On January 18, 2026 D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications:

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D3S‑003 — a KRAS G12D inhibitor — enabling the start of a Phase 1 first‑in‑human clinical trial.
A Phase 2 combination trial evaluating D3S‑001 (elisrasib), the Company’s next‑generation KRAS G12C inhibitor, in combination with D3S‑002, a selective oral ERK1/2 inhibitor.
D3S‑003 is an orally bioavailable, allele‑specific KRAS G12D inhibitor that targets both the GDP‑bound (OFF) and GTP‑bound (ON) conformations. Preclinical data demonstrate a differentiated, best‑in‑class profile with potent anti‑tumor activity, favorable drug‑like characteristics, and a promising safety margin. With FDA clearance received, D3 Bio will advance D3S‑003 into a Phase 1 first‑in‑human study in patients with advanced solid tumors harboring KRAS G12D mutations.

The newly cleared Phase 2 study will evaluate the combination of D3S‑001 and D3S‑002 in patients with KRAS G12C–mutant non‑small cell lung cancer (NSCLC) who have progressed on prior KRAS G12C‑targeted therapies. The trial, expected to begin in the first half of 2026, will investigate safety, pharmacokinetics, and early efficacy signals with the goal of establishing a rational combination strategy to address resistance and deliver more durable benefit in KRAS‑driven cancers.

"We are excited to receive FDA IND clearance for D3S‑003 and to advance a Phase 2 combination clinical trial of elisrasib and D3S‑002," said George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. "With D3S‑003, we are bringing a differentiated KRAS G12D inhibitor into the clinic to address one of the most prevalent and challenging KRAS mutations. In parallel, the combination study of elisrasib and D3S‑002 pushes forward our next‑generation KRAS G12C strategy, particularly for patients who have progressed on prior KRAS G12C‑targeted therapies. Together, these milestones underline the momentum of our KRAS franchise and reinforce our commitment to delivering transformative therapies for patients with KRAS‑mutant cancers who urgently need new options."

About Elisrasib (D3S-001)

Elisrasib is a next‑generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP‑bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

Key publications:

Cancer Discovery (2024) 14(9):1675–1698
Nature Medicine (2025) 31(8):2768–2777
About D3S‑002

D3S‑002 is a selective ERK1/2 inhibitor strategically designed for combination approaches, providing vertical MAPK‑pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.

Key publication:

Cancer Res 1 April 2023; 83 (7_Supplement): 5501.
About D3S‑003

D3S‑003 is a differentiated KRAS G12D inhibitor targeting both OFF and ON conformations to address one of the most common KRAS mutations. The program aims to broaden D3 Bio’s multi‑allele KRAS franchise and deliver new solutions for the heterogeneous and evolving landscape of KRAS‑driven cancers.

(Press release, D3 Bio, JAN 18, 2026, View Source [SID1234662080])

On January 16, 2026, Terns Pharmaceuticals, Inc. (the "Company") and its subsidiaries reported to have entered into an Amendment (the "Amendment") to its existing Exclusive Option and License Agreement with Hansoh (Shanghai) Healthtech Co., Ltd. and certain of its affiliates (collectively, "Hansoh"), dated July 27, 2020 (the "Option and License Agreement"). Under the Option and License Agreement, Hansoh had previously obtained from the Company an exclusive, sub-licensable and royalty-bearing license under certain patent and other intellectual property rights owned or controlled by the Company to research, develop, manufacture, use, distribute, sell and otherwise exploit therapeutic products containing TERN-701 in the field of oncology in mainland China, Taiwan, Hong Kong and Macau (the "Hansoh Territory").

