Yasheng Pharmaceutical-B (06855) Global Registration Phase III Clinical Study for Nellick® First-Line Treatment Ph+ ALL was approved by the US FDA and European EMA

Zhitong Financial App News, Yasheng Pharmaceutical-B (06855) issued an announcement. The company's original Class 1 drug olevatinib (trade name: Nellick®) combined with chemotherapy to treat newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphocytic leukemia (ALL) patients) received approval from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to carry out a globally registered phase III clinical study (POLARIS-1, NCT06051409). As the second global registration phase III study approved by European and American regulators, the POLARIS-1 study was simultaneously enrolled in multiple centers in multiple countries, which will accelerate the listing process of Nellick® globally, especially in the European and American markets.

The POLARIS-1 study is an international multi-center, randomized controlled, and open global phase III clinical trial aimed at evaluating the efficacy and safety of Nelick® combination chemotherapy in newly diagnosed Ph+ ALL patients. The POLARIS-1 study was approved for clinical trials by the Chinese CDE in 2023 and was quickly launched.

It is worth mentioning that the latest developments in POLARIS-1 research will also be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting. This is the first time that data from this study will be announced. The summary data that has been disclosed so far shows that among first-time Ph+ ALL patients treated with Nellick® combined with low-intensity chemotherapy, the three-week molecular MRD (minimal residual disease) negative rate and the negative molecular MRD CR (complete remission) rate can reach about 65%, which is significantly improved compared to similar foreign products under the same conditions; even for some high-risk subtypes such as patients with IKZF1plus genetic variants, good curative effects have been achieved. At the same time, the joint program has excellent safety performance, low incidence of side effects, and is controllable.

Ph+ ALL accounts for about 20% to 30% of adult ALL patients, and has the characteristics of mainly incidence in old age, high recurrence rate, short survival time without disease, and poor prognosis. Prior to the introduction of TKI, a small-molecule targeted drug, the 5-year overall survival (OS) rate for Ph+ ALL was less than 20% with chemotherapy alone. The application of TKI has significantly changed treatment prospects in this field, but first-generation and second-generation TKI treatments still have certain limitations for patients with pH+ ALL.

Nellick® is Yasheng Pharmaceutical's original Class 1 new drug. It is an oral third-generation TKI and the first third-generation BCR-ABL inhibitor approved for marketing in China. Yasheng Pharmaceuticals and Cinda Biopharmaceuticals are jointly responsible for its commercialization promotion in China. Currently, Nellick® has been approved for treatment in a number of CML drug resistance fields in China, and all approved indications have been included in the national medical insurance drug catalogue. At the same time, Nellick® is deeply deployed in the Ph+ ALL field, and treatment for the Ph+ ALL field has been continuously recommended by the “CSCO Guidelines for the Diagnosis and Treatment of Malignant Hematology” and has been recognized as a breakthrough therapy by CDE.

On June 14, 2024, Yasheng Pharmaceuticals and global pharmaceutical company Takeda signed an exclusive option for olevatinib. Once the option is exercised, Takeda will obtain a global license to develop and commercialize Nellick®, with the exception of mainland China, Hong Kong Special Administrative Region of China, Macau Special Administrative Region of China, and Taiwan.