TransThera Sciences (Nanjing), Inc. announced that Yochanra® (tinengotinib tablets), its self-developed Class 1 novel kinase inhibitor, has officially entered commercial sales across mainland China following a series of regulatory and supply-chain milestones achieved between August and September 2026.
On 6 August 2026, the National Medical Products Administration granted Yochanra® conditional marketing approval for adult patients with unresectable advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusion or rearrangement who have previously received systemic therapy and an FGFR inhibitor. The drug was subsequently incorporated as a Class II recommendation (Class 2A) in the September 2026 edition of the Chinese Society of Clinical Oncology Guidelines for Biliary Tract Cancers, becoming the first approved therapy in China to address FGFR-altered CCA patients with drug resistance.
Commercial manufacturing started promptly. The inaugural production batch was completed and delivered on 9 September 2026, followed by the initial nationwide shipment on 17 September 2026. The first prescription was issued the same day at Peking University Cancer Hospital. Clinical prescriptions have since extended to hospitals and designated DTP pharmacies in Beijing, Shanghai, Guangdong, Jiangsu and other regions.
Leveraging the distribution network of Sinopharm Holding Jiangsu Co., Ltd., TransThera plans to supply Yochanra® to retail pharmacies across 21 provinces, municipalities and autonomous regions, thereby establishing a full national commercial supply chain.
Tinengotinib targets FGFR, JAK, VEGFR and Aurora kinases, aiming to deliver antitumor activity through precision targeting, lineage reprogramming and immune activation. Beyond its first approved indication in China, the molecule is undergoing global clinical trials for multiple solid tumors, including prostate, breast and liver cancers, and carries Orphan Drug and Fast Track designations from the U.S. FDA as well as Orphan Drug Designation from the European Medicines Agency for biliary tract cancers.
TransThera reiterates that, in line with Hong Kong Listing Rule 18A.08(3), there is no assurance that subsequent clinical indications will ultimately be approved for marketing.
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