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Under the Amendment, Hansoh granted the Company an exclusive, royalty-bearing, sublicensable, perpetual, and worldwide (excluding the Hansoh Territory) license, under certain patents and patent applications that were invented by Hansoh and its affiliate Shanghai Hansoh Biomedical Co., Ltd. during its activities under the Option and License Agreement (the "Exclusively Licensed Hansoh Patents"), to research, develop, manufacture, use, distribute, sell and otherwise exploit therapeutic products containing TERN-701 as the sole active ingredient ("701 Products"). This exclusive, sub-licensable and royalty-bearing license replaces a non-exclusive, non-sublicensable (without Hansoh’s consent), royalty-free, fully paid license to the Exclusively Licensed Hansoh Patents that Hansoh had previously granted to CaspianTern, LLC, a subsidiary of the Company, under the Option and License Agreement. Under the terms of the Amendment, the Company is obligated to pay Hansoh a one-time upfront license fee of $1.0 million and tiered royalties ranging from 0.75% to 1.25% on annual net sales of 701 Products in countries in the Company’s territory to the extent the sale of 701 Products is covered by a valid claim of an Exclusively Licensed Hansoh Patent, subject to specified reductions.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ended Marrch 31, 2026.

(Filing, 8-K, , JAN 16, 2026, View Source [SID1234662170])

On January 16, 2026, Exicure, Inc. (the "Company") reported the first contractual milestone under its License and Collaboration Agreement (the "Agreement") with GPCR Therapeutics Inc. The milestone relates to the completion of the Company’s Phase 2 clinical trial of its novel stem cell mobilizer (NCT05561751), which was achieved through the formal submission of the Clinical Study Report to the U.S. Food and Drug Administration on January 16, 2026. Under the terms of the Agreement, the Company is required to make a milestone payment of $1,000,000 to GPCR Therapeutics Inc. within 30 days of achieving this milestone. The Company intends to make this payment in accordance with the terms of the Agreement.

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The Company believes that achieving this milestone reflects continued progress in the development and advancement of the small molecule CXCR4 inhibitor, Burixafor (GPC‑100). In addition, under the terms of the Agreement, completion of this milestone triggers the future sublicensing income‑sharing ratio, reflecting the Company’s increased participation in and commitment to the long‑term success of the program.

(Press release, Exicure, JAN 16, 2026, View Source [SID1234662165])

On January 16, 2026 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported that its Shareholders (as defined below) have approved the acquisition of all of the issued and outstanding common shares of the Company (the "Common Shares" and the holders of the Common Shares, the "Shareholders") by XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly "Xeno") a non-profit biotechnology company, by way of a statutory plan of arrangement (the "Transaction" or the "Arrangement") at the special meeting of Shareholders held today (the "Meeting").

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The special resolution approving the Arrangement was approved by: (i) 99.76% of the votes cast by Shareholders present in person or represented by proxy at the Meeting, and (ii) 99.76% of the votes cast by Shareholders, present in person or represented by proxy at the Meeting, excluding for this purpose the votes required to be excluded pursuant to Multilateral Instrument 61- 101 Protection of Minority Security Holders in Special Transactions.

At the Meeting, Shareholders also approved: (a) on an advisory and non-binding basis, the compensation to be paid or become payable to the Company’s named executive officers that is based on or otherwise relates to the Arrangement by 99.34% of the votes cast by Shareholders present in person or represented by proxy at the Meeting; and (b) in the event the Arrangement is terminated, (i) the voluntary liquidation and dissolution of the Company by 99.75% of the votes cast by Shareholders present in person or represented by proxy at the Meeting and (ii) the appointment of KPMG LLP or, in the alternative, another liquidator of nationally recognized experience, as the liquidator of the Company with authorization for the board of directors of the Company to set the remuneration of the liquidator by 99.75% of the votes cast by Shareholders present in person or represented by proxy at the Meeting.

The Arrangement is subject to the approval of the Superior Court of Québec (the "Court") and other customary closing conditions. The Court hearing for the final order to approve the Arrangement is expected to take place on January 23, 2026 and, assuming receipt of the approval of the Court and satisfaction of other customary conditions to closing, the completion of the Arrangement is expected to occur on or about January 28, 2026.

(Press release, Repare Therapeutics, JAN 16, 2026, View Source [SID1234662076])

On January 16, 2026 Dr. Jason Zhu, Executive Director and Chief Executive Officer of Shanghai Henlius Biotech, Inc. (2696.HK), delivered a keynote presentation outlining Henlius’ "Globalisation 2.0" strategy, diversified innovation pipeline, and its mid-to-long-term development blueprint. The 44th J.P.Morgan Healthcare Conference (JPMHC) was successfully held in San Francisco, the United States, from January 12 to 15. As one of the most influential annual events in the global healthcare sector, JPM serves as a key platform for the capital markets and industry leaders to observe emerging trends in pharmaceutical innovation and industry development. The conference attracted more than 8000 global industry leaders, innovators, entrepreneurs, and investors.

