On June 8, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial, which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy, including in an exploratory subpopulation of patients in China.

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The NMPA approval follows regulatory approvals in the United States, Japan, European Union, United Kingdom, Macau (China), and Hong Kong (China), underscoring the broad global clinical evidence supporting TIVDAK availability in China. The indication statement for TIVDAK differs slightly by region.

"Cervical cancer remains one of the leading causes of cancer death in women in China. Antibody-drug conjugates have proven to be novel and effective treatments for many types of cancer, and we are pleased to bring this innovative therapeutic class to patients in China with cervical cancer," said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. "Coupled with the previous global approvals of TIVDAK for this disease, the China BLA approval further validates the robust global evidence of clinical benefit for this population of advanced patients with limited therapeutic options."

Results from the Phase 3 innovaTV 301 clinical trial, including data from the China subpopulation of this study that Zai Lab conducted, supported global approval of TIVDAK:

In the global study, the trial met its primary endpoint of OS in the intention-to-treat (ITT) population of the global study (HR=0.70; 95% CI: 0.54–0.89; two-sided p=0.0038). The China subpopulation showed consistent results, with a clinically meaningful improvement in OS (HR: 0.55, 95% CI: 0.27- 1.15), corresponding to a 45% reduction in the risk of death compared to chemotherapy.1
54.1% of the China subpopulation received prior anti-PD(L)1 therapy, the current standard of care for second-line treatment of cervical cancer. TIVDAK showed consistent OS benefit trends irrespective of prior immunotherapy exposure.2
There were no new safety signals identified among patients in the China subpopulation who received TIVDAK. The most common Grade ≥3 treatment-emergent adverse events (TEAEs) in the global study were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%).1 The most common Grade ≥3 TEAEs in the China subpopulation were anemia (11.4%), cough (5.7%), and malaise (5.7%).2
"Treatment options are very limited for cervical cancer patients once recurrence or metastasis occurs," said Dr. Lingying Wu, Ph.D., China Leading Principal Investigator of the innovaTV 301 Study and Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. "Consistent with findings from the global innovaTV 301 trial, the China subpopulation data demonstrate that TIVDAK offers significant clinical benefits to these patients, irrespective of prior PD-(L)1 inhibitor therapy."

Zai Lab will leverage the company’s extensive experience and expanding presence in the Chinese gynecologic oncology community, as well as commercial synergies with its ZEJULA team, to bring TIVDAK to patients in China.

About Cervical Cancer in China

An estimated 150,000 new cases of cervical cancer occur annually in China3. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients.

About Tisotumab Vedotin

Tisotumab vedotin (approved under the brand name TIVDAK in the EU, U.K., U.S. and Japan) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

TIVDAK received full approval from the U.S. Food and Drug Administration in April 2024, and U.S. approval was first secured in September 2021 under the accelerated approval pathway for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval has also been received in Japan, European Union, Macau (China), and Hong Kong (China) for the same indication.

Zai Lab has an exclusive license from Seagen Inc., a company later acquired by Pfizer, for TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). Zai Lab is solely responsible for the development, supply, and commercialization of TIVDAK in Greater China.

(Press release, Zai Laboratory, JUN 8, 2026, View Source [SID1234666493])

On June 8, 2026 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI/ML, reported that management will participate in Jones Trading’s Mapping the Path from Target to Patient: Fireside Chat Series with Leaders in AI/ ML-based Drug Development on Monday, June 15, 2026, from 10:30-11:00 AM ET.

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A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

(Press release, Compugen, JUN 8, 2026, View Source [SID1234666492])

On June 8, 2026 Hengrui Pharma reported more than 90 studies spanning multiple tumor types and therapeutic modalities at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting was held in Chicago from May 29 to June 2 (local time). As one of the world’s leading oncology conferences, the ASCO (Free ASCO Whitepaper) Annual Meeting serves as a key venue for presenting advances in cancer research and clinical development..

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According to statistics, 94 Chinese research projects were selected for oral presentations at ASCO (Free ASCO Whitepaper) this year, including 12 late-breaking abstracts, marking the third consecutive year of growth. At 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, Hengrui Pharma presented 91 accepted studies and 11 oral presentations featuring innovative therapies, underscoring the breadth of the company’s oncology pipeline and ongoing investment in innovative drug development.

As a leading innovative pharmaceutical company in China, Hengrui continues to focus on oncology research and drug development. For 16 consecutive years, Hengrui has shared data from its oncology portfolio at the ASCO (Free ASCO Whitepaper) Annual Meeting. This year, the company’s research program encompasses multiple key areas, including gastrointestinal cancers, breast cancer, lung cancer, urological cancers, gynecological cancers, and supportive cancer care, covering 11 approved medicines, 10 pipeline candidates, and one Class 2 new drug (NMPA classification).

