This week’s China healthcare highlights include ProteLight Pharmaceuticals’ Hong Kong IPO application featuring its NDA-ready carbapenem-class drug PL-5, Sino Biopharm’s US$ 1.5B global licensing deal with Sanofi for JAK/ROCK inhibitor rovadicitinib, and Antengene’s US$ 1.2B partnership with UCB for its CD19/CD3 T-cell engager ATG-201. Beijing Wehand-Bio filed for a Hong Kong IPO to expand commercialization of Sang Borne®, China’s first plant-derived α-glucosidase inhibitor for type 2 diabetes. Key milestones include Eli Lilly’s IL-13 inhibitor Ebglyss submitted for China approval, Sciwind’s approval for first-in-class GLP-1 agonist ecnoglutide for weight management, and Immorna’s srRNA-based IL-12 therapy JCXH-211 advancing to Phase II trials. These developments highlight China’s innovation in biotech IPOs, partnerships, and clinical advances.

Transactions

ProteLight Pharmaceuticals: Advancing Antimicrobial Peptide Therapeutics for Unmet Global Needs

Key Words: ProteLight Pharmaceuticals, antimicrobial peptides, AMP, PL-5, PL-3301, PL-18, drug development, anti-infection, metabolic diseases, oncology, autoimmune diseases

The News: ProteLight Pharmaceuticals has submitted its prospectus for a proposed IPO on the Hong Kong Main Board. The company, established in 2006, focuses on four core therapeutic areas: anti-infection, metabolic diseases, oncology, and autoimmune diseases.

Key Highlights:

• Core Product:
  • PL-5 (Peleganan): The first carbapenem-class drug to globally file an NDA, based on ProteLight’s “Membrane Differentiation Mechanism” theory. It disrupts microbial membrane integrity to combat antibiotic resistance and offers broad-spectrum, high-efficacy treatment for multidrug-resistant infections. Included in China’s 12th and 13th “Major New Drug Innovation” projects.
• Key Products:
  • PL-3301: A first-in-class thermosensitive peptide gel for oral candidiasis, in Phase Ia trials in China and FDA-approved for Phase I in the US (2024).
  • PL-18: A first-in-class AMP for vulvovaginal candidiasis (VVC) and other gynecological infections, in Phase II trials in China and FDA-approved for Phase II in the US.
• According to its prospectus, ProteLight reported revenues of RMB 5.19 million in 2024 and RMB 2.96 million for the first nine months of 2025, with net losses of RMB 158 million and RMB 101 million for the same periods, respectively.

Sino Biopharm (1177.HK) Licenses First-in-Class JAK/ROCK Inhibitor to Sanofi in US$ 1.5 Billion Deal

Key Words: Sino Biopharm, Sanofi, rovadicitinib, JAK/ROCK inhibitor, global license, myelofibrosis, cGVHD, breakthrough therapy designation

The News: Sino Biopharmaceutical, through its subsidiary Chia Tai Tianqing, has signed a global licensing agreement with Sanofi for rovadicitinib, a first-in-class oral JAK/ROCK inhibitor. The deal, valued at up to US$ 1.53 billion, grants Sanofi (SNY: NASDAQ) exclusive rights to develop, manufacture, and commercialize the drug worldwide. Sino Biopharm will receive an upfront payment of US$ 135 million, with additional development, regulatory, and sales milestone payments, as well as tiered royalties of up to the double-digit percentage range on annual net sales. The agreement is subject to customary closing conditions, including regulatory approvals.

Key Highlights:

• Deal Details:
  • Total deal value: Up to US$ 1.53 billion.
  • Upfront payment: US$ 135 million.
  • Additional payments: Development, regulatory, and sales milestones, plus tiered royalties up to double digits.
• Rovadicitinib’s Profile:
  • Recently received marketing approval in China (February 2026) for the first-line treatment of high-risk forms of myelofibrosis.
  • Targets both JAK/STAT and ROCK signaling pathways, offering a novel mechanism of action for modulating immune responses.
• Broader Development Potential:
  • Currently in clinical studies for chronic graft-versus-host disease (cGVHD), where it has received breakthrough therapy designation (BTD) in China.
  • Being evaluated in combination regimens, with positive early-phase data reported for cGVHD.

