, with a focus on upgrading its Changping facility and Shanghai campus. Insilico Medicine partnered with Eli Lilly in a US$ 2.75 billion AI drug discovery deal, while Adicon Pharmaceuticals plans an IPO to advance its HIV pipeline with next-gen integrase inhibitors. Two siRNA firms, RigeRNA and Leaderna, secured over RMB 350 million to advance candidates for IgAN, hypertension, and metabolic diseases. Everest Medicines completed an asset purchase deal with Corxel Pharmaceuticals for etripamil nasal spray to treat PSVT and AFib-RVR in China, and CStone reported promising Phase I data for its PD-1×VEGF×CTLA-4 trispecific CS2009, targeting NSCLC and other advanced cancers. These developments highlight China’s growing role in innovative biopharma advancements.

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Novartis (NOVN.S) Plans Over RMB 3.3 Billion Investment in China

Key Words: Novartis, China investment, manufacturing expansion, R&D, Shanghai campus, business development

The News: Novartis announced plans to invest over RMB 3.3 billion (US$ 480 million) to expand its R&D, manufacturing, and operational footprint in China. The investment will support both infrastructure upgrades and long-term innovation capabilities, reinforcing the company’s strategic commitment to China as a key growth market. The move also aligns with Novartis’s broader efforts to strengthen local development, accelerate clinical execution, and deepen partnerships with domestic biotech companies.

Key Highlights:

• Deal Details:
  • RMB 1.5 billion for upgrading its Changping manufacturing facility.
  • RMB 1.8 billion to support Phase II development of its Shanghai campus.
• Strategic Significance:
  • China is Novartis’s second-largest global market.
  • Expansion will increase clinical trial capacity and accelerate global pipeline development.
• Business Development Focus:
  • Continued collaboration with Chinese biotech firms.
• Since 2024, partnerships represent potential investments exceeding RMB 80 billion across multiple therapeutic areas.

Insilico Medicine (3696.HK) Partners with Eli Lilly (LLY.N) in up to US$ 2.75 Billion AI Drug Discovery Deal

Key Words: Insilico Medicine, Eli Lilly, AI drug discovery, Pharma.AI, licensing, collaboration, oral therapy

The News: Insilico Medicine has entered into a global licensing and AI-driven drug discovery collaboration with Eli Lilly, combining its generative AI platform with Lilly’s clinical development capabilities to accelerate the discovery and development of innovative therapies across multiple therapeutic areas. As part of the agreement, Lilly will obtain exclusive global rights to develop, manufacture, and commercialize a novel oral candidate generated by Insilico’s proprietary Pharma.AI platform, currently in preclinical development and with potential to be best-in-class.

Key Highlights:

• Deal Details:
  • Total deal value: Up to US$ 2.75 billion.
  • Upfront payment: US$ 115 million.
  • Milestones: Development, regulatory, and commercial payments up to ~US$ 2.75 billion.
• Pipeline Licensing:
  • Lilly gains exclusive global rights to a preclinical-stage oral candidate.
  • Asset generated using Insilico’s Pharma.AI platform.
• AI Collaboration Scope:
  • Multi-target discovery collaboration across selected targets by Lilly.
  • Insilico to leverage Pharma.AI and automated lab capabilities for molecule design and optimization.
  • Lilly to contribute expertise in disease biology and clinical development.

Adicon Pharmaceuticals Plans Hong Kong IPO to Advance HIV Pipeline

Key Words: Adicon Pharmaceuticals, IPO, Hong Kong, HIV, integrase inhibitor, ACC017, ADC118

The News: Adicon Pharmaceuticals, a China-based company focused on HIV therapeutics, is reportedly planning an IPO in Hong Kong. The company has established a comprehensive anti-HIV portfolio spanning innovative and generic drugs, covering the full treatment cycle from first-line therapy to drug-resistant settings and prevention. Proceeds from the planned listing are expected to support the continued development of its pipeline, including late-stage clinical programs targeting next-generation HIV therapies.

