This week’s biotech updates include InnoCare and Eli Lilly’s $3.35B licensing deal for five programs, BoomRay licensing a preclinical radioligand therapy to Novartis for $900M, and Henlius partnering with Amberstone for conditional T-cell engagers worth $236M. Clinical milestones include Hansoh’s TYK2 inhibitor meeting Phase III endpoints in plaque psoriasis and IASO Biotherapeutics reporting strong Phase I results for in vivo BCMA CAR-T IASO206.

Transactions & BD (In/Out Licensing)

InnoCare (688428.SH) and Eli Lilly (LLY.N) Sign Discovery and Licensing Collaboration Worth Up to US$ 3.35 Billion for Up to Five Programs

Key Words: InnoCare, Eli Lilly, drug discovery, licensing, research collaboration, novel targets, milestones, royalties

• The News: InnoCare announced a research collaboration and license agreement with Eli Lilly to discover and develop up to five programs against novel targets addressing unmet medical needs. InnoCare will use its proprietary drug-discovery platform and research capabilities to advance the collaboration. It is eligible for up to US$ 100 million in combined upfront and near-term payments and approximately US$ 3.25 billion in potential development and commercialization milestones. Additional tiered royalties are payable on annual net sales of licensed products.
• Key Highlights:
• Key details of the transaction:
  • Scope: Discovery and development of up to five innovative target programs.
  • Upfront and Near-Term Payments: Up to US$100 million in aggregate; the standalone upfront amount was not disclosed.
  • Milestones: Approximately US$25 billion in potential development and commercialization payments, subject to applicable conditions and milestone achievement.
  • Total Potential Consideration: Up to approximately US$35 billion before royalties; the full amount is not guaranteed.
  • Royalties: Tiered single-digit percentage royalties on annual net sales of licensed products.
• Platform Profile – InnoCare Drug Discovery:
  • Contribution: InnoCare’s proprietary discovery platform and research expertise will support target-based program discovery and development.
  • Program Disclosure: Specific targets, asset identities, indications and individual program stages were not disclosed in the announcement.

Insilico Medicine (3696.HK) Signs Collaboration Worth Tens of Millions of US Dollars to Develop Foundation Models for Biology

Key Words: Insilico Medicine, MMAI Gym, foundation models, generative biology, biologics, gene editing, enzyme engineering, research collaboration

• The News: Insilico Medicine announced a collaboration valued at tens of millions of US dollars with an undisclosed frontier foundation-model laboratory. The partners will combine the laboratory’s generative model architecture with Insilico’s MMAI Gym training framework, scientific reasoning data and experimental validation capabilities to develop and commercialize models for biological research.
• Key Highlights:
• Key details of the collaboration:
  • Deal Value: Tens of millions of US dollars; the payment schedule and revenue-sharing percentages were not disclosed.
  • Partner: An unnamed frontier foundation-model laboratory.
  • Commercialization: The partners plan to share revenues from resulting AI products and draw on their respective global biopharmaceutical relationships.
• Research priorities:
  • Biologics: Design and optimization of antibodies, nanobodies, peptides and other binders, with attention to function and developability.
  • Gene Editing and Enzymes: Exploration of promptable models for new gene-editing tools and de novo enzyme design for biocatalytic and therapeutic applications.
  • Optimization: Iterative testing of sequence novelty, structural feasibility, activity and target-binding strength.
• Platform Profile – MMAI Gym:
  • Approach: Combines task-specific scientific data with a training framework and closed-loop wet-lab validation.
  • Development Objective: Build and validate models suited to specialized biological research tasks, with experimental feedback used to refine model outputs.

BoomRay Licenses Undisclosed Preclinical Radioligand Therapy to Novartis in Deal Worth Up to US$ 900 Million

Key Words: BoomRay, Novartis, radioligand therapy, RLT, oncology, preclinical, global license, milestones

• The News: BoomRay announced an exclusive global license agreement with Novartis for an undisclosed preclinical radioligand therapy (RLT). BoomRay is eligible for up to US$ 900 million in upfront and milestone payments, plus royalties on future global net sales. The agreement combines BoomRay’s discovery and development capabilities with Novartis’RLT expertise.
• Key Highlights:
• Key details of the transaction:
  • Rights: Exclusive global license to one preclinical RLT asset.
  • Economics: Up to US$900 million, comprising an upfront payment and development, regulatory and sales milestones; the upfront amount was not separately disclosed.
  • Royalties: Additional royalties on future global net sales; the rate was not disclosed.
• Product Profile – Undisclosed RLT Asset:
  • Licensed RLT Asset: A preclinical radioligand therapy developed by BoomRay and licensed to Novartis for global development.
  • Mechanism: The asset-specific target, isotope and molecular mechanism have not been disclosed.
  • Indication Focus: Oncology; specific tumor indications have not been disclosed.
  • Development Stage: Preclinical at the time of the licensing announcement.
• BoomRay: A Suzhou-based biotechnology company developing radioligand therapies for oncology diagnosis and treatment.

