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HaiHe Biopharma Obtains the IND Implied License from FDA for its Innovative Drug EZH1/2 Dual Inhibitor

December 10, 2019, Shanghai, China - HaiHe Biopharma, a company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, and Taiwan Microbio Group (hereinafter referred to as “Microbio”) announced that the interim investigator meeting on the phase III clinical trial of ON101, an innovative drug for the treatment of diabetic foot ulcer jointly developed by the two companies, was successfully held in Shanghai. The clinical trial was led by Academician Ning Guang from Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine.

About Diabetic Foot Ulcer

The diabetic foot refers to the damages of skin and deep tissues beyond the ankle joint in diabetic patients, often associated with infection and/or arterial occlusive diseases of lower limbs in different degrees, and in severe cases involving muscle and bone tissues [1]. The diabetic foot is one of the most serious chronic complications that cause disability and death of diabetic patients in China. The morbidity of diabetic foot in diabetic patients over 50 years old in China is 8.1%. Diabetic foot ulcer (DFU) is the most common manifestation of diabetic foot. Based on data from abroad, the diabetic patients account for 40%~60% of all non-traumatic lower amputations, and 85% of lower distal amputations related to diabetes occur after the development of foot ulcers. The annual mortality in DFU patients reaches 11%, and in the amputees is as high as 22% [2]. The diabetic foot features high incidence, high recurrence rate, difficult to treat and huge cost. Currently, there are very few drugs for treating the diabetic foot ulcer in the world. Therefore, urgent market demands, and huge unmet clinical needs are present.

About ON101

ON101 refers to a topical drug for treating diabetic foot on which HaiHe Biopharma Co., Ltd and Microbio are conducting phase III clinical trial in China, which is an ointment made of Plectranthus amboinicus/Centella Asiatica extract, to promote the healing of lower limb ulcers in patients with diabetes. Patchouli Essential Oil has been shown to have growth inhibition effects on bacteria and fungi, and its extract has been reported to have antioxidant and anti-breakage effects. The active extracts of Centella Asiatica have also been shown to promote wound healing. The international multicenter phase III clinical trials in the United States, Mainland and Taiwan China are progressing well.

About Haihe Biopharma

Haihe Biopharma focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, “Inclusive and open to diversity, innovation oriented to win together and benefit the mankind”, Haihe Biopharma insists on the way of independent innovation and pursues for global development of Chinese original innovative drugs in partnership with Shanghai Institute of Materia Medica, Chinese Academy of Science (SIMM). The company is led by an academician of the Chinese Academy of Engineering. The senior management team has extensive experiences in drug research and development in China and abroad. Haihe Biopharma has built a precision medical platform guided by biomarkers, and established a fully integrated pre-clinical evaluation technical platform and clinical study system for innovative drugs, with advanced technology and operation in consistence with international standards and norms, covering subunits from compound synthesis, CMC study, biomarker discovery and validation, medical strategy and clinical study, etc. The company has established a globally competitive innovative drug R&D system and robust product pipeline. There are 7 compounds in clinical and 3 compounds in preclinical studies, among which 7 compounds are discovered in-house.

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About Microbio Group

The members of Taiwan Microbio Group include Microbio, Oneness Biotech, Microbio (Shanghai), Microsoy, Cotton Field, Diamond Biofund and Sun Biofund. Since its establishment in 2000, Microbio Group remains dedicated to “novel therapeutics development and human lifestyle improvement”. MICROBIO Group’s approach to innovative and responsible drug development has led to two successful drug approvals by the Taiwanese Food and Drug Administration (TFDA). The Group has successfully developed a number of microbial pharmaceutical technology platforms. Furthermore, it has made several significant breakthroughs in the field of biotechnology and won a number of awards and honors, including the National Biotechnology Medical Quality Award, the Biomedical Innovation Award. At present, the Group has more than ten innovative drugs undergoing pre-clinical and human clinical studies, including botanical drugs, chemical drugs, antibodies and glycans new drugs. Microbio Group has been taking firm steps forward in pursuit of expansion of its new drug business thanks to its excellent R&D team and strong innovation strength. In addition to drug development, Microbio Group has expanded into other markets such as top-line medical devices, functional health foods, organic agricultural products, and biotechnology venture capital, and has established strategic collaborations with renowned research institutions both at home and abroad, international major pharmaceutical companies as well as upstream and downstream bio-tech enterprises. In adherence to the corporate culture of “modesty, positivity, humility and innovation”, the Group conducts operation with diligence and prudence and seeks truth from facts while taking steady steps towards internationalization.

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