Key Highlights:

• Financing Details:
  • Fundraising plan: up to RMB 1.277 billion.
  • ~RMB 767 million (>60%) allocated to global multi-centre clinical development.
  • Focus on advancing next-generation HIV integrase inhibitors.
• Pipeline Overview:
  • Commercial-stage asset: Ainuomiti.
  • Recently approved: Dolutegravir sodium tablets.
  • Broad portfolio covering treatment and prevention across HIV lifecycle.
• Core Clinical Programs:
  • ACC017: Novel integrase inhibitor currently in Phase III clinical trials
  • ADC118: Triple combination regimen based on ACC017
  • Potential advantages vs second-generation integrase inhibitors, including lower systemic exposure, reduced dosing, and faster viral load reduction
• Operates in a competitive domestic landscape with key players including Desano, Beck, and Qilu Pharmaceutical and reflects continued investment interest in HIV therapeutics in China

Two siRNA Companies Secure New Funding Totalling Over RMB 350 Million

Key Words: RigeRNA, Leaderna Therapeutics, siRNA, financing, Pre-A, Series A, IgA nephropathy, hypertension, metabolic disease

The News: Two Chinese biotech companies focused on small interfering RNA (siRNA) therapeutics, RigeRNA and Leaderna Therapeutics, announced new financing rounds on the same day, raising a combined total of over RMB 350 million. The proceeds will be used to advance their clinical-stage pipelines across renal, cardiovascular, and metabolic diseases. The transactions underscore continued investor interest in nucleic acid-based therapeutics, particularly as companies work to overcome delivery challenges and expand applications beyond traditional liver-targeted indications.

Key Highlights:

• RigeRNA Financing:
  • Over RMB 200 million raised in a Pre-A round led by Bayland Capital.
  • Lead siRNA candidate for IgA nephropathy (IgAN) currently in Phase II clinical development.
  • Additional pipeline programs in early-stage development targeting kidney and metabolic diseases.
• Leaderna Therapeutics Financing:
  • RMB 150 million raised in a Series A round led by Tao Capital.
  • Funds will advance its core siRNA pipeline, including:
    • A twice-yearly dosed hypertension candidate (Phase II).
    • A metabolic disease candidate to reduce fat while preserving muscle mass.
  • Built on three proprietary oligonucleotide delivery platforms.

Everest Medicines (1952.HK) Enters into Asset Purchase Agreement with Corxel Pharmaceuticals for CARDAMYST™ (Etripamil) Nasal Spray in Greater China

Key Words: Everest Medicines, Corxel Pharmaceuticals, CARDAMYST™, Etripamil, PSVT, AFib-RVR, calcium channel blocker, Greater China

The News: Everest Medicines has entered into an Asset Purchase Agreement with Corxel Pharmaceuticals to develop, manufacture, and commercialize CARDAMYST™ (etripamil) nasal spray in Greater China. CARDAMYST™, a rapid-acting, self-administered calcium channel blocker, was FDA-approved in December 2025 for the treatment of PSVT. Everest will pay Corxel US$ 30 million upfront, with up to US$ 20 million in milestone payments.

Key Highlights:

• Clinical Data:
  • FDA-approved in December 2025 for PSVT, supported by the Phase 3 RAPID study.
  • JX02002 Phase 3 China study achieved primary endpoints, demonstrating a significant conversion to sinus rate within 30 minutes (hazard ratio [HR] = 3.02; p=0.0005).
  • Phase 3 RAPID trial: 64% of participants receiving etripamil converted from SVT to sinus rhythm within 30 minutes (HR = 2.62; p<0.001).
• Product Advantages:
  • First and only FDA-approved self-administered nasal spray for PSVT, shifting treatment from emergency settings to patient-managed care.
  • Rapid onset of action, favorable tolerability, and suitability for at-home use.
• Market Opportunity:
  • PSVT affects 3–6 million patients in China, with no existing non-injectable, self-administered therapies.
  • Etripamil is under development for atrial fibrillation with rapid ventricular response (AFib-RVR), which affects nearly 20 million patients in China.
• Next Steps:
  • NDA for etripamil accepted by China’s National Medical Products Administration (NMPA) in January 2025, with approval expected in Q3 2026.
  • Phase III development for AFib-RVR planned, based on promising Phase II results.

Clinical

CStone (2616.HK) Reports Promising Early Data for PD-1×VEGF×CTLA-4 Trispecific

Key Words: CStone Pharmaceuticals, trispecific antibody, CS2009, PD-1, VEGF, CTLA-4, oncology, Phase I

The News: CStone Pharmaceuticals reported updated early-stage clinical data for its PD-1×VEGF×CTLA-4 trispecific antibody CS2009, demonstrating encouraging anti-tumour activity and a manageable safety profile in patients with advanced solid tumours. The data, generated from a global Phase I study, support the potential of trispecific antibody approaches to simultaneously target multiple tumour and immune pathways, positioning CS2009 as a differentiated candidate in the increasingly competitive immuno-oncology landscape.