Antengene (6996.HK) Licenses CD19/CD3 TCE to UCB for Up to US$ 1.2 Billion

Key Words: Antengene, UCB, ATG-201, CD19/CD3 TCE, bispecific antibody, AnTenGager platform, licensing agreement

The News: Antengene has signed an exclusive global licensing agreement with UCB for its CD19/CD3 bispecific T-cell engager (TCE), ATG-201. The deal includes an upfront and near-term milestone payment of US$ 80 million, with additional potential development and commercial milestone payments exceeding US$ 1.1 billion. Antengene will also receive tiered royalties on future net sales. UCB gains exclusive global rights to develop, manufacture, and commercialize the bispecific antibody, which is based on Antengene’s proprietary AnTenGager platform.

Key Highlights:

• Deal Details:
  • Total deal value: Up to US$ 1.2 billion.
  • Upfront and near-term milestone payments: US$ 80 million.
  • Additional payments: Over US$ 1.1 billion in development and commercial milestones, plus tiered royalties on net sales.
• ATG-201 is designed with steric hindrance shielding technology to enhance safety by masking the CD3 binding arm until it engages the CD19 target on B-cells, aiming to provide precise and potent intervention for B-cell-driven diseases.
• Antengene plans to submit clinical trial applications for ATG-201 in China and Australia in Q1 2026 and will conduct the initial Phase I studies, after which UCB will take over responsibility for all subsequent global development and commercialization.
• The AnTenGager platform is a proprietary technology that has generated a pipeline of nine other disclosed candidates, showcasing Antengene’s innovative approach to advancing bispecific antibody therapeutics on a global scale.

Beijing Wehand-Bio Files for HK IPO: Pioneering Natural Diabetes Drug Development

Key Words: SZ-A (Sang Borne®), α-glucosidase inhibitor, NRDL, WH002, paclitaxel-cholesterol conjugate, neoadjuvant, luminal BC, PCOS

The News: Beijing Wehand-Bio has filed for a Hong Kong IPO to accelerate commercialization of its flagship drug/Sang Borne® (SZ-A) – China’s first plant-derived α-glucosidase inhibitor for type 2 diabetes (NMPA 2020; NRDL 2021). The company reported RMB 480 million (US$66M) in 2025 revenue for SZ-A, leveraging patented purification technology.

Key Highlights:

• Core Product:
  • Sang Borne®: Approved in 2020 as China’s first, and the world’s first, plant-derived, multi-component drug for Type 2 diabetes. It delays dietary glucose absorption and activates AMPK pathways to enhance tissue sugar utilisation in a multi-target botanical mechanism.
• Key Products:
  • WH002: It is an investigational tumor-targeting paclitaxel-cholesterol conjugate lipid emulsion, is being developed for neoadjuvant treatment of Luminal breast cancer to enhance tumor accumulation and therapeutic efficacy.
• Wehand-Bio transcends traditional biotech with its dual-thrust model: leveraging Sang Borne®’s cash flow to de-risk WH002’s oncology advancement while deploying PhytoScreen® to capture 30% of China’s botanical drug market by 2029.

Clinical

Eli Lilly (NYSE: LLY) Submits First IL-13 Inhibitor for Approval in China

Key Words: Eli Lilly, Ebglyss, lebrikizumab, IL-13 inhibitor, atopic dermatitis, NDA, Phase III trials

The News: Eli Lilly has submitted a New Drug Application (NDA) in China for its IL-13 inhibitor, Ebglyss (lebrikizumab), targeting moderate-to-severe atopic dermatitis. This submission marks the first IL-13 monoclonal antibody (mAb) seeking regulatory approval in the Chinese market. Ebglyss, approved in Europe (2023) and the US (2024), generated approximately US$ 408 million in global sales in 2025. The therapy works by binding to soluble IL-13 with high affinity, blocking the cytokine’s role in inflammatory pathways associated with atopic dermatitis.

