On January 13, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported an update on the Company’s 2026 strategic priorities and clinical development progress. These updates will be discussed as part of the Company’s presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026, at 3:00 p.m. PT / 6:00 p.m. ET.

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"Since our founding, we have intentionally built Zai Lab as a dual-engine company – combining a commercially profitable and scaling China business with a global innovation engine that is now reaching a pivotal inflection point," said Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "With Zoci now in Phase 3 and multiple global programs advancing behind it, we are entering our next phase with a highly efficient, globally integrated R&D platform, a strong balance sheet, and the capabilities to execute at scale."

"Our regional business is built around a portfolio of high-impact, first- and best-in-class medicines that are driving durable, multi-year growth," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "This engine provides a strong and growing financial foundation to support our long-term strategic priorities. At the same time, our dual-gateway model and partner-of-choice position enable us to consistently access high-quality innovation and advance those assets efficiently on a global stage."

Zai Lab’s Dual-Engine Strategy

Zai Lab’s differentiated dual-engine model is designed to drive both near-term performance and long-term global value creation. The Company’s commercially profitable and scaling China business provides a strong financial foundation to invest in global innovation. Its fully integrated cross-border R&D platform enables faster, more capital-efficient development of high-quality assets, as demonstrated by Zoci’s rapid advancement from first-in-human studies to global pivotal trials. Together, these two engines uniquely position Zai Lab to build a globally competitive biopharmaceutical company.

Advancing Differentiated Global Programs Across Oncology and Immunology

Zocilurtatug Pelitecan (Zoci or ZL-1310)

Zoci, the Company’s lead global asset and a potential first- and best-in-class DLL3-targeting ADC, is expected to be in three registrational studies by the end of 2026:

2L/3L SCLC (small cell lung cancer): Data demonstrated a 68% overall response rate (ORR) with a favorable safety profile, including low rates of Grade 3+ adverse events and no treatment-related discontinuations at 1.6 mg/kg. A registrational Phase 3 study has been initiated.
1L SCLC: An ongoing Phase 1 combination study with PD-L1 ± chemotherapy is expected to inform the design of a Phase 3 study anticipated to initiate by year-end. A novel combination Phase 1 study is expected to initiate in the first half of 2026.
NEC (neuroendocrine carcinoma): A Phase 1 study is ongoing, with results expected in the first half of 2026. A registration-enabling study is expected to initiate in the second half of 2026.
Other Global Oncology Assets

ZL-6201: A novel LRRC15-targeting ADC designed to disrupt the tumor microenvironment by targeting tumor-associated fibroblasts (TAF), enabling potential for broad applicability across multiple solid tumors (sarcoma, breast cancer, NSCLC). Global Phase 1 initiation is expected in 1Q 2026.
ZL-1222: A next-generation PD-1/IL-12 immunocytokine that has demonstrated strong anti-tumor activity in preclinical models, including in PD-1-sensitive and resistant settings, with an improved systemic safety profile. IND-enabling studies are expected to complete this year.
ZL-1311: A next-generation T-cell engager (TCE) targeting MUC17, a promising and druggable antigen overexpressed in up to ~50% of gastric and gastroesophageal junction cancers. The program represents Zai Lab’s first globally owned TCE and strategically expands our immuno-oncology portfolio while leveraging our established expertise in GI cancers. ZL-1311 is expected to enter global clinical development this year.
Zai Lab is building capabilities in TCEs and exploring additional immunocytokines beyond IL-12, with further details to be provided throughout the year.

ZL-1503: A Novel Dual-Targeting Approach for Atopic Dermatitis (AD)

ZL-1503 is a first-in-class bispecific antibody dual-targeting IL-13 and IL-31R designed to provide rapid itch relief and broad disease control.

The Company anticipates reporting First-in-Human (FIH) data from healthy volunteers in the second half of 2026, paving the way for Phase 2 development in AD patients.
Key Near-Term Regional Launches to Drive Steady Growth

Today, Zai Lab has eight commercial products in China, forming a diversified and durable commercial portfolio. COBENFY is expected to launch in the first half of 2026 through a focused, high-impact commercial strategy, emphasizing physician education, real-world evidence generation, and preparation for potential NRDL inclusion in 2027. Additional near-term launches, including povetacicept and VRDN-003, are expected to add further layers of growth to the regional business. As China’s regulatory and market access environment continues to evolve, Zai Lab is well positioned to deliver long-term growth.

