이 기사는 2021년 11월 14일 16:16 thebell 에 표출된 기사입니다.

Blueprint Medicines, a Massachusetts-based precision therapy company, signed last Tuesday a license agreement with Chinese oncology specialist Zai Lab in a deal that proves the market for next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors targeting the C797S mutation, which is also being developed by Bridge Biotherapeutics.

The deal will give Zai Lab, listed both on the Nasdaq and in Hong Kong, the exclusive right to develop and commercialize BLU-945 and BLU-701 for the treatment of patients with EGFR-driven non-small cell lung cancer (NSCLC) in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

Under the agreement Blueprint Medicines will receive an upfront cash payment of $25 million, with up to $590 million in potential future milestone payments as well as tiered royalties.

There are several companies in the world working on developing fourth-generation EGFR tyrosine kinase inhibitors. But Blueprint Medicines and Bridge Biotherapeutics, headquartered in Pangyo, South Korea, are the only two companies whose treatments are in clinical trials.

BLU-945 targets EGFR activating mutations combined with T790M and C797S resistance mutations, while BLU-701 targets C797S. Bridge Biotherapeutics’ BBT-176 also specifically targets the C797S mutation. These compounds have first-in-class potential for next-generation EGFR treatment.

“We are about six months ahead in terms of the clinical trial progress,” said James Jung-kue Lee, chief executive of Bridge Biotherapeutics. “This licensing agreement indicates the growth potential of the market for a C797S mutation treatment.”

Bridge Biotherapeutics launched a Phase 1/2 trial of BBT-176 in April this year, aiming to commercialize it in the United States. “We expect to share clinical trial data earlier than Blueprint Medicines,” Lee said.

BLU-945 is currently in a Phase 1/2 trial, with Blueprint Medicines planning to initiate a Phase 1/2 trial of BLU-701 in the fourth quarter of 2021. BLU-701 has shown significant central nervous system (CNS) penetration in preclinical studies, which is meaningful especially for EGFR-mutant NSCLC patients with CNS metastases.

“With more than 800,000 newly diagnosed lung cancer patients annually, one of the highest EGFR mutation rates in the world, and with no available therapies to address on-target resistance to early-generation EGFR therapies, we believe we have a tremendous opportunity to improve patient care in China,” said Dr. Samantha Du, founder and chief executive of Zai Lab.

Lung cancer is the most commonly diagnosed cancer type in China, Zai Lab said. About 85% of new cases of lung cancer in China are NSCLC, with EGFR mutations occurring in 40-50% of NSCLC patients. The most commonly prescribed in China are third-generation EGFR-tyrosine kinase inhibitors including osimertinib.

Other South Korean pharmaceutical companies with EGFR therapy pipelines include Yuhan Corporation and Hanmi Pharmaceutical.

Yuhan Corporation signed a licensing deal with Janssen for lazertinib, a third-generation EGFR tyrosine kinase inhibitor, in 2018. It received $50 million in upfront money and is eligible for up to $1.25 billion in milestone and royalty payments. The drug candidate is in late-stage clinical trials.

Hanmi Pharmaceutical in 2015 licensed its poziotinib for the treatment of NSCLC to US-based Spectrum Pharmaceuticals. The drug candidate was granted Fast Track designation by the US Food and Drug Administration earlier this year, with Spectrum planning to submit a new drug application. (Reporting by Jeong-yeo Lim)