Henlius (2696.HK) Licenses Two Conditional T-Cell Engager Programs from Amberstone, with Up to US$ 236.16 Million

Key Words: Henlius, Amberstone Biosciences, T-MATE, T-cell engager, conditional activation, solid tumors, global license, research collaboration

• The News: Henlius and Amberstone Biosciences entered a global exclusive collaboration and license agreement to develop two conditional T-cell engager (TCE) products directed at specified tumor targets. The programs will use Amberstone’s T-MATE platform, which is designed to activate T-cell engagement preferentially in the acidic tumor microenvironment. The disclosed payment package includes up to US$ 4 million upfront and up to US$ 232.16 million in research fees and development and regulatory milestones.
• Key Highlights:
• Key details of the license:
  • Scope: Exclusive, sublicensable worldwide rights to research, develop, manufacture and commercialize two collaboration products.
  • Disclosed Payment Categories: Up to US$16 million in aggregate upfront, research, development and regulatory payments; this subtotal excludes separately described commercial economics.
  • Responsibilities: Amberstone will construct preclinical candidates using T-MATE; Henlius will lead subsequent development, manufacturing and commercialization.
• Platform Profile – T-MATE:
  • Technology: A pH-dependent conditional antibody platform designed to favor activation in acidic tumor tissue while limiting activity under normal physiological conditions.
  • Objective: Broaden the therapeutic window of solid-tumor TCEs by reducing unwanted T-cell activation outside tumors.
  • Evidence Stage: Preclinical platform findings do not establish clinical safety or efficacy for the two licensed programs; disclosed pipeline examples should not be assumed to be the licensed assets.

Earendil Labs and Genentech Enter Oncology Bispecific Antibody Collaboration Worth More Than US$ 1.5 Billion

Key Words: Earendil Labs, Genentech, Roche, bispecific antibodies, oncology, AI biologics, research collaboration, milestones

• The News: Earendil Labs announced a research collaboration with Genentech, a Roche Group company, to discover and develop multiple therapeutic bispecific antibody programs in oncology. Earendil will lead antibody discovery and research through early clinical development for pre-agreed target combinations, while Genentech will assume subsequent global clinical development and commercialization. Earendil is to receive US$ 55 million upfront and may receive additional milestone payments, bringing total potential consideration to more than US$ 1.5 billion, plus royalties.
• Key Highlights:
• Key details of the collaboration:
  • Upfront Payment: US$55 million.
  • Potential Value: More than US$5 billion including upfront, development, regulatory and sales milestones; the full amount depends on achievement of the applicable conditions.
  • Royalties: Earendil is also eligible for royalties on product net sales; rates were not disclosed.
  • Program Scope: Multiple oncology bispecific antibody programs against pre-agreed target combinations; individual targets were not disclosed.
• Platform Profile – Earendil Biologics Discovery:
  • Approach: Integrates predictive protein modeling, generative protein design and high-throughput experimental validation.
  • Application: Discovery and optimization of differentiated biologics, including bispecific antibodies intended to address complementary aspects of tumor biology.
• Earendil Labs: An AI-driven biotechnology company developing next-generation biologics through predictive protein modeling, generative protein design and high-throughput experimental validation.
• Genentech: A member of the Roche Group and a leading biotechnology company focused on discovering, developing and commercializing innovative medicines for serious diseases.