Catalyst-Rich 2026: Granular Milestones to De-Risk Pipeline and Drive Value

2026 is expected to be a defining year for Zai Lab, with multiple high-impact milestones across its global pipeline. Key catalysts include the continued execution of Zoci’s pivotal program, the advancement of multiple novel oncology and immunology assets into the clinic, several anticipated IND filings, and data readouts designed to further validate the Company’s integrated R&D platform. On the regional front, the expected launch of COBENFY and continued growth of existing product franchises are expected to further strengthen the Company’s financial foundation. Together, these milestones are expected to continue to de-risk the pipeline, accelerate value inflection points, and support Zai Lab’s next phase of global growth.

(Press release, Zai Laboratory, JAN 13, 2026, View Source [SID1234662032])

On January 12, 2026 ConcertAI, a leading oncology real-world evidence data and AI SaaS technology company, and Foundation Medicine, a global, patient-focused precision medicine company, reported a collaboration to combine their data assets for life sciences research. The collaboration brings Foundation Medicine’s expansive de-identified multimodal dataset derived from its genomic testing portfolio together with ConcertAI’s high-quality clinical data, to support more efficient drug development and real-world evidence research. With the addition of Foundation Medicine’s data, ConcertAI now offers the largest and most comprehensive clinically-linked dataset with nearly half a million patients.

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The collaboration comes as oncology drug programs face rising trial complexity and tighter budgets, which puts more weight on high-quality data that can guide early decisions. Pairing Foundation Medicine and ConcertAI’s data captures the full journey of cancer patients from pre-diagnosis through treatment and outcomes, allowing life science researchers and biopharmaceutical developers to reduce guesswork in early research, tighten trial plans, and bring new therapies to patients faster, while ensuring the rigor of their research.

"Drug developers are increasingly pushed to accelerate their research pipelines but require more robust insights into both early genomic signals and patient outcomes to make this a reality," said Eron Kelly, CEO of ConcertAI. "By combining the largest and deepest set of clinical data with genomic insights, including whole slide imaging, we can help teams set a clearer plan and speed up their projects. Our collaboration with Foundation Medicine complements our full suite of partnerships aimed at advancing the development of vital therapies."

Foundation Medicine has U.S Food and Drug Administration-approved companion diagnostic indications for all four major classes of genomic alterations and for multiple genomic signatures. Detection of these major classes of alterations provide partners with a comprehensive view of their cohort’s genomic landscape, including difficult-to-detect alterations, such as MTAP loss, that are not detected well by all next-generation sequencing tests.1

In addition to genomic data, the combined dataset includes gene expression data, immunohistochemistry (IHC) results, and whole-slide images, alongside one of the most diverse clinical datasets from ConcertAI, whether measured by socioeconomic diversity, ethnic diversity, or rural vs. urban communities. By connecting these views, researchers can better study how cancers act in real life and how patients respond to treatments over time.

"By integrating our high-quality genomic data with ConcertAl’s electronic health data, we have created one of the most powerful new real-world data sets that enables insights to be turned into strategic decisions at critical milestones for our partners," said Dan Malarek, CEO of Foundation Medicine. "AI is the future and through our Al-driven analytical capabilities via FoundationInsights, our biopharmaceutical and research partners can access the right data when they need it and uncover answers faster. This accelerates development and helps patients benefit sooner from advances in precision medicine."

(Press release, Foundation Medicine, JAN 12, 2026, View Source [SID1234662000])

On January 12, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech") and OncoC4, Inc. ("OncoC4") reported that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to gotistobart (also known as BNT316 or ONC-392) for the treatment of squamous NSCLC, an aggressive subtype of lung cancer with limited therapeutic options in the advanced stage. The FDA grants Orphan Drug Designation to potential new medicines for prevention, diagnosis, or treatment of patients with either a rare disease, or a specific patient population with a non-rare disease. This designation underscores the urgent medical need for new therapeutic options for patients living with this condition.

