Chinese Biotech Qihan Pharma Submits IPO Prospectus Following Clinical Collaboration with AstraZeneca on SHP2 Inhibitor GH21

Apr 10, 2024 11:56 CST Updated 11:56

GEN HOUSE

Developer of Small Molecule Anticancer New Drugs

AstraZeneca

Biopharmaceutical Manufacturer

April 9, 2024, Suzhou, China — GEN HOUSE, a research and development company dedicated to utilizing a combination technology platform to develop a new generation of global anti-tumor small molecule drugs, announced today,GEN HOUSE Establishes Clinical Research Collaboration with AstraZeneca to Explore SHP2 Inhibitor GH21 in Combination with Osimertinib Mesylate for the Treatment of Non-Small Cell Lung Cancer (NSCLC).

This is an open-label, multi-center, Phase Ib/II study designed to evaluate the combination therapy in patients with epidermal growth factor receptor（EGFR）Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Administration in Patients with Mutated Advanced NSCLC. The leading institutions are Shanghai Pulmonary Hospital and Hunan Cancer Hospital, and the first patient has recently completed the initial dosing.

GEN HOUSE Chief Medical Officer Dr. Wang Haidan said:

Many tumors evolve during treatment, making it difficult for a single drug to achieve long-term therapeutic goals. Combinations of certain treatment drugs have shown exciting clinical benefits in both clinical trials and real-world treatment practices, with combination therapy considered a trend in the clinical treatment of tumors. This study aims to confirm that the combination of GH21 and Osimertinib can improve the efficacy of NSCLC, offering prolonged benefits for more patients.

GH21It is a small molecule inhibitor targeting SHP2 and is effective against various SHP2 point mutants. SHP2 is located downstream of most receptor tyrosine kinases.（RTK）Downstream, mediating key signaling pathways for cell growth and survival; SHP2 is also downstream of immune checkpoints such as PD1 and BTLA, mediating tumor immune escape signals, which has received widespread attention in recent years. Studies in vivo and in vitro have shown that GH21 has low off-target risk, high oral bioavailability, and a large safety window, making it a small molecule anti-tumor drug with significant development potential. Non-clinical studies indicate that GH21, used alone or in combination with other anti-tumor drugs, is effective against various solid tumors. Currently, GH21 has entered clinical trials in both China and the United States, with the U.S. clinical trial led by strategic partner HUYA Bio International. GH21 has demonstrated favorable PK and safety in clinical studies, with efficacy signals observed even at low doses.

OsimertinibA third-generation EGFR tyrosine kinase inhibitor（TKI）, has brought significant clinical benefits to patients with NSCLC. However, with long-term use, drug resistance has gradually emerged, and the mechanisms of resistance have become more complex, involving secondary EGFR mutations such as C797S mutation, bypass RTK activation such as MET amplification, and transformations to small cell lung cancer, squamous cell carcinoma, and sarcoma, among others. Therefore, effective treatment strategies for drug resistance to third-generation EGFR TKIs are still urgently needed.

Studies show that the combination of SHP2 inhibitors and osimertinib has the potential to enhance clinical benefits for patients. In preclinical studies, the combination of GH21 and osimertinib demonstrated efficacy in models with EGFR C797S mutation/MET amplification, offering new possibilities for future clinical treatment.

Dr. Ming Liu, Chief Business Officer of GEN HOUSE, said:

We are delighted to have reached this collaboration with AstraZeneca. As GEN HOUSE’s innovative drug pipeline advances, we look forward to establishing more extensive strategic partnerships with multinational pharmaceutical companies.

About GEN HOUSE

GEN HOUSE is a biotechnology company focused on the development of globally leading small-molecule anti-cancer drugs. The company's management team has years of experience in enterprise management, new drug research and development, and clinical medical research, and is committed to overcoming "undruggable" targets while focusing on original innovation. GEN HOUSE is dedicated to building a distinctive R&D system for innovative drugs, establishing a structure-activity relationship research platform based on structural biology, an early drug screening platform based on target research, and a preclinical evaluation platform covering efficacy, metabolism, and safety studies, forming a product pipeline centered on targeted anti-cancer therapies.

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