
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On May 23, the CDE official website showed that Qilu Pharmaceutical's Class 1 new drugs, QLH11906 tablets and QL1706 injection, received implied permission for clinical trials, intended for advanced solid tumors and small cell lung cancer. So far this year, Qilu Pharmaceutical has had six Class 1 new drugs approved for clinical trials.
Small-molecule chemical drug QLH11906 tablets have been approved for clinical trials for the first time, indicated for advanced solid tumors with abnormal MAPK signaling pathways; large-molecule biologic drug QL1706 injection (PD-1/CTLA-4 bispecific antibody) has received additional clinical trial approvals for the treatment of extensive-stage small cell lung cancer.
Since the beginning of this year, Qilu Pharmaceutical has received clinical approval for six Class 1 new drugs, including QL1706 Injection, QLH11906 Tablets, QLS31904 for Injection, QLS21908 for Injection, QL1604 Injection, and QLS31906 for Injection.
New Class 1 Drugs Approved for Clinical Use by Qilu Pharmaceutical from 2022 to Present
Except for QLS21908 for injection used for autoimmune diseases, all other Class 1 new drugs belong to the field of cancer treatment.
Data from MiNe Network shows that in recent years, the domestic anti-tumor drug market in China has continued to expand. In 2021, terminal sales in Chinese urban public hospitals, county public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) approached 115 billion yuan, representing a year-on-year increase of 11%.
Sales of Anti-Tumor Chemical Drugs in Chinese Public Medical Institutions (Unit: 10,000 Yuan)
Source: Terminal Competition Pattern of Public Medical Institutions in China, MiNe Network
In recent years, Qilu Pharmaceutical has adhered to an innovation-driven strategy and continuously increased its investment in scientific research. In 2021, Qilu Pharmaceutical's R&D investment reached 3.32 billion yuan, accounting for nearly 10% of its sales revenue. Currently, Qilu Pharmaceutical has 26 Class 1 new drugs in the clinical application stage or above.
Data source: MiNeiNet database, NMPA