On December 18, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track Designation for BGB-B2033, its GPC3x4-1BB bispecific antibody for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment.

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"The FDA awards Fast Track Designation to therapies that show potential to address an unmet medical need in serious or life-threatening conditions. The FDA’s decision reflects the encouraging profile of BGB-B2033 in advanced hepatocellular carcinoma, where patients continue to face limited treatment options," said Julie Lepin, Senior Vice President and Chief Regulatory Affairs Officer at BeOne.

BeOne is currently conducting a global, multi-center Phase 1 clinical trial (NCT06427941) to explore the safety and anti-tumor activity of BGB-B2033, both alone and in combination with PD-1 inhibitor TEVIMBRA (tislelizumab).

About Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) is the sixth most common cancer worldwide and the fourth leading cause of cancer-related death.1 HCC accounts for 80% of all primary liver cancers, with the number of new cases expected to double between 2022 and 2050.2 The rising burden of HCC is primarily attributed to the high prevalence of the hepatitis B and hepatitis C viruses (HBV/HBC) and lifestyle factors such as obesity, tobacco, and alcohol consumption.3 With approximately 80% of patients diagnosed in advanced stages and five-year survival rates for this patient population lower than 20%, new treatment options are needed beyond currently available systemic therapy.

About BGB-B2033

BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in HCC5, and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.6 The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity.

(Press release, BeOne Medicines, DEC 18, 2025, View Source [SID1234661541])

On December 18, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that CEO Uzi Sofer and CFO Raphi Levy will present a corporate overview and update at the J.P. Morgan 2026 Healthcare Conference on Thursday, January 15, 2026 at 11:15am PT / 2:15pm ET, in San Francisco, CA, and will host institutional investor meetings at the event.

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Event: J.P. Morgan 2026 Healthcare Conference
Format: Presentation and 1-on-1 Meetings
Date: January 15, 2026
Time: 11:15AM PT – 11:55AM PT
Location: Westin St. Francis, San Francisco, CA

Webcast: Link will be posted on the "Events & Presentations" page in the Investor Relations section on the Company’s website at View Source

Please reach out to your J.P. Morgan representative to schedule 1-on-1 meetings with Mr. Sofer and Mr. Levy.

(Press release, Alpha Tau Medical, DEC 18, 2025, View Source [SID1234661526])

On December 18, 2025 TransThera Sciences Nanjing, Inc. (the "TransThera") reported that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation ("CDE")of the National Medical Products Administration ("NMPA") of the PRC. It is intended for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib tablets have been included in the List of Products for Priority Review and the List of Breakthrough Therapy Designation for this indication.

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About Tinengotinib

Tinengotinib is an internally discovered, NDA stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials conducted globally have revealed the potential of tinengotinib to be efficacious in various solid tumors, such as cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the European Medicines Agency (EMA), the Priority Review and Approval Procedure and the Breakthrough Therapy Designation (BTD) by the National Medical Products Administration (NMPA) in China for the treatment of CCA.

(Press release, TransThera Biosciences, DEC 18, 2025, View Source [SID1234661542])

On December 18, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech", or "the Company") reported the closing of its acquisition of CureVac N.V. (Nasdaq: CVAC, "CureVac") and that the subsequent offering period (the "Subsequent Offering Period") of the exchange offer (the "Offer") for all outstanding shares of CureVac expired today at 12:01 a.m. Eastern Time.

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As previously published, as of the expiration time of the Subsequent Offering Period, a total of 195,341,219 CureVac shares, collectively representing approximately 86.75% of CureVac’s issued and outstanding shares, were validly tendered in the Offer, of which 11,269,809 CureVac shares were validly tendered in the Subsequent Offering Period. Considering the final exchange ratio of 0.05363 of a BioNTech American Depositary Share ("ADS") per CureVac share as published on November 26, 2025 and the payment of cash in lieu of fractional BioNTech ADSs, in total, 10,475,287 BioNTech ADSs have been, or will be, delivered to tendering holders of CureVac shares, of which 604,201 BioNTech ADSs will be delivered to holders tendering during the Subsequent Offering Period.

(Press release, BioNTech, DEC 18, 2025, View Source [SID1234661527])

On December 18, 2025 Niowave Inc., a U.S.- based global leader in medical radioisotope production, reported the expansion of its existing supply agreement with AstraZeneca, a global biopharmaceutical company, to a 10-year commitment to deliver Actinium-225 (Ac-225), following AstraZeneca’s decision to exercise its option to increase capacity. The agreement secures a reliable and scalable supply of this critical isotope to advance AstraZeneca’s growing portfolio of radioconjugates (RCs). RCs are a type of cancer treatment that use radioactive particles to target and destroy cancer cells.

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"Our expanded agreement with AstraZeneca underscores Niowave’s central role in scaling high-quality production of medical radioisotopes for the development of targeted cancer treatments," said Mike Zamiara, CEO of Niowave. "We are pleased to play a role in ensuring that AstraZeneca’s promising pipeline of radioconjugates have the isotope supply they need."

Ac-225 is one of the most promising radioisotopes in oncology as its emitted alpha particles deliver highly potent, DNA-damaging energy, enabling precise destruction of tumor cells while limiting harm to surrounding healthy tissue with targeted modalities like RCs. Despite its potential, global supply of Ac-225 remains limited. Niowave’s proprietary superconducting linear accelerator technology and radiochemistry provide sustainable, U.S.-based production to address this need.

As AstraZeneca advances RCs for prostate and other difficult-to-treat cancers, the agreement highlights the critical importance of securing dependable isotope supply.

(Press release, AstraZeneca, DEC 18, 2025, View Source [SID1234661543])