Suzhou Alphamab Co., Ltd.,a leading biotechnology company, has initiated a phase I trial for its leading proprietary programme KN015 in China, marking a key milestone achievement for Alphamab in its pursuit of developing innovative biologics medicine.

KN015 is a long-acting human follicle-stimulating hormone (FSH). FSH is used clinically for infertility treatment, i.e. controlled ovarian stimulation (COS) in combination with a GnRH (Gonadotropin releasing hormone) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology programme. So far all the approved FSH products, such as Gonal-F and Elonva, need multiple injections in the treatment cycle. The current market sales for FSH products in China is over $330 million, and is forecast to grow significantly with the increasing infertility population, which is primarily attributed to environmental changes, higher stress level, and pregnancy at an older age.

In the preclinical studies, KN015 has shown longer in vivo half-life and similar bio-activity as compared to Gonal-F. Thus this product profile makes feasible a single subcutaneous injection of KN015 in a COS treatment cycle.

“We are very excited about moving our first proprietary biologics into clinical testing,” said Dr. Ting Xu, chairman and CEO of Alphamab. “With the superior efficacy and safety shown in preclinical studies, KN015 could offer patients the important benefits in treatment compliance, as well as reduction in stress and cost attributed to an otherwise daily injection of short-acting FSH. We very much look forward to working with clinical experts in this field to develop KN035 as a valuable addition to the currently available treatments.”

Suzhou Alphamab Co., Ltd., founded in 2009, is a leading biotechnology company in China focused on the discovery, development and manufacture of innovative biologics therapeutics.