InnoPharmax announced on November 11 that it has officially submitted an application to the U.S. FDA to begin a Phase III clinical trial for its oral gemcitabine soft capsule, D07001, as a treatment for bile duct cancer. If the FDA does not provide feedback within the 30-day review period, the trial will proceed.
Wei-Hua Hao, CEO of InnoPharmax, stated that this Phase III clinical trial is a global, multi-center, double-blind, randomized, placebo-controlled study. Following feedback from a Type C consultation meeting with the FDA mid-year and a pre-review of the trial synopsis, the FDA approved the design with some modifications. The trial will enroll 195 bile duct cancer patients in third-line treatment or those unwilling to undergo second-line intravenous chemotherapy. The company is also preparing a study protocol for pancreatic cancer and plans to apply for a Phase III trial for that indication next year.
InnoPharmax recently completed a cash capital increase, issuing 12.5 million shares and raising NT$225 million to fund the clinical development of D07001. Additionally, following last year’s approval of its generic drug, sapropterin hydrochloride tablets, the company received regulatory approval in July for its gadopentetate dimeglumine injection, an imaging agent, from China’s National Medical Products Administration (NMPA).
According to Hao, InnoPharmax collaborated with Shandong New Era Pharmaceutical to develop the imaging agent, with InnoPharmax supplying the raw materials and Shandong New Era focusing on formulation. With regulatory approval obtained, InnoPharmax will receive milestone payments and has already begun shipping raw materials, with formal sales planned for the gadopentetate dimeglumine injection (GDDM). Meanwhile, the approval process for the GTM formulation of gadopentetate dimeglumine injection is nearing completion.
D07001 represents an innovative adaptation of gemcitabine, originally available only as an injectable, into an oral soft capsule based on metronomic dosing principles. This approach not only delivers cytotoxic effects but also provides immune modulation and inhibits tumor angiogenesis, differentiating it from traditional high-dose chemotherapy. The low-dose, high-frequency dosing schedule aims to minimize systemic toxicity while maintaining therapeutic efficacy.
By reducing chemotherapy’s overall toxicity, D07001 allows patients to maintain a higher quality of life during treatment. Given the aggressive nature of bile duct cancer, patients often face a dual burden from the disease and the side effects of chemotherapy. D07001, with its unique therapeutic foundation, holds promise as a novel paradigm for chemotherapy in bile duct cancer and potentially other cancers.
Resource (mandarin): 搶攻膽管癌治療商機 因華D07001新藥三期臨床計畫正式啟動
