Shanghai Henlius Biotech Secures Exclusive Rights to Convalife Pharmaceuticals’ Generic Neratinib in China

SHANGHAI—Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. The deal grants Henlius the exclusive commercialization rights to Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional licensing rights for overseas markets and regions. The financial details of the agreement have not been disclosed.

Neratinib, an oral irreversible small molecule pan-HER tyrosine kinase inhibitor (TKI), is a significant advancement in the treatment of breast cancer. It works by irreversibly blocking the downstream signaling pathways of HER2 and estrogen receptor (ER), effectively inhibiting tumor cell proliferation and growth. The generic neratinib product received approval in China in June of this year and is indicated as an enhanced adjuvant therapy for adult patients with HER2 positive early breast cancer who have completed adjuvant therapy with trastuzumab.

Henlius plans to further explore the potential of neratinib in combination with its own biosimilar product, Hanquyou (trastuzumab; HLX02), a biosimilar version of Roche’s Herceptin. This combination therapy aims to reduce the recurrence risk in HER2 positive early breast cancer patients at the 5-year and 10-year milestones post-surgery.

The strategic licensing deal not only expands Henlius Biotech’s portfolio in oncology but also signifies the company’s commitment to improving treatment outcomes for breast cancer patients in China and potentially other regions through innovative drug therapies.- Flcube.com

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