On January 6, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that China’s National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for AUGTYRO (repotrectinib) for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The approval is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options.

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"We are pleased with the NMPA’s approval of AUGTYRO for patients with NTRK-positive solid tumors. This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population," said Dr. Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "We believe this approval will help address the high unmet medical needs for patients across this treatment spectrum."

The NMPA’s decision is based on the results from the pivotal Phase 1/2 TRIDENT-1 study, which demonstrated robust and durable efficacy and a manageable safety profile of repotrectinib in patients with NTRK fusion-positive solid tumors. Zai Lab contributed to the global pivotal TRIDENT-1 study and dosed the first patient in Greater China in May 2021.

In May 2024, the NMPA approved AUGTYRO (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Zai Lab has an exclusive license agreement with Bristol Myers Squibb Co., following their acquisition of Turning Point Therapeutics, Inc., to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively).

About AUGTYRO

AUGTYRO (repotrectinib) is a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 and NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of these drugs to their target. Ultimately, this leads to a shortened duration of response and tumor progression. Repotrectinib is the first next-generation ROS1 and NTRK TKI uniquely designed to improve durability of benefit, including in the brain, and to address acquired resistance.

In June 2024, AUGTYRO (repotrectinib) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

In May 2024, AUGTYRO was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. It was approved by the FDA for this indication in November 2023.

About NTRK-Positive Solid Tumors

NTRK-positive advanced solid tumors are life-threatening with poor prognoses and represent an area of significant unmet medical need in adult and pediatric patients. Existing targeted therapies have demonstrated clinical benefits but are limited by the duration of response due to the emergence of acquired resistance mutations.1 In China, the NMPA’s approval is the first to span both TRK TKI-naïve and TRK TKI-pretreated patients across solid tumors.

(Press release, Zai Laboratory, JAN 6, 2026, View Source [SID1234661787])

On January 6, 2026 NanOlogy, LLC, a clinical-stage oncology company, reported the appointment of John M. Goldberg, MD as fractional Chief Medical Officer (CMO) to advance development of its Large Surface Area Microparticle (LSAM) drug portfolio including its development program targeting Diffuse Intrinsic Pontine Glioma (DIPG), a devastating pediatric brain cancer with limited treatment options.

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John is a graduate of the University of Massachusetts Chan Medical School and is board-certified in Pediatric Hematology/Oncology, with more than 20 years of experience in all phases of drug development, from early research through late-phase clinical trials. His most recent roles as CMO included positions at Rafael Holding, Inc., a healthcare investment, family office, and biotechnology company, and at Oncorus, Inc., a biopharmaceutical company developing an intratumorally delivered viral immunotherapy for cancer. Earlier in his career, John served as Senior Medical Director at H3 Biomedicine Inc. (a research subsidiary of Eisai) and Medical Director at Agenus, Inc., and was also a Lecturer part-time at Harvard Medical School and Associate Professor at the University of Miami Miller School of Medicine.

"As we progress our DIPG program toward initiating a clinical trial in late 2026 and advance our clinical-stage investigational drugs into late-phase clinical trials, John will play a critical role in our development strategy and execution," said David Arthur, CEO of Nanology. "John’s broad expertise across both drug development and business strategy will strengthen our ability to rapidly advance these programs."
"I am impressed by NanOlogy’s progress and believe my experience, including development of intratumoral therapies, positions me well to contribute to NanOlogy’s future success," said John Goldberg, MD. "My initial priorities are to advance the DIPG program and select the best clinical pathway for our adult solid tumor investigational drugs. I am looking forward to our progress and the benefit it may hold for cancer patients."

(Press release, NanOlogy, JAN 6, 2026, View Source;utm_medium=rss&utm_campaign=nanology-appoints-john-m-goldberg-md-as-chief-medical-officer-to-further-its-preclinical-clinical-large-surface-area-microparticle-investigational-drug-portfolio [SID1234661756])

On January 6, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12-15, 2026, in San Francisco, Calif. As a global leader in life sciences, Astellas will use this premier platform to highlight its key strategic focuses and the tangible progress achieved to date in support of delivering long-term impact for patients, partners, and shareholders.

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During the conference, President and CEO Naoki Okamura will present Astellas’ key growth drivers and commitment to disciplined execution. Chief Research & Development Officer Tadaaki Taniguchi will also join the session, and together, they will emphasize how Astellas is advancing transformative scientific breakthroughs for diseases with high unmet medical need and reinforcing its leadership in healthcare innovation and shaping the future of patient care.

Naoki Okamura, President and CEO, Astellas
"Our focus is clear: we are working to turn innovative science into meaningful VALUE for patients and drive sustainable growth. The J.P. Morgan Healthcare Conference provides an exceptional opportunity to engage with the global investment and healthcare community and demonstrate how our strategy and execution position Astellas for long-term success."