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Gotistobart is a novel tumor microenvironment-selective regulatory T cell ("Treg") depletion candidate targeting CTLA-4. With its unique mode of action, gotistobart has the potential to address the high unmet medical need in patients with squamous NSCLC, which accounts for around 25% of all lung cancer cases1 and high disease-related mortality2. Squamous NSCLC is a devastating disease with a 5-year relative survival rate of 15%, a median survival time of 11 months in the United States (2000-2017)3, and with limited treatment options in the advanced stage. For advanced or metastatic squamous NSCLC patients, the treatment options for second-line therapy after first-line immunotherapy and chemotherapy are usually limited to chemotherapy or palliative therapy.4

The pivotal Phase 3 clinical trial PRESERVE-003 (NCT05671510; EUCT:2023-505311-20-01) is ongoing, evaluating gotistobart in patients with metastatic squamous NSCLC at 160 sites globally. In a data readout from the non-pivotal dose-confirmation stage of the trial, gotistobart demonstrated a clinically meaningful overall survival ("OS") benefit, compared to standard-of-care chemotherapy and a manageable safety profile in squamous NSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. These data were previously announced and presented in an oral presentation at the IASLC ASCO (Free ASCO Whitepaper) 2025 North America Conference on Lung Cancer. In addition to the recently granted Orphan Drug Designation, the FDA granted Fast Track Designation to gotistobart in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy.

About gotistobart (BNT316/ONC-392)
Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective Treg depletion candidate developed jointly by BioNTech and OncoC4. As a pH-sensitive monoclonal antibody, gotistobart is designed to enable CTLA-4 protein recycling. After binding to the CTLA-4 receptor on the cell surface, the complex is internalized, and the pH change causes the antibody to unbind, allowing CTLA-4 to return to the surface to preserve the immune checkpoint function at peripheral organs and to enhance anti-tumor immunity in the tumor microenvironment5. Gotistobart is currently in late-stage clinical development as monotherapy and as a component of combination therapy in various cancer indications. Gotistobart received Fast Track Designation from the U.S. Food and Drug Administration ("FDA") in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy and Breakthrough Therapy Designation from China’s National Medical Products Administration ("NMPA") in 2025.

About PRESERVE-003 Trial
PRESERVE-003 (NCT05671510; EUCT:2023-505311-20-01) is a two-stage, open-label Phase 3 trial evaluating the efficacy and safety of gotistobart as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in sqNSCLC patients, who have progressed on PD-(L)1 inhibitors and platinum-based chemotherapy. The non-pivotal stage of the trial originally included all NSCLC patients. The ongoing pivotal stage is currently enrolling patients with squamous NSCLC. During the ongoing pivotal stage, patients are planned to be enrolled at 160 clinical sites in various countries and regions, including Australia, Belgium, Canada, China, Germany, Italy, the Netherlands, Spain, South Korea, Türkiye, the United Kingdom and the United States. The primary endpoint is overall survival. Secondary endpoints include overall response rate, progression-free survival and safety profile.

(Press release, BioNTech, JAN 12, 2026, View Source [SID1234661940])

On January 12, 2026 Leapfrog Bio, a clinical-stage precision oncology company dedicated to discovering and developing novel targeted therapies for cancers caused by loss-of-function (LOF) mutations, reported the publication of a peer‑reviewed study in npj Systems Biology and Applications, a Nature Portfolio journal, titled "Challenges and opportunities for oncology drug repurposing informed by synthetic lethality." The paper provides a practical framework for drug retargeting in oncology and highlights core discoveries that helped guide the optimization of Leapfrog Bio’s OncoSLX Platform.

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"This paper validates two fundamental realities in targeted cancer drug discovery: genetic targeting opportunities discovered in cell lines are more likely to hold up in the clinic when caused by a driver mutation, and drugs behave very differently from genetic knockouts, so screening them against the causal biology is essential," said Tomas Babak, Ph.D., Founder and Chief Scientific Officer of Leapfrog Bio and co-author on the publication. "Our OncoSLX platform is built on these principles and allows us to run thousands of these drug-mutation tests against all cancer driver mutations simultaneously, quickly identifying potent, genetically targeted treatments for LOF cancers."

Dr. Babak continued, "By screening clinically safe drugs, we can restart development in Phase 2 in genetically selected patients where the probability of efficacy is higher. We expect this approach to be significantly accelerating and derisking as we advance through development."

"Leapfrog Bio was founded to bring the transformative benefit of precision medicines to the many patients with cancers caused by LOF mutations, for whom targeted options are limited," said Greg Vontz, Chief Executive Officer of Leapfrog Bio. "Among our most promising discoveries to date is the vulnerability of EP300 LOF cancers to BET inhibitors, like our lead candidate, LFB190. Leveraging learnings from our OncoSLX platform, we are positioned to advance LFB190 directly into mid-stage development. We look forward to initiating our planned Phase 1b/2a trial in mid-2026."

