Qilu Pharmaceutical's Class 1 New Drugs Surge Amid a RMB 150 Billion Anti-Tumor Market

Data from MiNe Network shows that Qilu Pharmaceutical's Class 1 new biological drug, QLS32015 for injection, recently completed the enrollment of its first participant in Phase III clinical trials, becoming China’s first GPRC5D/CD3 bispecific antibody to enter Phase III clinical trials. In 2024, across China’s three major terminals and six key markets, the market size of anti-tumor drugs (chemical + biological) is expected to exceed 150 billion yuan, maintaining a high growth rate for the third consecutive year, indicating vast market potential.

According to the official WeChat account of Qilu Pharmaceutical, injectable QLS32015 is a GPRC5D/CD3 bispecific antibody. The company submitted its first clinical trial application for a Class 1 new drug in April 2023, which was approved in June of the same year for the indication of multiple myeloma. In April this year, the company submitted another clinical trial application, and in June, it was approved for use in combination with pomalidomide, or in combination with daratumumab, or in combination with pomalidomide and daratumumab, or in combination with bortezomib and lenalidomide for the treatment of multiple myeloma. In early November, the first participant in the Phase III clinical trial of injectable QLS32015 for multiple myeloma was successfully enrolled.

Earlier research data showed that the safety and tolerability of injectable QLS32015 were good, and it demonstrated significant efficacy comparable to CAR-T in patients with relapsed or refractory multiple myeloma, exhibiting potential breakthrough clinical value. Qilu Pharmaceutical stated that injectable QLS32015 is expected to become the first GPRC5D/CD3 bispecific antibody drug approved for marketing in China, offering a new treatment option for patients with multiple myeloma.

In China's three major terminals and six major markets (the statistical scope is described at the end of the article), the market size of anti-tumor drugs (chemical + biological) has experienced continuous positive growth since 2023, exceeding 150 billion yuan in 2024, with a growth rate of over 9% in the first half of 2025.

In the first half of 2025, in the three major terminals and six key markets in China, Qilu Pharmaceutical ranks as the TOP4 group (Tier 1) in anti-tumor drugs (chemical + biological), with its TOP20 products collectively capturing over 4.7 billion yuan. The company’s two Class 1 new drugs, Eparlolib-Tovorolimab Injection and Irulac Tablets, have seen continuously soaring sales since their launch, showing significant potential.

Currently, Qilu Pharmaceutical has more than 20 novel Class 1 anti-tumor drugs actively progressing in clinical trials. In addition to Injectable QLS32015, the Phase III clinical trial for pancreatic cancer with Injectable QLS31905 also enrolled its first participant this September. As more new drugs enter the market, the company’s competitiveness in the anti-tumor drug market will rapidly increase.