Changes in Hong Kong stocks | Yasheng Pharmaceutical-B (06855) rose more than 6%, and Nellick® POLARIS-1 research was approved by the US FDA and European EMA

The Zhitong Finance App learned that Yasheng Pharmaceutical-B (06855) rose by more than 6%. As of press release, it had risen 5.67% to HK$64.2, with a turnover of HK$1993,300.

According to the news, on December 5, Yasheng Pharmaceutical-B announced that 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 (POLARIS-1, NCT06051409) was approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). ^{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.}

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-cycle 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.