LFB190 is an oral, small-molecule, potentially best-in-class BETi in development for the more than 60,000 U.S. patients annually who are diagnosed with EP300-mutated solid tumors, including non-small cell lung, bladder, colon, pancreatic, head and neck, and bile duct cancers. While BET inhibitors have been widely studied across cancer indications, they have shown limited efficacy in genetically unselected populations. Extensive preclinical studies have shown that BET inhibitors can be highly effective when used to treat EP300-driven cancers, and previous clinical development of LFB190 as an untargeted therapy has shown favorable safety and tolerability for the drug.

About OncoSLX Platform
OncoSLX Platform is Leapfrog Bio’s proprietary pharmacogenetic platform that screens clinically characterized small molecules against isogenic models of cancer driver mutations, focusing on loss‑of‑function biology. Unlike traditional synthetic‑lethality approaches based on gene knockouts, OncoSLX captures the full spectrum of drug biology and then integrates real‑world outcomes data to prioritize indications likely to deliver survival benefit, compressing timelines and reducing translational risk. This approach identifies novel treatments for loss-of-function-driven cancers that cannot be discovered by conventional methods.

About LFB190 and EP300-Mutated Cancers
LFB190 is a novel, oral BET inhibitor for the treatment of solid tumors driven by EP300 loss-of-function (LOF) mutations. Leapfrog Bio’s OncoSLX Platform has identified a novel synthetic lethality relationship between BET inhibitors and EP300 LOF mutations, which are a known and frequent cancer driver with no targeted therapy available. LFB190 has shown strong preclinical efficacy in patient-derived xenograft (PDX) models of EP300-mutated cancers. EP300 is a tumor suppressor gene involved in chromatin remodeling and transcriptional regulation. When mutated, its loss contributes to tumor progression across multiple cancer types, including approximately 6 percent of non-small cell lung cancers (NSCLC), approximately 15 percent of bladder cancers, and similar frequencies in colon, pancreatic, and head and neck cancers. While BET inhibitors have historically shown limited efficacy in unselected populations, Leapfrog Bio’s platform revealed a compelling effect in EP300-mutated tumors.

(Press release, Leapfrog Bio, JAN 12, 2026, View Source [SID1234661957])

On January 12, 2026 Tahoe Therapeutics and Alloy Therapeutics reported that they are forming a jointly seeded new company focused on developing first-in-class antibody-drug conjugates (ADCs) for patients with hard-to-treat cancers.

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The joint venture will advance two ADC programs directed at novel tumor targets discovered by Tahoe using its proprietary Mosaic platform and large-scale, perturbative single-cell datasets. The collaboration reflects a strong strategic fit between Tahoe’s ability to identify high-confidence, tumor-selective targets using its AI-powered virtual cell models and Alloy’s end-to-end capabilities in biologic drug engineering, ADC design, and company creation through its venture studio 82VS.

Over the past year, Tahoe analyzed a subset of its proprietary multi-million-cell datasets and identified tens of tumor-specific surface antigens, many of which had taken decades to discover previously, and most of which are novel. Tahoe subsequently validated the most promising targets across multiple independent assays and clinical samples. After rigorous evaluation, Alloy recognized the exceptional therapeutic potential of these targets, catalyzing the decision to jointly spin out a dedicated ADC development company around two of them.

"We are excited to partner with Tahoe and were immediately impressed by the depth and quality of biological insight generated by the Mosaic platform," said Errik Anderson, Founder and CEO of Alloy Therapeutics. "With our track record of 20 clinical programs discovered with Alloy platforms and services, including multiple drugs in Phase III, we are well positioned to translate the cutting-edge biology from world-class target rich companies like Tahoe into optimized therapeutics."

Under the structure of the joint venture, Tahoe and Alloy will co-invest, co-build, and co-lead the new company. Tahoe will contribute its novel targets and biomarker insights, while Alloy will provide its ADC engineering platforms, translational development expertise, and 82VS company creation infrastructure. Together, the team aims to efficiently advance both ADC programs to key value-inflection points suitable for independent financing or pharma partnerships.

Our datasets and AI models are enabling the discovery of novel targets," said Nima Alidoust, co-founder and CEO of Tahoe Therapeutics. "Alloy, which has had a strong track record in developing first-in-class biologics, shares this excitement with us, and that is a strong validation of the biology discovered by our platform. This joint venture is also a preview of the business model our platform enables: building new companies alongside partners with complementary capabilities."

Combining Tahoe’s AI-powered approach to understanding novel tumor biology with Alloy’s fully integrated drug discovery, development, and company creation capabilities creates a highly efficient path to translate novel biologic insights into first-in-class drugs for patients in need.

(Press release, Alloy Therapeutics, JAN 12, 2026, View Source [SID1234661974])