Applied Biology and Kintor to Collaborate on the use of Proxalutamide for the Treatment of COVID-19

While studying the effects of androgens on hair loss, Applied Biology scientists discovered an association between cellular receptors that predispose an individual to develop common hair loss (androgenetic alopecia) and COVID-19. The receptors called Androgen Receptors (AR) are expressed in lung cells and regulate a key enzyme (TMPRSS2) required for SARS-CoV-2 infectivity. Applied Biology scientists are believed to be the first to publish this discovery in the medical journal Dermatologic Therapy "WHAT DOES ANDROGENETIC ALOPECIA HAVE TO DO WITH COVID-19? AN INSIGHT INTO A POTENTIAL NEW THERAPY" Article DOI: 10.1111/dth.13365

Following their discovery, Applied Biology initiated several clinical studies to elucidate the potential role of androgens in COVID-19 infection. The clinical study "Anti-Androgen Treatment for COVID-19" (NCT04446429) is a randomized controlled study of an anti-androgen (5-alpha reductase inhibitor) as a treatment for mildly symptomatic COVID-19 patients. In their attempt to accelerate a potential new therapy for COVID-19, Applied Biology scientists are seeking to collaborate with pharmaceutical companies with novel anti-androgens in the pipeline.

Suzhou Kintor Pharmaceutical, Inc.* (????????????), a wholly-owned subsidiary of Kintor Pharmaceutical Limited ("Kintor Pharma", 9939.HK), is in phase II studies in the US and two phase III studies in China with its lead anti-androgen drug candidate Proxalutamide (GT0918). The NDA filing of Proxalutamide with the Chinese CDE is scheduled for 2020. Proxalutamide (GT0918) is a potential best-in-class small molecule AR antagonist for the treatment of mCRPC based on well-researched AR mechanism and has a novel chemical structure that enables it to down regulate AR expression.

According to Prof. Dr. Andy Goren, Chief Medical Officer of Applied Biology: "We are excited to partner with Kintor Pharma to study, what we believe is, the first novel molecule that reduces the expression of both TMPRSS2 and ACE2, the two molecules implicated in SARS-CoV-2 infectivity. Provided our study demonstrates efficacy and safety, Proxalutamide could potentially be used as a first line treatment for COVID-19 male patients at the early stage of infection."

Dr. Tong Youzhi, the Founder, Chairman and CEO of Kintor Pharma, said:" Coronavirus is continuing its spread across the world with more than 12 million confirmed cases in 188 countries. More than half a million people have lost their lives. While research institutes and pharmaceutical companies are actively pursuing therapies to prevent or treat coronavirus, it is critical to find a treatment that helps COVID-19 patients slow the progression. By doing so, the human immune system may have sufficient time to generate antibodies to fight against the novel coronavirus. We believe this collaboration with Applied Biology will further explore a new meditation to treat COVID-19."

ABOUT APPLIED BIOLOGY

Founded in 2002, Applied Biology, Inc. (www.appliedbiology.com), headquartered in Irvine, California, is a biotechnology company specializing in hair and skin science. Applied Biology develops breakthrough drugs and medical devices for the treatment of androgen mediated conditions. Applied Biology's R&D pipeline includes a topically applied prophylactic treatment for chemotherapy induced alopecia; a novel diagnostic device that can aid dermatologists in identifying non-responders to topical minoxidil; an adjuvant therapy for non-responders to topical minoxidil; and a novel therapy for female pattern hair loss.

ABOUT KINTOR PHARMACEUTICAL LIMITED

Founded in 2009, Kintor Pharmaceuticals concentrates on the R&D and industrialisation of "best-in-class" and "first-in-class" innovative drugs, and strives to become a leading enterprise in the R&D and commercialization of innovative therapies. The Company was founded by national-level talents, after years of development, centered upon androgen receptor (AR) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as prostate cancer, breast cancer, liver cancer and hair loss. Kintor Pharmaceuticals has prospectively deployed a diversified product pipeline that includes small molecule innovative drugs, biological innovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog inhibitors, as well as AR-Degrader, c-Myc inhibitors and IDO inhibitors that are undergoing preclinical research. Globally, the Company owns more than 60 patents, many of which are listed as the "Major New Drugs Discovery" in National 12th and 13th Five-Year Plans by the Chinese government. On 22 May 2020, the Company was officially listed on the Hong Kong Stock Exchange with the stock code 9939.HK with USD240 million raised from the IPO.