This week’s China healthcare highlights include Lilly’s US$345M AI-driven BsAb licensing deal with XtalPi, IVACTA’s RMB 100M fundraising for in vivo CAR-T therapies, Vigonvita’s HKD 5.873B IPO with 4,974x oversubscription, and Neurocrine’s US$881M global licensing of TransThera’s NLRP3 inhibitors. Clinical breakthroughs feature HighTide’s positive Phase III results for HTD1801 in diabetes, Keymed’s CM512 Phase I success in atopic dermatitis, Curegene’s non-GLP-1 weight-loss drug CG-0416, BRL’s 100% ORR with PD1-CAR-T therapy in lymphoma, and Novartis’ Pluvicto® approval in China for advanced prostate cancer.

Transactions & BD (In/Out Licensing)

Lilly (NYSE: LLY) Enters US$ 345 Million BsAb Collaboration with XtalPi

Key Words: Eli Lilly, XtalPi, Ailux, BsAb, AI, drug discovery

The News: Eli Lilly has expanded its strategic partnership with China-based XtalPi through its wholly owned subsidiary Ailux in a potential US$ 345 million agreement, including a multi-million-dollar upfront payment and near-term milestones, for bispecific antibody (BsAb) discovery and development across multiple therapeutic areas. The collaboration leverages Ailux’s AI antibody platform combining computational design with high-throughput experimental validation to accelerate candidate optimisation and pre-clinical development.

Key Highlights:

• AI-Driven Discovery: The collaboration utilizes Ailux’s AI platform, which integrates quantum physics modelling, generative design, and developability analysis through a multimodal biologics database to design antibodies with novel functions and optimal drug-like properties.
• Strategic Fit: Lilly can nominate multiple target pairs for BsAb engineering, with Ailux eligible for platform access fees and development, regulatory, and commercial milestones.
• Partnership Expansion: This agreement builds on the 2023 US$ 250 million small-molecule drug discovery collaboration between Lilly and XtalPi, reinforcing Lilly’s commitment to AI-enabled pharmaceutical research and development.

IVACTA Biotech Completes Over 100 Million RMB Financing, Driving In Vivo CAR-T Innovation in China

Key Words: IVACTA Biotech, in vivo CAR-T, lipid nanoparticle, autoimmune diseases, hematologic malignancies

The News: IVACTA Biotech Co., Ltd. (Shanghai) has successfully completed its angel financing round, raising over 100 million RMB. The round was led by Qiming Venture Partners, with participation from B Capital, Xingze Capital, and Shunxi Fund. The funds will be used to optimize the company’s core technology platform and accelerate the clinical development of its first candidate product for autoimmune diseases.

Key Highlights:

• Innovative Platform: IVACTA Biotech’s in vivo CAR-T therapies utilize a targeted lipid nanoparticle (LNP) delivery system, enabling direct CAR expression within patient T cells without requiring traditional autologous CAR-T processes like cell separation, expansion, or lymphodepletion.
• Addressing Key Challenges: The technology simplifies treatment, overcoming conventional CAR-T limitations such as high costs, long treatment cycles, and significant toxicity, while improving patient accessibility by transforming cell therapies into off-the-shelf drug products.
• Strategic Focus: Founded on June 25, 2025, as a spinoff from Grit Biotechnology (Beijing), IVACTA aims to develop breakthrough therapies for hematologic malignancies and autoimmune diseases.

Vigonvita Life Sciences (2630.HK) Goes Public on HKEX with 4,974 Times Oversubscription

Key Words: Vigonvita Life Sciences, IPO, HKEX, small-molecule drugs, neurology, psychiatry, reproductive health

The News: Vigonvita Life Sciences, a Chinese biopharmaceutical company, successfully listed on the Hong Kong Stock Exchange (HKEX) on November 6, 2025, with CITIC Securities as the sole sponsor. The IPO was oversubscribed by 4,974 times, highlighting strong investor enthusiasm. The IPO price was set at HKD 33.37, giving the company a valuation of approximately HKD 5.873 billion.

Key Highlights:

• Massive Oversubscription: The public offering was oversubscribed by 4,974 times.
• Strong Grey Market Performance: Opened at HKD 61.25 (up 83.55%) and closed at HKD 85.80 (up 157.12%).
• Global Offering: Vigonvita issued 17.5978 million H-shares, with 90% allocated to international investors and 10% to public offering.
• About Vigonvita: Founded in 2013, Vigonvita focuses on developing innovative small-molecule drugs for neurology, psychiatry, and reproductive health. Its key products include LV232, a depression treatment in Phase I preparation, and TPN171, approved for erectile dysfunction with plans to expand to cognitive disorders. The company’s pipeline includes multiple candidates in clinical and preclinical development.

