AffaMed Therapeutics Announces Approval for the Phase IIb Clinical Study of AM006 in China for the Treatment of Parkinson's Disease

AffaMed Therapeutics, a global clinical stage biopharmaceutical company dedicated to addressing critical unmet medical needs in ophthalmic, neurological and psychiatric disorders, today announced that China's National Medical Products Administration (NMPA) has approved the Clinical Trial Application (CTA) for a Phase IIb global clinical trial led by AffaMed to evaluate the safety and efficacy of AM006 in patients with early Parkinson's Disease (PD). AM006 is a novel non-ergot dopamine agonist (DA) under development to improve the symptoms of PD, which acts by stimulating striatal dopamine receptors.

PD is a common neurodegenerative disease, whose main manifestations are motor system disorders like resting tremor, bradykinesia, myotonia and postural balance disorders, as well as non-motor symptoms such as emotional and cognitive dysfunction. The precise cause of PD is unknown with some cases being hereditary while others are thought to occur from a combination of genetics and environmental factors that trigger the disease. China today represents approximately 5% of the global market for PD treatments, with Europe, the United States, and Japan currently being the main treatment markets. By 2030 however, China is expected to account for close to 50% of PD patients globally, illustrating the significant scale of treatment needs required to be met in the future.

Dr. Zhao Dayao, CEO of AffaMed, commented, "There are huge unmet treatment needs for people suffering from Parkinson's disease in China and around the world. We are pleased to receive this CTA approval from NMPA for AM006 in such a short timeframe, just 7 months after the product was in-licensed by our company. This approval is an important milestone for AffaMed as it initiates its first multi-regional clinical trial (MRCT), and exemplifies the great potential of our team to strategically allocate resources, and efficiently execute clinical development plans. We expect this drug to fill gaps in existing treatments and ultimately improve patients' lives."

AM006 is a promising novel drug for PD. Results from previous studies suggest that AM006 may reduce the risk of developing adverse reactions reported with existing DAs (including valvular heart disease, somnolence, sudden onset of sleep, and impulse control disorder). It has a sustained and stable amelioration effect on motor symptoms of PD by once-daily administration. Compared to the existing DAs, AM006 has a higher affinity for dopamine receptors, and more balanced activation of D2 and D3 receptors. In October 2020, AffaMed entered into an exclusive licensing agreement with Kissei Pharmaceutical Co., Ltd. to develop and commercialize AM006 (also known as "KDT-3594"), in Greater China (Mainland China, Taiwan, China, Hong Kong, S.A.R., China, and Macau, S.A.R., China), and Southeast Asia (Singapore, Malaysia, Thailand, Indonesia, Vietnam, and the Philippines).

Globally, AM006 is in the Phase IIb stage of clinical development, with CTA's approved in Singapore and Mainland China in April and May 2021, respectively.

About AffaMed Therapeutics

AffaMed Therapeutics is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs in ophthalmic, neurological and psychological disorders for patients in Greater China and around the world. The leadership team of AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality clinical development, regulatory affairs, CMC, business development and commercial operations at leading multi-national pharmaceutical companies in China and globally.

About Kissei Pharmaceutical Co., Ltd ("Kissei")

Kissei is a Japanese pharmaceutical company with approximately 70 years of history. It provides unique innovative pharmaceutical products as a drug discovery and R&D-oriented company for patients in the world with a special focus on urology, renal diseases, dialysis, and other therapeutics areas with high unmet medical needs.