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A Global Biopharmaceutical Vision Toward 2030

Building on its expanding innovation pipeline and accelerating global footprint, Dr. Zhu shared Henlius’ mid-to-long-term vision as a global biopharmaceutical company. To date, Henlius has achieved regulatory approvals for 10 products across 60 markets worldwide, benefiting more than 950,000 patients globally. The Company’s international business continues to grow at a rapid pace. Looking ahead to 2030, Henlius anticipates launching more than 20 products globally, including over 15 products in the U.S. and European markets. The Company will continue to advance innovative modalities such as ADCs, multi-specific antibodies and T-cell engagers (TCEs), covering oncology, autoimmune, metabolic and central nervous system (CNS) diseases. With the continued strengthening of its global commercialisation capabilities, international market revenue is expected to grow further, reinforcing Henlius’ global scale and competitiveness as a global biopharma.

Five Core Capabilities Strengthen the Globalisation Foundation

Dr. Zhu highlighted Henlius’ continuous growth trajectory and phased achievements under its "Globalisation 2.0" strategy:

"With multiple products approved successively in Europe and the United States, and an increasingly mature integrated global operating model, our international business has maintained strong growth momentum. Leveraging our integrated R&D, regulatory and manufacturing capabilities, together with an increasingly mature global clinical and commercialisation network, we have established a systematic capacity to continuously deliver innovative assets worldwide. Over the next five years, stable cash flows from our biosimilar portfolio will further support innovation investment, enabling the advancement of more differentiated molecules, including ADCs, multi-Abs and TCEs, into global markets and building a sustainable, replicable globalisation growth model."

Henlius has established a fully integrated biopharmaceutical platform covering R&D, clinical operations, regulatory affairs, manufacturing and commercialisation. In R&D, the Company has built a diversified pipeline of more than 50 early-stage assets, with approximately 70% classified as best-in-class (BIC) and 15% as first-in-class (FIC). In clinical operations, it operates in-house global clinical teams across China, the United States and other regions, with nearly 600 professionals supporting clinical development in more than 20 countries and over 1000 research centres worldwide, possessing the capability to independently conduct international multicentre clinical trials. In regulatory affairs, the Company has secured a total of 164 IND approvals and 66 New Drug Application (NDA) approvals globally, including 4 Biologics License Application (BLA) approvals from the U.S. FDA, continuously validating its international regulatory and quality management capabilities. In manufacturing and quality, it has completed over 1150 commercial GMP batches, with production facilities certified by regulatory authorities in China, the European Union, the United States and many other countries, providing a strong guarantee for the stable supply of products in the global market. In commercialisation, the company has established a strong oncology-focused commercial team of approximately 1600 professionals in China, while working with more than 20 international commercialisation partners, with its products now marketed in approximately 60 countries and regions.

Core Innovation Assets: Clear 2026 Clinical and Regulatory Milestones

Henlius also outlined clear timelines and development plans for its key innovation assets in 2026:

Serplulimab (trade name: Hetronifly in Europe) – Anti-PD-1 mAb

Approved in over 40 markets globally. By the end of 2026, Henlius expects to achieve:

Accelerated approval for perioperative treatment of gastric cancer in China;
U.S. BLA filings for extensive-stage and limited-stage small cell lung cancer (ES-SCLC and LS-SCLC);
Approval of various indications in the EU;
Completion of enrolment and achievement of primary endpoints in the Japanese bridging study for ES-SCLC.
HLX22 – Novel Epitope Anti-HER2 mAb with a Differentiated Modality

Phase 2 data readout in HER2-low breast cancer in China is expected in the first half of 2026.