Wangao Pharmaceutical Commits RMB 50 Million to ABA001 siRNA Co-Development with Sun-Novo

Key Words: Wangao Pharmaceutical, Sun-Novo, ABA001, siRNA, AGT, GalNAc, hypertension, co-development

• The News: Beijing Sun-Novo Pharmaceutical Research announced a co-development agreement with Jiangsu Wangao Pharmaceutical for ABA001, an investigational siRNA therapy for hypertension. Wangao will invest RMB 50 million in the current funding tranche to support domestic clinical trials, development optimization, regulatory submissions and related compliance activities.
• Key Highlights:
• Key details of the agreement:
  • Funding: RMB50 million in the current tranche, earmarked for ABA001 project activities in China.
  • China Rights: Wangao receives exclusive domestic commercialization rights, with economic participation linked to actual funding contributions.
  • Ex-China Rights: The parties will share overseas co-development, licensing and commercialization interests in proportion to actual investment.
• Product Profile – ABA001:
  • ABA001: An investigational AGT-targeting siRNA developed by Sun-Novo, using GalNAc conjugation for delivery to liver cells.
  • Mechanism: Silences angiotensinogen (AGT) mRNA to reduce AGT protein synthesis and suppress the blood-pressure-raising effects of the renin-angiotensin-aldosterone system.
  • Indication Focus: Hypertension.
  • Development Stage: In Phase I clinical development, with the collaboration supporting further trials, regulatory submissions and commercialization preparation.
• Evidence and development objectives:
  • Preclinical Findings: The report describes blood-pressure lowering at 1 mg/kg in nonclinical studies.
  • Dosing Objective: Administration every three to six months is a development aspiration, not a clinically established regimen for ABA001. Results for other AGT-targeting siRNAs cannot establish ABA001’s efficacy or safety.
• Wangao Pharmaceutical: A China-based pharmaceutical company engaged in the development, manufacturing and commercialization of generic and innovative medicines.

Biokin’s (688506.SH) BL-B01D1 Program Triggers Second US$ 250 Million Contingent Payment from Bristol Myers Squibb

Key Words: Biokin Pharmaceutical, SystImmune, Bristol Myers Squibb, BL-B01D1, EGFR, HER3, bispecific ADC, contingent payment

• The News: Biokin Pharmaceutical disclosed that its global pivotal Phase III IZABRIGHT-Lung02 trial of BL-B01D1 had achieved a contractual milestone triggering the second US$ 250 million near-term contingent payment from Bristol Myers Squibb (BMS). SystImmune was expected to receive the payment shortly. Following this trigger, cumulative upfront and triggered near-term payments under the collaboration would reach US$ 1.3 billion.
• Key Highlights:
• Key details of the payment:
  • Current Trigger: US$250 million associated with a milestone in IZABRIGHT-Lung02; receipt was described as forthcoming.
  • Prior Payments: US$800 million upfront received on March 7, 2024; a first US$250 million near-term contingent payment was triggered in September 2025 by a pivotal breast-cancer program milestone.
  • Remaining Potential: Up to US$7.1 billion in additional development, regulatory and sales payments, subject to the collaboration’s conditions.
• Product Profile – BL-B01D1:
  • BL-B01D1: An EGFR × HER3 bispecific antibody-drug conjugate developed by Biokin Pharmaceutical and SystImmune.
  • Mechanism: Designed to bind EGFR and HER3 on tumor cells and deliver a cytotoxic payload, promoting tumor-cell killing.
  • Indication Focus: Nasopharyngeal carcinoma and esophageal squamous cell carcinoma, with additional development in lung, breast and other solid tumors.
  • Development Stage: Approved in China in June 2026 for later-line recurrent or metastatic nasopharyngeal carcinoma and in July 2026 for second-line advanced esophageal squamous cell carcinoma; multiple global Phase III studies are ongoing.

Clinical

Hansoh’s (3692.HK) TYK2 Inhibitor HS-10374 Meets Phase III Co-Primary Endpoints in Plaque Psoriasis, with NDA Preparation Planned

Key Words: Hansoh Pharmaceutical, HS-10374, TYK2, plaque psoriasis, Phase III, PASI 75, sPGA, NDA

• The News: Hansoh Pharmaceutical announced that its oral selective allosteric TYK2 inhibitor HS-10374 met both co-primary endpoints and multiple secondary endpoints in a pivotal Phase III trial in adults with moderate-to-severe plaque psoriasis. At Week 16, response rates for PASI 75 and sPGA 0/1 with at least a two-point improvement from baseline were reported to be significantly higher than with placebo. Hansoh plans to initiate regulatory discussions and prepare a new drug application.
• Key Highlights:
• Pivotal Phase III results:
  • Design: Randomized, double-blind, placebo-controlled, multicenter study with 503 enrolled participants.
  • Co-Primary Endpoints: PASI 75, defined as at least a 75% reduction from baseline in Psoriasis Area and Severity Index, and sPGA 0/1 with at least a two-point improvement, both assessed at Week 16.
  • Secondary Responses: More than half of treated patients achieved PASI 90 and nearly one-third achieved PASI 100 at Week 16; exact rates were not provided.
  • Safety: The company reported tolerability consistent with the TYK2 inhibitor class and no new safety signal.
• Product Profile – HS-10374:
  • HS-10374: An oral, highly selective allosteric TYK2 inhibitor independently developed by Hansoh Pharmaceutical.
  • Mechanism: Inhibits TYK2-mediated signaling downstream of IL-12, IL-23 and type I interferons, modulating immune pathways implicated in autoimmune disease.
  • Indication Focus: Moderate-to-severe plaque psoriasis, with additional clinical studies in psoriatic arthritis and alopecia areata.
  • Development Stage: Met co-primary endpoints in a pivotal Phase III plaque psoriasis trial; regulatory discussions and NDA preparation are planned.