Breast Cancer: New Data Support Multiple Emerging Treatment Strategies

For triple-negative breast cancer, the HELEN-Trio 011 study led by Professor Zhenzhen Liu of Henan Cancer Hospital showed that the pathological complete response (pCR) rate for neoadjuvant therapy with camrelizumab combined with chemotherapy reached 57.5%, significantly outperforming the pCR of 45.4% observed with chemotherapy alone. In the field of neoadjuvant therapy for HER2-positive early breast cancer, the HELEN HER-013 study was the first to demonstrate that the chemotherapy-de-escalated regimen of nanoparticle albumin-bound paclitaxel, trastuzumab, and the tyrosine kinase inhibitor pyrotinib (nab-PHPy) is noninferior to standard TCHP, offering a new treatment option for patients who cannot tolerate severe hematologic toxicity.

Gastrointestinal Cancers: ADC and Immunotherapy Combination Treatments Show Promise

In the field of colorectal cancer, the HORIZON-CRC01 study led by Professor Jin Li of Shanghai GoBroad Cancer Hospital Affiliated to China Pharmaceutical University and Professor Ying Yuan of The Second Affiliated Hospital of Zhejiang University School of Medicine demonstrated that the new-generation anti-HER2 ADC, trastuzumab rezetecan, when used to treat patients with HER2-positive, RAS and RAF wild-type advanced colorectal cancer who have progressed after standard second-line therapy, achieved a median progression-free survival (PFS) of 5.5 months, compared to 2.8 months with standard-of-care (SOC), suggesting a potential new treatment option for patients whose disease has progressed following standard therapies. In the field of hepatocellular carcinoma, the phase III CARES-336 trial, led by Academician Jia Fan (Zhongshan Hospital, Fudan University) and Professor Shukui Qin (Tsientang Institute for Advanced Study)—demonstrated that the combination of camrelizumab plus rivoceranib with transarterial chemoembolization (TACE) significantly improved median progression-free survival (PFS) versus TACE alone (11.1 vs. 8.3 months; BICR-assessed per mRECIST).This triplet regimen represents a new benchmark for systemic-combined locoregional therapy for patients with unresectable HCC (uHCC).

Urological Cancers: Dual Breakthroughs in Prostate and Bladder Cancers

The FUZUPRO study, led by Professor Dingwei Ye of Fudan University Shanghai Cancer Center, demonstrated that first-line treatment with fluzoparib combined with abiraterone acetate and prednisone for metastatic castration-resistant prostate cancer (mCRPC) resulted in a median radiographic PFS of 24.8 months, compared to 19.9 months with the standard regimen. Another study demonstrated that the anti-Nectin-4 ADC SHR-A2102 combined with adebrelimab achieved a pCR of 48.1% and a pathological downstaging rate of 59.3% in the perioperative treatment of muscle-invasive bladder cancer, including those with renal dysfunction.

Supportive Cancer Care: Additional Evidence for New Antiemetic Drug

The Phase III PROTECT study, led by Professor Li Zhang and Professor Yuhong Li of the Sun Yat-sen University Cancer Center, demonstrated that Fosrolapitant and Palonosetron Hydrochloride for Injection—a novel, ultra-long-acting antiemetic developed in-house by Hengrui—achieved significantly higher complete response rates than the standard regimen during the acute, delayed, and overall phases for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy. These findings add to the growing body of clinical evidence supporting its use in supportive cancer care.

Hengrui Pharma currently markets 16 approved oncology medicines in China and is advancing nearly 60 oncology candidates across its research portfolio. The company is conducting more than 150 clinical trials worldwide across its key oncology development programs.

Hengrui’s expanding presence at the ASCO (Free ASCO Whitepaper) Annual Meeting reflects continued progress across its oncology pipeline and broader clinical development efforts. The company’s research presentations this year span multiple tumor types and therapeutic modalities, highlighting both approved medicines and investigational candidates across its oncology portfolio.

As oncology research continues to evolve globally, Hengrui remains focused on translating scientific innovation into potential clinical benefit for patients through sustained investment in research and development.

(Press release, Hengrui Pharmaceuticals, JUN 8, 2026, View Source [SID1234666491])

On June 8, 2026 Kali Therapeutics, a clinical-stage biotechnology company pioneering next-generation immune-resetting and multi-specific therapies, reported that preclinical data for KT209, its novel trispecific antibody candidate, will be presented in a poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) (EHA 2026) Annual Congress.

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KT209 is a novel trispecific antibody engineered to co-engage CD19, CD20, and CD3, redirecting endogenous T cells to achieve deep B-cell depletion. While traditional bispecific T-cell engagers (TCEs) targeting a single antigen face challenges with treatment failure due to antigen escape (low or lost CD19/CD20 expression), KT209’s dual-antigen targeting mechanism is designed to prevent escape and improve clinical outcomes. Enhanced by a proprietary CD3 masking design, KT209 delivers exceptional anti-tumor potency alongside a highly optimized safety profile.

