Iruplinalkib is under clinical development by Qilu Pharmaceutical and currently in Phase II for Inflammatory Myofibroblastic Tumor (IMT). According to GlobalData, Phase II drugs for Inflammatory Myofibroblastic Tumor (IMT) does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Iruplinalkib LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Iruplinalkib overview

Iruplinalkib (Qixinke) is a pyrazolylpyridine derivative acts as anti-cancer agent. It is formulated as tablets for oral route of administration. Qixinke is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after previous crizotinib therapy or who are intolerant to crizotinib.

Iruplinalkib (WX-0593) is under development for the treatment of advanced solid tumors,  lymphoma, inflammatory myofibroblastic tumor and non-small cell lung cancer. The drug candidate is administered through oral route as a tablet. The drug candidate acts by targeting anaplastic lymphoma kinase (ALK).

Qilu Pharmaceutical overview

Qilu Pharmaceutical (Qilu) develops, manufactures and markets generic drugs and active pharmaceutical ingredients (API’s). It offers products for various therapies such as oncology, cerebrovascular and cardiovascular diseases, infectious diseases, psychological and neurological diseases, respiratory system and eye diseases. The company’s generic drugs include lyophilized powder for injection, powder for injection, small volume parenteral solution, tablets, capsules, granules, ophthalmic solutions, creams, ointments, inhalers and spray; and synthesized, lyophilized, sterile crystallized and fermented APIs. Qilu operates manufacturing facilities with various certifications of US FDA, European Medicines Agency (EMA), PMDA of Japan, Medicines and Healthcare products Regulatory Agency (MHRA) of UK, Therapeutic Goods Administration (TGA) of Australia and other national regulatory authorities. The company markets products across North and South America, Europe, Asia Pacific, and the Middle East and Africa. Qilu is headquartered in Jinan, Shandong, China.

For a complete picture of Iruplinalkib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.