Key Highlights:

• Clinical Data Supporting NDA:
  • Submission is based on positive results from two Phase III trials, ADvocate 1 and ADvocate 2.
  • In these studies, a significantly higher proportion of patients treated with lebrikizumab achieved clear or almost clear skin (IGA 0/1) and a 75% improvement in eczema area and severity (EASI-75) compared to placebo at 16 weeks.
• Ebglyss’s Global Success:
  • Approved in Europe (2023) and the US (2024).
  • US$ 408 million in global sales in 2025, reflecting strong demand in existing markets.
• First IL-13 monoclonal antibody to seek approval in China.

Chia Tai Tianqing (3839.HK) Gains China Approval for First-in-Class Myelofibrosis Drug

Key Words: Chia Tai Tianqing, rovadicitinib, myelofibrosis, JAK/ROCK inhibitor, first-in-class, JAK-STAT pathway, Phase II trials

The News: Chia Tai Tianqing has received marketing approval in China for rovadicitinib, a first-in-class oral JAK/ROCK inhibitor, for the treatment of adults with intermediate-2 or high-risk primary myelofibrosis, post-polycythaemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. The approval covers the first-line treatment of patients with disease-related splenomegaly or symptoms. Rovadicitinib works by inhibiting both JAK family kinases and ROCK kinases, targeting the JAK-STAT signaling pathway to modulate disease progression.

Key Highlights:

• Clinical Data Supporting Approval:
  • Approval is based on positive Phase II trial results presented at the European Society for Medical Oncology (ESMO) 2024 congress.
  • The data demonstrated superior efficacy of rovadicitinib compared to hydroxyurea in reducing spleen volume and improving total symptom scores at 24 weeks.
  • Safety profile was consistent with other drugs in the JAK inhibitor class.
• Therapeutic Innovation:
  • Rovadicitinib is the first-in-class dual JAK/ROCK inhibitor approved in China, offering a novel mechanism of action.
  • Current JAK inhibitors are standard-of-care but do not reverse disease progression, while rovadicitinib aims to address this unmet medical need.
• Broader Development Potential:
  • Rovadicitinib is also being evaluated in combination therapies.
  • Received breakthrough therapy designation (BTD) for chronic graft-versus-host disease, highlighting its potential in other indications.

Sciwind Gains Approval for First-in-Class Biased GLP-1 Agonist in China

Key Words: Sciwind Biosciences, ecnoglutide, GLP-1 receptor agonist, cAMP-biased signalling, weight management, obesity, SLIMMER Phase III

The News: Sciwind Biosciences has received marketing authorisation in China for ecnoglutide, a first-in-class cAMP-biased GLP-1 receptor agonist, for the long-term management of weight in adults with overweight or obesity. The novel therapy employs a biased signalling mechanism designed to selectively activate the cAMP pathway, achieving an average weight reduction of 15.4% (15.1% when adjusted for placebo) over 48 weeks in a Chinese Phase III trial. Notably, 92.8% of participants achieved a clinically meaningful weight loss of 5% or more.

Key Highlights:

• Clinical Data Supporting Approval:
  • Approval is based on the positive SLIMMER Phase III trial conducted in China.
  • Ecnoglutide achieved an average weight reduction of 15.4% over 48 weeks, with 92.8% of participants achieving at least 5% weight loss.
  • Demonstrated significant improvements in key cardiometabolic risk markers, including waist circumference, blood pressure, lipids, liver fat content, and insulin resistance.
• Dual-Indication Launch:
  • Ecnoglutide was previously approved in China in January 2026 for type 2 diabetes (T2D).
  • This latest approval for weight management completes a strategic dual-indication launch in the metabolic disease sector.
• Utilizes a first-in-class cAMP-biased signalling mechanism, selectively targeting the cAMP pathway for enhanced efficacy and safety in weight management.

Immorna’s srRNA-Based IL-12 Therapy JCXH-211 Prepares for Phase II Trials

Key Words: Immorna, JCXH-211, self-replicating RNA (srRNA), IL-12, tumor immunotherapy, cold tumors, clinical trial

The News: Immorna, a clinical-stage biotechnology company, announced that its self-replicating RNA (srRNA) therapy, JCXH-211, targeting IL-12, is set to enter Phase II clinical trials. JCXH-211 is the first domestically developed RNA-based therapy to receive clinical trial approvals in both China and the US and represents a potential first-in-class treatment for tumors, particularly “cold tumors” with strong immunosuppressive environments.

