Qilu Pharma Discloses First Clinical Data of Domestic PROTAC Drug QLH12016 Targeting Androgen Receptor in mCRPC Patients

Oct 18, 2025 19:55 CST Updated 19:55

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Recently, the full text of regular abstracts for the ESMO 2025 Congress was released. At this conference, Qilu Pharmaceutical disclosed its PROTAC drug.QLH12016The first clinical data. The drug targets the androgen receptor (AR).

As of February 14, 2025, a total of 36 patients with metastatic castration-resistant prostate cancer (mCRPC) were enrolled to receive QLH12016 (100-1200mg, once daily).TreatmentAll patients had metastatic disease, with 28% of patients having visceral metastases (lung, 11.1%; liver, 2.8%). 69.4% of patients had ligand-binding domain wild-type.（LBD wt），30.6% of patients had LBD mutations (including L702H).

The results showed that inWithin the dose range of 100-1200mgNo dose-limiting toxicity (DLTs) was observed. Treatment-related adverse events (TRAEs) occurred in 33 patients (91.7%), with 14 experiencing grade 3 or higher TRAEs. The most common TRAEs were anemia (n=23, 63.9%), asthenia (n=17, 47.2%), and weight loss (n=15, 41.7%). NoGrade 3 and aboveGastrointestinal TractTRAEs。Grade 3 and aboveHematologyTRAEsUncommon (anemia, 5.6%; decreased neutrophil count, 2.8%).

In terms of efficacy, the entire population,600mg dose group (n=13) and 900mg (n=10)The median radiographic progression-free survival (rPFS) was 7.4 months, 9.0 months, and not yet reached, respectively.In summary, QLH12016 demonstrated promising efficacy regardless of LBD status.

Source of the article: PharmaCube Info

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