On September 1, 2025 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that the United States Adopted Names (USAN) Council has adopted the name narmafotinib as the generic drug name for the Company’s lead FAK inhibitor currently undergoing clinical studies in pancreatic cancer (Press release, Amplia Therapeutics, SEP 1, 2025, View Source [SID1234655616]).

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Amplia has previously reported that the World Health Organization (WHO) approved narmafotinib as the International Non-Proprietary Name (INN) for global use1. The USAN council’s adoption of the name narmafotinib is a separate process that formalises the nonproprietary name for the molecule in the United States.

Dr Chris Burns, Amplia’s CEO and Managing Director commented: "We are delighted that the USAN council have adopted the name narmafotinib. Obtaining a USAN is an essential step for any drug molecule intended for the US market, and it represents an important step in the drug’s commercial development as we begin our trial of narmafotinib in the USA."

On September 1, 2025 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, reported that the transaction announced last August 25th has now been completed with €500k in cash received by the Company August 28th (Press release, TME Pharma, SEP 1, 2025, View Source [SID1234655614]). The cash position of TME Pharma is up to €2.35M, showing the good progress of the new cost-efficient organization.

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Now that TME Pharma has implemented the lower cost-base model, it will be more able to attract partners for the development of new therapies for cancer and eye diseases. TME Pharma still has high expectations for its NOX-A12 and NOX-E36 programs. TME Pharma will keep informing the markets about the progress it is making.

CEO Van den Ouden will continue to use his experience and expertise to implement the Company’s treasury investment strategy to properly balance risk and return to achieve optimal results for shareholders. TME Pharma is continuing to search for suitable crypto and crypto related candidates for the treasury investment strategy but has no current exposure to crypto.

On September 1, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy (Press release, Zai Laboratory, SEP 1, 2025, View Source [SID1234655613]).

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"Today’s approval of TIVDAK marks an important milestone for Zai Lab, further strengthening our Women’s franchise in Greater China," said Andrew Zhu, Chief Commercial Officer, Greater China, Zai Lab. "Treatment options for patients with recurrent or metastatic cervical cancer after initial therapy are limited. TIVDAK, the first antibody-drug conjugate (ADC) therapy in cervical cancer, delivers a clinically meaningful survival benefit to patients. With our established commercial infrastructure for ZEJULA in Hong Kong, we are uniquely positioned to ensure TIVDAK reaches patients without delay."

TIVDAK is currently under regulatory review for its Biologics License Application by China’s National Medical Products Administration (NMPA), which was accepted in March 2025.

About TIVDAK (tisotumab vedotin-tftv)

TIVDAK (tisotumab vedotin) is an 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 U.S. Food and Drug Administration (FDA) in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).