Onconic Therapeutics Secures U.S. Patent for Nesuparib Crystalline Form and Manufacturing Method
核心洞察
Onconic Therapeutics (搜索) has received a U.S. patent registration decision covering a novel high-purity, high-stability crystalline form and manufacturing method for its anticancer candidate nesuparib, valid through May 2042.
The new patent extends intellectual property protection beyond the existing compound patent (expiring 2036) to the crystal structure and production process critical for regulatory approval and commercial manufacturing.
Nesuparib is a dual-target synthetic lethal agent inhibiting both tankyrase (搜索) and PARP (搜索), currently in Phase 2 trials across pancreatic, ovarian, endometrial, and gastric cancers.
Onconic Therapeutics (搜索) (476060.KQ) has secured a U.S. patent covering the manufacturing technology for its anticancer drug candidate nesuparib, extending its intellectual property rights beyond the existing compound patent to the crystal structure and production method used in actual drug manufacturing. The company announced on August 31 that it had completed payment of U.S. patent registration fees for a new crystal structure and manufacturing method for nesuparib, with final issuance procedures—including assignment of a patent number by the U.S. Patent and Trademark Office (USPTO)—currently under way.
The patent protects a crystal structure that allows nesuparib to be produced with high purity and high stability, along with the method for manufacturing it. Even with identical ingredients, the way molecules are arranged in the solid state can affect a drug substance's stability, quality consistency, and reproducibility in mass production. This is a critical factor not only in clinical development but also in regulatory approval and commercial manufacturing.
Expanding the U.S. Patent Portfolio
The addition of a manufacturing-related patent to the existing nesuparib compound patent, which runs through 2036, expands the company's U.S. patent portfolio. The new patent runs through May 2042. The technology has been filed in more than 30 countries including the United States, and registration has been completed in South Korea, Japan, Australia, Saudi Arabia, and Chile, among others.
"Commercializing a new drug requires not only clinical development but also manufacturing processes and secured intellectual property rights," an Onconic Therapeutics (搜索) official said. "Having expanded the scope of manufacturing-related patent protection at the point where we are preparing to enter U.S. Phase 2 trials, we will continue global development and commercialization preparations for nesuparib."
A representative from Onconic Therapeutics (搜索) further noted, "Through the new drug approval and commercialization process of Jakubo, we confirmed the importance of CMC capabilities and securing intellectual property rights; we have continued to accumulate relevant experience and know-how." The representative added that by applying this experience to nesuparib, the company has expanded its scope of patent protection just as it prepares to enter Phase 2 clinical trials in the U.S.
Mechanism of Action and Clinical Development
Nesuparib is a dual-target anticancer drug candidate that simultaneously inhibits tankyrase (搜索), which is involved in cancer cell growth, and PARP (搜索), an enzyme that helps repair damaged DNA. It uses a synthetic lethality mechanism that blocks two pathways cancer cells depend on for survival. The drug is currently in Phase 2 trials across four cancer types: pancreatic, ovarian, endometrial, and gastric cancer (搜索).
Combination therapies are also in development. The company is evaluating treatment efficacy in trials administering nesuparib alongside MSD's immuno-oncology drug Keytruda (pembrolizumab) and Celltrion's bevacizumab biosimilar Vegzelma.
U.S. Regulatory Pathway
U.S. clinical development is in preparation. Nesuparib has received three orphan drug designations from the U.S. Food and Drug Administration (FDA), covering pancreatic cancer (搜索), gastric and gastroesophageal junction cancer, and small cell lung cancer (搜索). Onconic Therapeutics (搜索) is holding pre-IND meetings with the FDA, targeting submission of a U.S. Phase 2 investigational new drug (IND) application by the end of this year.