Key Highlights:

• Clinical Data:
  • Phase I: enrolled 113 patients with advanced solid tumours.
  • Achieved 90% ORR in a small cohort of treatment-naive NSCLC patients with high PD-L1 expression.
  • No dose-limiting toxicities observed.
• Safety Profile:
  • Well tolerated overall.
  • Low incidence of severe VEGF-related adverse events.
• Development Progress:
  • Advanced into Phase II trials (85 patients enrolled).
  • Positive safety data in combination with chemotherapy.
• Next Steps:
  • Phase III trials planned (NSCLC, CRC, SCLC) by end of 2026.
  • Additional data expected at major oncology conferences.

Huanbo’s Novel PAH Drug AF02 Gains IND Clearance in China, US

Key Words: Huanbo Biotechnology, AF02, IND, pulmonary arterial hypertension, first-in-class, cardiovascular

The News: Huanbo Biotechnology has received investigational new drug (IND) clearance from both China and US regulators for its novel pulmonary arterial hypertension (PAH) candidate AF02, enabling the initiation of global multi-centre clinical trials. The dual regulatory approvals mark a key milestone for the company and reflect the growing trend of Chinese biotech firms advancing innovative therapies through parallel global development pathways.

Key Highlights:

• Regulatory Milestone:
  • IND approvals from both China CDE and US regulators.
  • Enables global multi-centre clinical trials.
• Mechanism & Innovation:
  • First-in-class therapy targeting vascular remodelling.
  • Potential to address root causes rather than symptoms of PAH.
• Pipeline Expansion Potential:
  • Being explored for heart failure and diabetes.
  • Reflects broader cardiovascular disease strategy.

Yuyan Pharma’s Recombinant Botulinum Toxin Approved in China

Key Words: Yuyan Pharma, Retoxin, botulinum toxin type A, recombinant protein, NMPA approval, aesthetics, neurology

The News: Yuyan Pharma announced that its recombinant botulinum toxin type A product, Retoxin (YY001), has been approved by China’s NMPA for the treatment of moderate-to-severe glabellar lines in adults. The product represents the first approved recombinant botulinum toxin globally, marking a shift from traditional extraction-based production to recombinant manufacturing. The approval is supported by positive multi-centre clinical data in China and positions the company to expand into broader neurological indications.

Key Highlights:

• Regulatory Milestone:
  • Approved in China for moderate-to-severe glabellar lines.
  • First recombinant botulinum toxin to reach commercialization globally.
• Technology Innovation:
  • Developed using a recombinant expression platform.
  • Avoids biosafety risks associated with botulinum toxin production.
  • Demonstrates high purity, strong biological activity, and low immunogenicity.
• Clinical Performance:
  • Supported by randomized, double-blind, placebo- and active-controlled multi-centre studies in China.
  • Met all primary clinical endpoints.
  • Showed improved efficacy, safety profile, and reduced immunogenicity.
• Pipeline Expansion:
  • Phase III: ongoing for adult upper limb spasticity.
  • Phase II: completed with positive results.

3SBio’s (1530.HK) SSS68 Receives US IND Approval for IgA Nephropathy Treatment

Key Words: 3SBio, SSS68, US IND, APRIL/BAFF, IgA nephropathy, bispecific antibody

The News: 3SBio has received IND approval from the US FDA for SSS68, China’s first bispecific antibody targeting APRIL/BAFF for IgA nephropathy. This approval marks a significant regulatory milestone, enabling SSS68 to begin clinical trials and offering new hope for patients with unmet needs in autoimmune disease treatment.

Key Highlights:

• Regulatory Milestone:
  • IND approval by the US FDA allows global clinical trials for SSS68.
  • This represents a major step forward for China’s innovative biologics development.
• Mechanism & Innovation:
  • SSS68 is a tetravalent bispecific antibody that simultaneously targets and neutralizes BAFF and APRIL, two cytokines critical in autoimmune disease pathways.
  • Its unique dual-target mechanism suppresses B-cell activation, proliferation, and autoantibody production, addressing the root cause of IgA nephropathy.
• Clinical Potential:
• SSS68 offers improved disease modulation compared to single-target therapies, reducing disease activity and relapse risk.
• It is expected to provide better long-term outcomes for patients while advancing treatment for autoimmune and nephrological diseases.

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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