Suzhou Terui Pharmaceutical's First-to-File Generic Nilotinib Capsules Approved by China's NMPA on December 30

On December 30, 2022, Teray Pharmaceutical Inc.’s first-to-file generic product, Nilotinib Capsules, was officially approved for marketing by the National Medical Products Administration (Approval Numbers: H20223967 and H20223968). Nilotinib Capsules represent the first drug product to successfully challenge a patent and obtain approval since China implemented the drug patent linkage system.

Nilotinib is a highly selective tyrosine kinase inhibitor (TKI) with antineoplastic activity. As a next-generation TKI, it is effective in the treatment of patients with chronic myeloid leukemia (CML) who are resistant to or intolerant of imatinib. As a second-generation TKI for the treatment of patients with CML in chronic phase (CML-CP), nilotinib demonstrates significantly superior efficacy compared to the first-generation TKI imatinib. It has become a first-line therapy for patients with chronic myeloid leukemia and is also indicated for the treatment of chronic myeloid leukemia in children aged 2 years and older.

The patent for Novartis’ original product is valid until 2030 at the latest. In September 2021, Teray Pharmaceutical Inc. became the first company in China to file a new Class 4 generic drug application for nilotinib capsules and initiate a patent challenge. It was the first company in China to successfully challenge a patent and obtain approval for the first generic version following the implementation of the national drug patent linkage system.

Teray Pharmaceutical Inc., as an R&D-driven pharmaceutical enterprise with a full industrial chain, is committed to improving human health and continuously leverages innovative R&D as the driving force for its development. In recent years, the company has seen a steady stream of new product approvals, with its integrated strategy spanning active pharmaceutical ingredients (APIs) and finished formulations gradually yielding fruitful results.

As of now, Teray Pharmaceutical Inc. has 14 formulation products that have passed or are deemed to have passed the consistency evaluation, all of which have achieved integrated development and large-scale production of both active pharmaceutical ingredients (APIs) and formulations. The company holds 29 domestic API registration numbers, with 24 having been upgraded to Class A status.

The successive approvals of the company’s products have enhanced its industry competitiveness, further optimized its product portfolio, and helped better meet market demand.

Teray Pharmaceutical Inc.’s rapid growth has been driven by the relentless efforts of every employee, as well as the trust and support from governments at all levels and our valued partners. Teray will rise to the occasion, striving for excellence in both conduct and character, seizing every moment, living up to its prime, and moving forward hand in hand with its partners.