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PharmaBlock and Shouyao Enter into CMC Development and Manufacturing Agreement to Advance ALK Inhibitor SY-707 towards NDA

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PharmaBlock Sciences (Nanjing), Inc. (“PharmaBlock”, 300725.SZ), a leading innovative chemistry products and services provider throughout the pharmaceutical R&D process and commercialization, and Shouyao Holdings Co., Ltd. (“Shouyao”), a biopharmaceutical company focusing on innovative tumor and diabetes drug development, recently announced a strategic partnership for the CMC development and manufacturing of Shouyao’s leading program, a second-generation ALK inhibitor for non-small cell lung cancer (SY-707).


Shouyao has 16 clinical approvals by China NMPA (National Medical Products Administration), two of which have entered Phase II clinical trial, two in Phase III. SY-707 is a new generation of highly active ALK/FAK/IGF1R multi-target kinase inhibitor independently developed by Shouyao. It is currently in a critical Phase II/III clinical study and has received conditional Phase II approval in China.

 

PharmaBlock and Shouyao have engaged in long-term and broad collaboration for innovative drug development. The signing of the SY-707 project agreement makes it a milestone in the partnership between the two companies. Under the agreement, PharmaBlock will provide integrated CMC services, including drug substance development and manufacturing, and NDA (New Drug Application) regulatory support to advance SY-707 from late-phase clinical trials to commercialization.

 

“PharmaBlock is a highly professional and trusted CMC partner. Over the past years of close collaboration, PharmaBlock has helped us break the bottlenecks on many projects through innovative, efficient, and flexible solutions,” Said Wenjun Li, Chairman of Shouyao, “We are pleased to secure PharmaBlock’s CMC services on this crucial project of SY-707. We hope that the partnership with PharmaBlock will help us accelerate the launch of SY-707 and deliver our commitment to NSCLC (non-small cell lung cancer) patients.” 

 

“We are delighted to further our collaboration with Shouyao,” said Dr. Minmin Yang, Chairman of PharmaBlock, “Our ever-changing mission is leveraging the top-notch expertise in CMC and new technologies to help partners accelerate drug discovery and development, and move the new molecules into the market at full speed.”

 


About PharmaBlock

PharmaBlock Sciences (Nanjing), Inc. (SZSE:300725) is a leading provider of innovative chemistry products and services throughout the pharmaceutical R&D process and commercialization. Its core businesses include a rationally designed building block collection for discovery, development, and commercialization; development and manufacturing of RSMs, intermediates, APIs, and drug products for drug development and commercialization. Integrating cutting-edge technologies such as continuous flow chemistry, micropacked bed technology, catalysis, and AI, the company is exploring green, safe, and intelligent manufacturing models to promote the innovative development of the biopharmaceutical industry.

 

 

About Shouyao Holdings

Shouyao Holdings Co., Ltd. is primarily engaged in the research and development of small molecule anti-tumor targeted drugs and new diabetes drugs. Shouyao Holdings has developed 16 clinical approvals by China NMPA, two of which have entered phase III clinical trials.