HLX43 – PD-L1 ADC ("Pipeline-in-a-Pill") with High-Efficacy, a Favourable Safety Profile and I/O Effects, Potential BIC

By the end of 2026, Henlius anticipates to:

Initiate three global pivotal trials in second-line EGFR wild-type nsqNSCLC, third-line and later sqNSCLC, and second-line sqNSCLC;
Launch two PoC trials in HR-positive and triple-negative breast cancer;
Present clinical data across ESCC, NSCLC, NPC, cervical and ovarian cancers at major congresses (ESCC data were recently presented at ASCO (Free ASCO Whitepaper) GI);
Complete PoC readouts of combination trials with serplulimab ± HLX07 in NSCLC, SCLC and mCRC.
HLX07 – Anti-EGFR mAb with a Dual-Target Synergistic Effect, Expected to Open Up a New First-Line treatment Pathway for EGFR-overexpressing sqNSCLC

Two studies are planned by the end of 2026:

A pivotal Phase 2 trial in cutaneous squamous cell carcinoma;
A global multicentre Phase 2/3 trial in first-line sqNSCLC.
Platform-Driven Innovation Ensures Sustained Output, Building a Next-Generation Pipeline of High-Potential Assets

Henlius’ systematic, platform-based R&D ecosystem continues to generate differentiated innovation candidates. Over the next five years, the Company expects more than 40 new clinical trial applications. At present, the company has established a multi-dimensional innovation platform matrix covering the entire early R&D continuum, from early-stage target screening and validation, to candidate molecule design and optimisation, and through to systematic preclinical development. This integrated platform ecosystem includes a PD-(L)1-centred immune checkpoint inhibitor platform, immune cell engager platforms such as multi-specific T-cell engagers (TCEs), the Hanjugator ADC platform, and the AI-driven one-stop early discovery platform HAI Club. These platforms not only ensure the quality and efficiency of individual R&D programs, but more importantly provide a sustainable, system-level capability to support the development of a globally competitive mid- to long-term innovation pipeline. As a result, the company is able to continuously and efficiently translate cutting-edge scientific discoveries into clinically valuable drug candidates.

Key early-stage assets include:

HLX37: PD-L1 × VEGF bispecific antibody developed based on the immune checkpoint inhibitor platform. It demonstrates high PD-L1 binding affinity and achieves higher tumour microenvironment (TME) enrichment vs. combination therapies, positioning it as a next-generation immunotherapy candidate following serplulimab.
HLX97: Novel oral small-molecule KAT6A/B inhibitor with potential BIC profile, broadly applicable for the treatment of breast cancer, castration-resistant prostate cancer, and NSCLC.
HLX3901: DLL3 × DLL3 × CD3 × CD28 tetravalent TCE developed on the Company’s proprietary TCE platform, featuring longer persistence of activated T cells and greater efficacy in solid tumour treatment.
HLX3902: Potential FIC STEAP1 × CD3 × CD28 trispecific TCE developed on the proprietary TCE platform, demonstrating superior antitumour activity, and increased T-cell infiltration and persistence in TME.
HLX316: Novel potential FIC B7-H3–sialidase fusion protein developed based on Palleon Pharmaceuticals’ EAGLE platform, designed to remove tumour sialic acid to enhance immune response.
HLX48: Safer and more effective cMET x EGFR ADC developed on the Hanjugator ADC platform, designed to maximize antibody function while delivering a stronger bystander effect, for the treatment of NSCLC and colorectal cancer.
HLX49: Potential BIC HER2xHER2 novel bi-paratopic ADC developed on the Hanjugator ADC platform, offering improved efficacy, higher and safer tolerance, and maximized function of antibodies.
At present, the Company’s preclinical asset portfolio spans multiple molecular modalities, including antibodies, multispecific TCEs, ADCs, fusion proteins and small molecules, with a primary focus on solid tumors. Its differentiated development strategy targets both established and emerging targets such as PD-(L)1, DLL3, B7-H3, HER2, EGFR, c-Met and KAT6A/B. The portfolio comprises a balanced mix of potential FIC and BIC candidates, as well as fast-follow programs with higher clinical and commercialisation certainty, laying a solid foundation for the sustained advancement of the mid- to long-term clinical pipeline. By proactively structuring its preclinical portfolio to encompass diverse innovation profiles including FIC, BIC and fast-follow programs, the company has established a tiered R&D architecture that balances frontier innovation with development efficiency and risk management, thereby supporting the continuous progression of its innovation pipeline.

(Press release, Shanghai Henlius Biotech, JAN 16, 2026, View Source;302663316.html [SID1234662075])