Presentation Details

Poster Title: A NOVEL TRISPECIFIC ANTIBODY KT209 TARGETING CD19, CD20, AND CD3 (CD19XCD20XCD3) DEMONSTRATED POTENT ACTIVITY IN B-CELL DISEASES WITH LOWER CYTOKINE RELEASES
Poster Number: PF369
Session: Poster Session 1
Dates: Thursday, June 11 – Friday, June 12, 2026
Highly Differentiated Preclinical Profile

The upcoming poster presentation highlights comprehensive preclinical data evaluating KT209 across in vitro, in vivo, and non-human primate (NHP) models:

Resistance-Proof Cytotoxicity: KT209 demonstrated robust clearance against both Raji and Nalm19 leukemia cells. Crucially, in Nalm19 models—which express low levels of CD20—the approved TCE glofitamab suffered a significant drop-off in efficacy, whereas KT209 maintained potent tumor-killing activity.
Decoupling Potency from Toxicity: In head-to-head human PBMC assays, KT209 demonstrated a clear trend of lower inflammatory cytokine release compared to glofitamab, successfully mitigating the primary driver of Cytokine Release Syndrome (CRS).
In Vivo Tumor Clearance: In humanized NOG mouse models, KT209 achieved potent, dose-dependent anti-leukemia activity.
Favorable NHP Safety and Tolerability: In non-human primates, a single subcutaneous dose of KT209 triggered rapid and deep peripheral B-cell depletion at the lowest tested dose. The molecule was completely well-tolerated with zero clinical adverse events and only minimal, transient cytokine release restricted to the first dose.
Leadership Commentary

John Wang, Chief Scientific Officer of Kali Therapeutics, commented:

"The data to be showcased at EHA (Free EHA Whitepaper) underscores the highly differentiated profile of KT209. By integrating dual-antigen B-cell targeting with our proprietary CD3 masking technology, we have engineered a molecule that is fundamentally more potent than currently approved TCEs in low-antigen environments, yet operates with a much wider safety window. This allows us to achieve maximum tumor attrition while strictly limiting systemic cytokine release."

Weihao Xu, Chief Executive Officer of Kali Therapeutics, stated:

"Our presentation at EHA (Free EHA Whitepaper) 2026 marks a pivotal milestone in the strategic expansion of Kali. By bringing our platform into the oncology space, we are demonstrating that our ability to safely engage T-cells is truly drug-class agnostic. The unique safety profile of our TCEs, which has already validated our autoimmune pipeline, allows us to aggressively target hematologic malignancies where tumor escape and severe CRS have historically limited patient outcomes. With KT209, we look forward to advancing into first-in-human clinical trials in Q1 2027."

About KT209

KT209 is a novel CD19 x CD20 x CD3 trispecific antibody engineered using Kali’s proprietary multi-specific antibody platform. It is designed to maximize therapeutic efficacy by simultaneously binding to two distinct B-cell antigens (CD19 and CD20) and co-engaging CD3 on T cells. This dual-targeting approach minimizes the risk of tumor escape while its unique CD3 masking design controls T-cell activation kinetics, reducing cytokine release syndrome (CRS) risks while enabling complete removal of pathogenic B-cell populations.

(Press release, Kali Therapeutics, JUN 8, 2026, View Source [SID1234666490])

On June 8, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical-stage oncology company advancing a three-platform pipeline in RNA therapeutics and immuno-oncology, reported it will host its first live virtual R&D Webcast on Thursday, June 18, 2026, at 10:00 a.m. Eastern Time.

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The webcast will provide strategic, scientific, and clinical program updates anchored by TransCode’s recently-initiated Phase 2a clinical trial of TTX-MC138 — the Company’s lead antagomiR program — in ctDNA-positive colorectal cancer, alongside portfolio and investment thesis updates across its development pipeline. A recording of the webcast will be made available on the Company’s website following the event.

Date:

Thursday, June 18, 2026

Time:

10:00 -11:15 a.m. Eastern Time

Format:

Live webcast, open access

Registration:

Will be made available on www.transcodetherapeutics.com as of June 11, 2026

Replay:

Webcast recording available on the Company’s website following the event

The webcast will cover:

TTX-MC138 Phase 2a clinical development, including trial design and strategic path forward
Pipeline and development strategy across the Company’s other candidates and platforms
Capital strategy, financial position, and long-term investment thesis
Featured speakers will include:

Guest: Keith Flaherty, MD — Director of Clinical Research, Massachusetts General Hospital Cancer Center; Professor of Medicine, Harvard Medical School; Member, TransCode Scientific Advisory Board
Philippe P Calais, PharmD, PhD — Chief Executive Officer and Chairman of the Board, TransCode Therapeutics
Dan Vlock, MD — Consulting Oncology Clinician, TransCode Therapeutics
Zdravka Medarova, PhD — Co-Founder and Chief Scientific Officer, TransCode Therapeutics
Louis Brenner, MD — Consulting Strategic Advisor, TransCode Therapeutics
Michel Janicot, PhD — Consulting Head of Translational Science, TransCode Therapeutics
"With TTX-MC138 now beginning enrollment in Phase 2a, and with two additional platform assets advancing on capital-disciplined timelines, TransCode is at a meaningful inflection point. This webcast is an opportunity to share for the first time in our Company’s history the scientific depth behind our programs, review the clinical data that supported our decision to move into the Phase 2a trial, and articulate the investment thesis underlying a three-platform pipeline. We look forward to engaging with our investors and the investment community."

(Press release, TransCode Therapeutics, JUN 8, 2026, View Source [SID1234666489])