Neurocrine Biosciences (NBIX.O) Signs US$ 881 Million Licensing Deal with TransThera Sciences (2617.HK) for NLRP3 Inhibitors

Key Words: Neurocrine Biosciences, TransThera Biosciences, TT-00420, NLRP3 inflammasome, metabolic diseases, inflammatory diseases

The News: Neurocrine announced a licensing agreement with China’s TransThera on November 3, 2025, worth up to $881 million. The deal grants Neurocrine exclusive global rights (excluding Greater China, including Hong Kong, Macau, and Taiwan) to develop and commercialize TransThera’s TT-00420 series, a small-molecule drug candidate targeting the inflammasome system for metabolic and inflammatory diseases.

Key Highlights:

• Agreement Details: TransThera will receive upfront and milestone payments totalling up to US$ 881 million, plus royalties on sales outside of Greater China, where it retains commercialization rights.
• Promising Candidate: TT-00420 has shown strong preclinical efficacy in inflammasome-related diseases, including nonalcoholic hepatosteatosis, cardiovascular disease, and diabetes.
• Market Context: The NLRP3 inflammasome, a key immune regulator, has become a high-interest target for metabolic and inflammatory diseases. Other players like NodThera and Ventyx Biosciences are advancing NLRP3 inhibitors, with recent clinical progress in Parkinson’s disease and obesity-related inflammation.

Clinical Development

Shenzhen HighTide Biopharmaceutical (2511.HK) Announces Positive Phase III Results for HTD1801 in Type 2 Diabetes

Key Words: HighTide Biopharmaceutical, HTD1801, T2DM, Phase III, cardio-renal benefits

The News: Shenzhen-based HighTide Biopharmaceutical Co., Ltd. announced the successful completion of two global Phase III trials (SYMPHONY-1 and SYMPHONY-2) for its first-in-class anti-inflammatory metabolic modulator, HTD1801, in the treatment of Type 2 Diabetes Mellitus (T2DM). The trials confirmed sustained 52-week efficacy and safety, building on significant results observed during the initial 24-week double-blind period.

Key Highlights:

• Improved Outcomes: HTD1801 achieved mean HbA1c reductions of -1.2% (monotherapy) and -1.1% (combination with metformin) at Week 52, along with cardio-renal benefits such as LDL-C reductions and eGFR stabilization.
• Favorable Safety: Long-term treatment was well-tolerated, with no significant safety concerns, positioning HTD1801 as a promising therapy for T2DM patients with comorbidities.
• Next Steps: HighTide plans to submit a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) within the year, aiming to address unmet needs in diabetes management with a dual-action therapy targeting both inflammation and metabolic dysregulation.

Keymed Biosciences (2162.HK) Announces Phase I Results for Long-Acting TSLP x IL-13 Bispecific Antibody CM512 in Moderate-to-Severe Atopic Dermatitis

Key Words: Keymed, CM512, TSLP, IL-13, Type 2 inflammation, atopic dermatitis

The News: Keymed announced that its first-in-class long-acting TSLP x IL-13 bispecific antibody, CM512, has achieved all primary endpoints in a Phase I clinical study (CM512-100001) for moderate-to-severe atopic dermatitis (AD) in adults. The results highlight CM512’s rapid disease control, deep and sustained symptom relief, and an exceptional 70-day half-life, with a favorable safety profile.

Key Highlights:

• Improved Outcomes: CM512 demonstrated rapid and durable efficacy, with 50% of patients in the 300mg group achieving EASI-75 at Week 6, and 58.3% achieving EASI-75 and 41.7% achieving EASI-90 at Week 12, significantly outperforming placebo.
• Favorable Safety: CM512 was well-tolerated across all dose levels, with no dose-limiting toxicities or serious adverse events (SAEs) reported, and a safety profile comparable to placebo.
• Next Steps: The 70-day half-life supports extended dosing intervals, and Phase II/III trials will further evaluate its efficacy, safety, and dosing, positioning it as a potential best-in-class therapy for Type 2 inflammation-driven diseases.

Moving Beyond GLP-1: Curegene Unveils Breakthrough Oral Weight Loss Drug CG-0416 at Obesity Week 2025

Key Words: Curegene Pharmaceuticals, CG-0416, weight loss, non-GLP-1, obesity, THR-β agonist

The News: At Obesity Week 2025, Curegene presented preclinical data on CG-0416, a next-generation, non-GLP-1 oral weight-loss drug. As a liver-targeted thyroid hormone receptor β (THR-β) agonist, CG-0416 offers a novel mechanism of action with potent fat reduction, muscle preservation, and oral administration, surpassing the limitations of current GLP-1-based therapies.

