Polyethylene glycol recombinant human somatropin(Changchun Genescience)

TAIPEI, Nov. 17, 2020 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO) ("Foresee") announced today that it has entered into an exclusive license agreement with GenScience Pharmaceuticals ("GenSci") - a wholly-owned subsidiary of Changchun High-Tech Industry (Group) Co., Ltd. (000661.SZ) - for the commercialization of Foresee's novel FP-001 program, Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous 6-month and 3-month depot formulations ("Camcevi™"). The license agreement will cover the China market. Under the terms of this partnership, Foresee, a Taiwan and US-based biopharmaceutical company, will receive 8 million US dollars upfront, and a combination of regulatory milestones, technology transfer milestones, and commercialization milestones payments totalling up to 123.85 million US dollars in addition to a share of the product revenue in the territory. GenSci will cover all costs of development, registration, and commercialisation in the territory. "GenSci has an impressive record developing and commercializing hormonal therapeutics in the China market and possesses extensive experience, expertise and infrastructure in R&D, regulatory affairs, manufacturing and commercialization," said Dr. Ben Chien, Founder and Chairman of Foresee. "Camcevi™ 6-month depot is currently under review process by the FDA and EMA, and will soon be followed by Camcevi™ 3-month depot. This important collaboration with GenSci will allow us to aggressively move forward phase III registration studies, registration, and commercialization of Camcevi™ in China. We are highly confident in Camcevi™'s potential in the China market, and see this as the foundation to a potentially broader partnership with GenSci in the future, related to Foresee's SIF technology and related programs." Dr. Lei Jin, CEO of GenSci said, "GenSci is very committed to bringing complex, added value products to the China market, improving the standard of care and ultimately the lives of patients. We are very pleased to have established a partnership with Foresee and look forward to a successful registration and launch of the FP-001 franchise in China. The products will provide meaningful advantages and benefits to patients and all medical practice stakeholders." About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, secondly its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs. Foresee's product portfolio includes late stage and early stage programs such as FP-001, 6-month and 3-month, stable, ready-to-use versions of leuprolide mesylate for injection, for which regulatory approval reviews are currently underway in US and EU for the 6-month product and regulatory submissions for 3-month product are in preparation; FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in a Phase 2 proof-of-concept study, and target to initiate Phase 2 study for COVID-19 virus induced acute respiratory distress syndrome (ARDS); FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia, and FP-004, a novel, subcutaneously injectable product in development for the treatment of opioid use disorder and pain. About Changchun High-Tech Industry and GenScience Pharmaceiticals GenScience Pharmaceuticals Co., Ltd. is a 99.5% owned subsidiary of Changchun High-tech Industry (Group) Co., Ltd.. CCHT was established by Changchun High-tech Industry Development Corporation in June 1993. On December 18, 1996, CCHT stocks were listed at Shenzhen Stock Exchange. Since its establishment, CCHT has successfully transformed from an infrastructure construction company into an enterprise group focusing on medical science, technology innovation, and industrial investment, with biopharmaceutical industry as its primary focus and real estate industry as the supplement. With a platform of genetic engineering pharmaceuticals, biological vaccines and modern traditional Chinese medicine, CCHT's subsidiaries includes GeneScience Pharmaceuticals Co., Ltd. ("GenSci"), Changchun BCHT Biotechnology Co., Ltd., Jilin Huakang Pharmaceutical Co., Ltd., and Changchun High-tech Real Estate Development Co., Ltd.. CCHT ranked 73rd and 56th among the top 100 pharmaceutical industries in China in 2017 and 2018, respectively. GenSci, established in 1996, is one of the leading genetic engineering pharmaceutical companies in China. With eight products on the market, including Somatropin, PEG-Somatropin, Follitropin, Molgramostim Gel, Octreotide and Triptorelin, etc., GenSci is also the largest manufacturer of recombinant human growth hormone in Asia. GeneSci provides services for reproductive, autoimmune, ophthalmology, nervous system fields. SOURCE Foresee Pharmaceuticals Co., Ltd.