RemeGen (688331.SH) Registers Phase III Study of RC148 Plus Chemotherapy Versus Tislelizumab in First-Line Nonsquamous NSCLC

Key Words: RemeGen, RC148, PD-1, VEGF, bispecific antibody, nonsquamous NSCLC, Phase III, tislelizumab

• The News: A trial registry update reported on September 21 describes a new Phase III study comparing RemeGen’s PD-1 × VEGF bispecific antibody RC148 plus platinum-based chemotherapy with tislelizumab plus platinum-based chemotherapy in previously untreated advanced nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. The randomized, double-blind, multicenter trial will assess progression-free survival (PFS) by a blinded independent radiology review committee under RECIST v1.1 as its primary endpoint.
• Key Highlights:
• Phase III study:
  • Population: First-line advanced nonsquamous NSCLC without actionable genomic alterations.
  • Comparator: Tislelizumab plus platinum-based chemotherapy.
  • Primary Endpoint: Independently assessed PFS under RECIST v1.1.
• Earlier Phase II findings presented at WCLC:
  • Data Cutoff: June 22, 2026; enrollment included 61 squamous and 60 nonsquamous NSCLC patients.
  • Nonsquamous Cohort: At 12.3 months’median follow-up, the 10 mg/kg group had an ORR of 76%, confirmed ORR of 72.4% and median PFS of 11.1 months. Median duration of response was immature and median OS was not reached.
  • Subgroups: In PD-L1-negative patients, ORR was 71.4% and confirmed ORR 64.3%. In patients aged at least 65 years, the respective rates were 100% and 92.9%; these descriptive subgroup results do not establish an age-independent treatment effect.
• Product Profile – RC148:
  • RC148: An investigational PD-1 × VEGF bispecific antibody developed by RemeGen and partnered with AbbVie.
  • Mechanism: Designed to combine PD-1 checkpoint blockade with VEGF targeting, supporting antitumor immune activity while inhibiting tumor-associated angiogenesis.
  • Indication Focus: Advanced squamous and nonsquamous non-small cell lung cancer.
  • Development Stage: In Phase III development, including a newly registered first-line nonsquamous NSCLC study comparing RC148 plus chemotherapy with tislelizumab plus chemotherapy.

IASO206 Shows Preliminary Activity Without Lymphodepletion in First-in-Human In Vivo BCMA CAR-T Study

Key Words: IASO Biotherapeutics, IASO206, BCMA, in vivo CAR-T, multiple myeloma, Phase I, IIT, IMS 2026