Key Highlights:

• JCXH-211 leverages Immorna’s srRNA platform to enable high and sustained IL-12 expression in tumors, overcoming the short half-life and systemic toxicity challenges of traditional IL-12 therapies. Its dual mechanism combines innate immune activation from srRNA replication with IL-12-mediated antitumor immune modulation, turning “cold tumors” into “hot tumors.”
• Preclinical and Clinical Data:
  • Preclinical studies demonstrated significant efficacy in cold tumor models, with a single dose reversing tumor growth in B16-F10 models.
  • Phase I trials showed robust intratumoral immune cell infiltration and a high disease control rate with strong safety and tolerability, even at the highest dose (200 µg).
  • In combination with PD-1 antibodies, JCXH-211 achieved complete response in target lesions at low doses, maintained for over 36 weeks.
• JCXH-211’s tumor-targeted expression significantly reduces systemic exposure, widening its safety window and enabling intravenous administration, a unique advantage over other IL-12 therapies.
• Founded in 2019, Immorna specializes in developing RNA-based therapeutics and vaccines using its proprietary RNA platforms, including self-replicating, circular, and traditional mRNA technologies. The company has established robust CMC manufacturing capabilities and developed various delivery systems, such as polymer and lipid nanoparticle (LNP) carriers, to support clinical and commercial development.

Pfizer’s (NYSE: PFE) Ecnoglutide Approved in China for Long-Term Weight Management

Key Words: Pfizer, ecnoglutide, weight management, NMPA approval, SLIMMER study, obesity, overweight

The News: Pfizer Inc. announced that the National Medical Products Administration (NMPA) has approved ecnoglutide for long-term weight management in adults with overweight or obesity in China.

Key Highlights:

• Clinical Efficacy:
  • The SLIMMER Phase III study demonstrated an average weight reduction of 15.4% at 48 weeks for the 2.4mg dose group.
  • 8% of participants achieved at least 5% weight loss.
  • Sustained weight loss was observed over 48 weeks without a plateau phase.
• The drug exhibited good safety and tolerability, with gastrointestinal adverse events being mostly mild to moderate. The treatment discontinuation rate was low at 2%.
• Ecnoglutide also improved waist circumference, liver fat content, blood pressure, lipids, and glucose, further supporting its benefits for overall metabolic health.

Roche’s (SWX: ROG) Baloxavir Marboxil Gains Expanded Indication Approval in China

Key Words: Roche, baloxavir marboxil, influenza treatment, pediatric approval, MINISTONE-2, DRAGONSTONE

The News: Roche Holding AG announced the approval of baloxavir marboxil for expanded indications in China. The drug is now approved for treating uncomplicated influenza A and B in pediatric patients aged 1 to under 5 years (dry suspension), including healthy patients and those at high risk for complications. Additionally, baloxavir marboxil tablets are approved for pediatric patients aged 5 to 12 years with a high risk of influenza-related complications.

Key Highlights:

• The expanded indications broaden the treatment age range from 5 years and older to 1 year and older, now covering infants, children, and adults.
• Approvals are supported by data from the MINISTONE-2 and DRAGONSTONE studies, which showed good tolerability and efficacy in children aged 1 to under 12 years.
• These approvals provide new therapeutic options for young pediatric patients, addressing unmet needs in influenza management.

PersonGen BioTherapeutics Receives Clinical Trial Approval for New Indication of PA3-17

Key Words: PersonGen, PA3-17, CD7-targeted CAR-T, pediatric T-ALL/LBL, breakthrough therapy designation, clinical trial

The News: PersonGen BioTherapeutics (Suzhou) Co., Ltd., has received clinical trial approval for a new indication of PA3-17 (autologous) for the treatment of pediatric and adolescent relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL).

Key Highlights:

• Product Profile:
  • PA3-17 (autologous) is the world’s first CD7-targeted CAR-T cell therapy to receive IND approval.
  • It has been granted “breakthrough therapy designation” by the Center for Drug Evaluation (CDE).
• Currently in a pivotal Phase II clinical trial for adult R/R T-ALL/LBL patients.
• The approval expands its applicable patient population to include pediatric and adolescent patients, marking a significant milestone in its clinical development.

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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