Presentation Details

Event: 44th Annual J.P. Morgan Healthcare Conference
Date & Time: January 12, 2026, at 3:00 p.m. PT
Location: Westin St. Francis, San Francisco
The presentation materials and a live webcast link will be available on the Investor Relations page of Astellas.com on the day of the presentation. A link to the on-demand replay will be made available shortly after the presentation.

As a distinguished sponsor of Biotech Showcase held in San Francisco the same week, Astellas is furthering its visibility in the global life sciences community. Chief Strategy Officer Adam Pearson will join a plenary session on partnering trends that are advancing emerging technologies and drug development innovation—underscoring Astellas’ commitment to pioneering science and fostering collaborations to benefit patients worldwide.

(Press release, Astellas Pharma, JAN 6, 2026, View Source [SID1234661772])

On January 6, 2026 OncoNano Medicine, Inc. ("OncoNano") reported a research collaboration with Gilead Sciences, Inc. (Nasdaq: GILD) ("Gilead") to evaluate OncoNano’s ON-BOARD encapsulation technology with Gilead’s drug candidate.

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Under the terms of the agreement, OncoNano and Gilead will collaborate to evaluate the stability, selectivity and efficacy of Gilead’s drug candidate encapsulated by OncoNano’s ON-BOARD technology.

"Partnering with Gilead underscores the broad applicability of our ON-BOARD platform," said Kartik Krishnan, MD, PhD, CEO of OncoNano Medicine. "Our platform is designed to localize drug delivery into tumors with high spatial and temporal specificity. We believe it can complement Gilead’s oncology expertise to bring effective treatment options to patients."

Under the terms of the agreement, OncoNano will receive an upfront payment and is eligible to receive additional near-term preclinical milestones. OncoNano is also eligible to receive development, regulatory and commercial milestones, and royalties on net sales for the encapsulated asset. Gilead has the option to expand the collaboration by nominating an additional target for the ON-BOARD technology, in which case OncoNano would be eligible to receive up to an aggregate of $300 million, comprising the upfront payment and milestone payments, plus royalties.

(Press release, OncoNano Medicine, JAN 6, 2026, View Source [SID1234661788])

On January 6, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that its novel next-generation BTK-targeted protein degrader, APG-3288, has received the IND clearance from the U.S. Food and Drug Administration (FDA) and is poised to enter a clinical study in patients with relapsed/refractory B-cell malignancies. This clearance officially opens the chapter on Ascentage Pharma’s clinical development in the field of targeted degradation and marks another major expansion to the company’s global innovative pipeline.

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This is a global, multicenter, open-label Phase I study designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies.

BTK is a key kinase in the B-cell receptor (BCR) signaling pathway and plays a central role in the activation, proliferation, and survival of B-cells. Aberrant BTK activation is closely associated with the initiation and progression of multiple B-cell malignancies such as B-cell lymphoma (including diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma), chronic lymphocytic leukemia (CLL), and Waldenström’s macroglobulinemia (WM)1. Beyond oncology indications, BTK also plays a critical role in both BCR- and Fc receptor-mediated signal transduction in innate immune cells. As a result, the aberrant activation of BTK has been implicated in the pathogenesis of various autoimmune and inflammatory diseases2. BTK inhibitors have drastically improved treatment outcomes for patients with B-cell malignancies. However, BTK mutations and remodeling of signaling pathways often lead to acquired resistance during prolonged treatment. There remains an urgent clinical need for new drugs promising novel mechanisms of action.

APG-3288 is the first novel, highly potent and selective BTK degrader developed utilizing Ascentage Pharma’s proprietary proteolysis-targeting chimera (PROTAC) technology platform. This candidate induces the formation of a ternary complex consisting of the BTK target, the PROTAC, and the Cereblon E3 ubiquitin ligase, leading to proteasome-mediated degradation of the BTK target. Unlike conventional BTK inhibitors, APG-3288 is designed to act through degradation rather than inhibition, inducing rapid, potent, highly selective, and sustained degradation of both wild-type BTK and multiple BTK mutants associated with resistance to existing BTK inhibitors. Critically, this approach blocks the BCR-BTK signaling axis at its source, thereby overcoming resistance to BTK inhibitors and potentially providing a novel and differentiated therapeutic strategy for BTK-targeted treatment4.

In preclinical studies, compared to other BTK degraders in development, APG-3288 demonstrated more potent BTK degradation, higher selectivity, and more favorable PK properties that highlighted the drug’s potential.

(Press release, Ascentage Pharma, JAN 6, 2026, View Source [SID1234663142])