/TRANSTHERA-B - VOLUNTARY ANNOUNCEMENT MARKETING APPROVAL FOR YOCHANRA (TINENGOTINIB TABLETS) GRANTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
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TRANSTHERA-B - VOLUNTARY ANNOUNCEMENT MARKETING APPROVAL FOR YOCHANRA (TINENGOTINIB TABLETS) GRANTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

HKEXnews
2026/08/06[Other - Business Update]

TRANSTHERA-B - VOLUNTARY ANNOUNCEMENT

MARKETING APPROVAL FOR YOCHANRA (TINENGOTINIB TABLETS) GRANTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

TransThera Sciences (Nanjing), Inc.

藥捷安康(南京)科技股份有限公司 (A joint stock company incorporated in the People's Republic of China with limited liability) (Stock Code: 2617)

VOLUNTARY ANNOUNCEMENT

MARKETING APPROVAL FOR YOCHANRA® (TINENGOTINIB TABLETS) GRANTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

This announcement is made by TransThera Sciences (Nanjing), Inc. (the "Company", together

with its subsidiaries, the "Group") on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business advancement of the Group.

The board of directors (the "Board") of the Company announces that, Yochanra® (Tinengotinib tablets), a Class 1 new drug self-developed by the Company, obtained conditional marketing approval from the National Medical Products Administration ("NMPA") for the treatment of adult patients with unresectable advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor (FGFR)2 fusion or rearrangement, who have received prior systemic therapy and FGFR inhibitor treatment. Previously, this therapy was included in the List of Products for Priority Review and was granted Breakthrough Therapy Designation by the NMPA.

The conditional marketing approval of Yochanra® by the NMPA was based on a multicenter, open-label, single-arm, pivotal Phase II clinical trial conducted in China. The study data showed

that as of 27 December 2025, median follow-up time was 12 months. Among 50 patients with advanced CCA, all patients had at least one line of chemotherapy, and one prior FGFR inhibitor treatment. According to the blinded independent central review (BICR) assessment:

• The objective response rate (ORR) was 28.0% with 14 confirmed partial responses, and median duration of response (DoR) was 8.5 (95% CI: 5.6~12.5) months. The disease control rate (DCR) was 82.0%.

• The median progression free survival (mPFS) was 6.0 (95% CI: 4.4~8.3) months.

• The median overall survival (mOS) was 20.7 (95% CI: 11.8~ -) months.

About CCA

The global CCA drug market size reached USD2.0 billion in 2024 and is expected to grow to USD3.2 billion in 2027, of which approximately 25.2% of CCA patients have FGFR alterations. According to a research paper published in Cancer Treat Reviews in 2023, CCA patients will develop acquired resistance after receiving FGFR inhibitor treatment, and FGFR-mutated CCA patients who have developed drug resistance have faced a dilemma of having no available drugs in the past.

About Yochanra®

Yochanra® is an internally discovered, innovative multi-kinase small molecule inhibitor of the Company targeting FGFR, JAK, VEGFR and Aurora, which exerts antitumor effects by precision targeting, lineage reprogramming and immune activation. Ongoing clinical trials conducted globally have revealed the potential of Yochanra® to be efficacious in various solid tumors such

as CCA, prostate cancer, breast cancer and liver cancer. Yochanra® has been granted Orphan Drug Designation (ODD) and Fast Track Designation by the U.S. FDA for the treatment of CCA, and Orphan Drug Designation (ODD) by the EMA for the treatment of biliary tract cancer.

This approval marks the first indication approved for Yochanra® in the PRC. Currently, a randomized, controlled, open-label, multi-center Phase III clinical confirmatory study is being conducted in the PRC to verify its efficacy and safety versus chemotherapy in patients with unresectable advanced or metastatic intrahepatic CCA harboring FGFR2 fusion/rearrangement or mutation, who have relapsed or progressed following first-line systemic therapy in the prior treatment. The marketing and application of Yochanra® are expected to benefit patients with CCA who have received prior systemic therapy and FGFR inhibitors, and fill the guideline gap in third-line treatment for advanced CCA. Meanwhile, the Company will continue to advance the exploration of Yochanra® in other indications to provide clinical treatment options for a wider

range of patients.

Warning under Rule 18A.08(3) of the Listing Rules: There is no assurance that the relevant products will ultimately be successfully developed and marketed by the Company.

By order of the Board TransThera Sciences (Nanjing), Inc. 藥捷安康(南京)科技股份有限公司 Dr. Frank Wu Chairman and Chief Executive Officer

Hong Kong, 6 August 2026