Key Highlights:

• High-Quality Weight Loss: Preclinical studies showed 95% fat loss with minimal muscle loss, a significant improvement over semaglutide, which caused one-third of weight loss from muscle reduction.
• Synergistic Combination Therapy: Combined with GLP-1 agonists, CG-0416 boosted weight loss efficacy from 24% to 40% while mitigating muscle loss and reducing GLP-1-related side effects.
• Revolutionizing Obesity Treatment: CG-0416’s non-GLP-1 mechanism, combined with oral convenience, addresses critical unmet needs in weight loss therapy and offers new hope for patients with severe obesity.
• Future Outlook: Curegene’s CG-0416 has the potential to set a new standard in obesity management, both as a standalone therapy and in combination with GLP-1 agonists, offering deep weight loss, improved metabolic health, and enhanced patient compliance.

BRL Medicine Achieves 100% ORR with Non-Viral Site-Specific PD1-CAR-T Therapy for Lymphoma, First Patient Cancer-Free for Over 5 Years

Key Words: BRL Medicine, CAR-T, PD1, non-Hodgkin lymphoma, non-viral therapy, BRL-201

The News: BRL Medicine announced that its non-viral PD1 site-specific CAR-T therapy, BRL-201, achieved 100% objective response rate (ORR) and 85.7% complete response rate (CR) in a study treating relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The long-term follow-up data will be presented at the 67th American Society of Hematology (ASH) Annual Meeting in December 2025. Notably, the first patient treated with BRL-201 has remained cancer-free for over 5 years.

Key Highlights:

• Exceptional Outcomes: The study, involving 21 patients, achieved 100% ORR with zero Grade 2 or higher cytokine release syndrome (CRS) or neurotoxicity.
• Innovative Technology: BRL-201 uses non-viral site-specific integration, eliminating the risks and costs of viral vectors while boosting CAR-T cell persistence and activity.
• Impact on B-NHL: Non-Hodgkin lymphoma (NHL) frequently recurs following initial treatment, posing significant challenges for patients. BRL-201’s groundbreaking efficacy and safety provide new hope for those battling refractory and relapsed forms of this disease.

Umoja Biopharma and Nona Biosciences Deepen Collaboration on In Vivo CAR-T Therapies

Key Words: Umoja Biopharma, Nona Biosciences, in vivo CAR-T, VivoVecTM, HCAb Harbour Mice®

The News: On November 5, 2025, Nona Biosciences, a subsidiary of Harbour Biomed (2142.HK), announced a new evaluation and licensing agreement with Umoja Biopharma, a leader in in vivo cell therapy. This partnership builds on their September 2024 collaboration, aiming to advance in vivo CAR-T therapies by integrating Nona’s HCAb Harbour Mice® and NonaCarFxTM platforms with Umoja’s VivoVecTM delivery platform.

Key Highlights:

• Innovative Platforms: Umoja’s VivoVecTM enables efficient delivery, stable expression, and precise targeting, while Nona’s HCAb Harbour Mice® provides fully human heavy-chain antibodies as modular components for CAR-T, mRNA, and other therapies.
• Pipeline Progress: Umoja’s UB-VV111 (targeting CD19) and UB-VV400/410 (targeting CD22) are in Phase I clinical trials, addressing B-cell malignancies, NHL, and autoimmune diseases.
• Strategic Synergy: This collaboration leverages cutting-edge technologies to develop next-generation in vivo CAR-T therapies, enhancing safety, efficacy, and scalability.

Novartis’ (NYSE: NVS) Blockbuster Radioligand Therapy Approved for Two Indications in China

Key Words: Novartis, Pluvicto®, [¹⁷⁷Lu] Lutetium-PSMA-617, PSMA, mCRPC, radioligand therapy

The News: Novartis announced the approval of its radioligand therapy Pluvicto® ([¹⁷⁷Lu] Lutetium-PSMA-617) in China for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The therapy is approved for adult patients who have disease progression following androgen receptor pathway inhibitors (ARPI) and are suitable for delayed chemotherapy, as well as for those who have progressed after receiving both ARPI and taxane-based chemotherapy. As the first and only PSMA-targeting radioligand therapy approved in China, Pluvicto® offers a novel treatment option for late-stage prostate cancer patients, with the potential to extend survival and improve quality of life.

Key Highlights:

• VISION Trial: A global Phase III study demonstrated significant improvements in overall survival (OS) (15.3 vs. 11.3 months; HR 0.62) and radiographic progression-free survival (rPFS) (8.7 vs. 3.4 months; HR 0.40) when [¹⁷⁷Lu] Lutetium-PSMA-617 was added to the best standard of care (bSOC).
• PSMAfore Trial: Another Phase III study showed that [¹⁷⁷Lu] Lutetium-PSMA-617 extended rPFS by 6 months (11.60 vs. 5.59 months; HR 0.49), with higher objective response rates (ORR) (50% vs. 15%) and complete response (CR) (21% vs. 4%).
• Quality of Life Improvement: Both trials demonstrated significant delays in quality-of-life deterioration and pain worsening, with fewer grade ≥3 adverse events compared to standard treatments.

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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