• The News: On September 26 at IMS 2026, IASO Biotherapeutics presented first-in-human Phase I investigator-initiated trial results for IASO206, an intravenously administered in vivo BCMA CAR-T therapy for relapsed or refractory multiple myeloma. Ten patients received treatment without lymphodepleting chemotherapy, and nine achieved a response. The approach is intended to generate CAR-T cells within the patient following a single infusion, avoiding apheresis and ex vivo cell manufacturing.
• Key Highlights:
• Study population and cellular kinetics:
  • Patients: Ten treated patients; median three prior treatment lines, range 2- Seventy percent were triple-class exposed, 90% had high-risk cytogenetics and 70% had ultra-high-risk features.
  • Dose Levels: 1×10⁸, 3×10⁸ and 9×10⁸ transducing units.
  • Expansion: CAR-positive cells expanded in all patients, with peaks on Days 12–23; vector copy number peaked on Days 12- CAR-positive cells remained detectable during follow-up extending to six months.
• Preliminary efficacy:
  • ORR: 90% (9/10); three patients achieved stringent complete response.
  • MRD: Overall minimal residual disease negativity was 90%. The highest-dose cohort had 100% ORR and MRD negativity, although its denominator was not provided in the report.
  • Response Depth: The one MRD-positive patient in the lowest-dose cohort achieved a very good partial response.
• Safety:
  • DLT and Neurotoxicity: No dose-limiting toxicity, ICANS or treatment-related deaths were reported.
  • CRS: Two patients had no cytokine release syndrome, seven had Grade 1 and one had Grade 2; median duration was 2.5 days.
  • Other Events: Grade 3 or higher hematologic adverse events occurred. Two Grade 3 or higher viral infections resolved with treatment. Cross-trial safety superiority over conventional CAR-T has not been established.
• Product Profile – IASO206:
  • IASO206: An investigational, intravenously administered in vivo BCMA CAR-T therapy developed by IASO Biotherapeutics.
  • Mechanism: Designed to generate BCMA-directed CAR-T cells within the patient following infusion, enabling T-cell recognition and killing of BCMA-expressing malignant cells.
  • Indication Focus: Relapsed or refractory multiple myeloma.
  • Development Stage: In a first-in-human Phase I investigator-initiated trial, with preliminary results from 10 treated patients presented at IMS 2026.
• IASO Biotherapeutics: A China-based biotechnology company focused on developing and commercializing innovative cell therapies and biologics for hematologic malignancies and autoimmune diseases.

InnoCare (688428.SH) Launches Phase III Mesutoclax–Azacitidine Study Against Venetoclax–Azacitidine in Newly Diagnosed AML

Key Words: InnoCare, mesutoclax, ICP-248, BCL-2, azacitidine, venetoclax, AML, Phase III

• The News: A CDE trial-platform update reported on September 23 describes InnoCare’s third Phase III study of mesutoclax (ICP-248), a BCL-2 inhibitor. The randomized, open-label trial plans to enroll 318 older or intensive-chemotherapy-ineligible patients with newly diagnosed acute myeloid leukemia (AML). It will compare mesutoclax plus azacitidine with venetoclax plus azacitidine, using overall survival as the primary endpoint.
• Key Highlights:
• Phase III design:
  • Planned Enrolment: 318 patients.
  • Treatment Arms: Mesutoclax plus azacitidine versus venetoclax plus azacitidine.
  • Primary Endpoint: Overall survival.
• Earlier Phase I ICP-CL-01205 results:
  • Response: Composite complete remission (CR + CRi) was 81.8%; MRD negativity was reported at 86.5%, with the evaluable denominator not specified in the report.
  • Time to Response: Eighty-three percent of patients achieving complete remission did so in the first treatment cycle.
  • 125 mg Cohort: The six-month duration-of-response rate was 93.3% and the six-month OS rate was 90.5%.
  • TP53-Mutated AML: Composite complete remission was 71.4%, with a six-month duration-of-response rate above 50%.
• Product Profile – Mesutoclax (ICP-248):
  • ICP-248: An oral, selective BCL-2 inhibitor developed by InnoCare Pharma.
  • Mechanism: Selectively inhibits the anti-apoptotic protein BCL-2, restoring apoptosis in cancer cells dependent on BCL-2 signaling for survival.
  • Indication Focus: Acute myeloid leukemia, mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma.
  • Development Stage: In Phase III development in AML, MCL and CLL/SLL.

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.

DISCLAIMER

This document is prepared by Selesta Partners Limited (“Selesta”) for information purposes only.  Neither Selesta nor the Directors of the company accept any responsibility whatsoever for the accuracy or completeness of the information provided by third parties contained in this document. It should not be copied or distributed to third parties without the written consent of Selesta.

The views expressed (if any) are the views of Selesta only and are subject to change based on market and other conditions. The information provided does not constitute investment advice and it should not be relied on as such. All material has been obtained from sources believed to be reliable at the date of presentation, but its accuracy is not guaranteed. This material contains certain statements that may be deemed forward-looking statements. Please note that any such statements are not guarantees of any future performance and actual results or developments may differ materially from those projected.

The information contained herein does not constitute an offer to sell or an invitation to buy any securities in any jurisdiction in which such distribution or offer is not authorized to any person. No part of this document, or any information contained herein, may be distributed, reproduced, taken or transmitted into jurisdiction or territories/ possession in which such activities are not permitted. Any failure to comply with the restrictions may constitute a violation of the relevant laws.

This document does not constitute a prospectus, an offer or an invitation to subscribe to any securities, or a recommendation in relation to any securities.

Investors should note investment involves risk and past performance is not indicative of future results.

© 2026 Selesta