ZhuoKai Bio Secures RMB 50 Million Series B Financing to Advance First-in-Class 1.1 Class Alzheimer’s Drug Targeting Forgetting Mechanism

VCBeat has learned that Beijing Zhuokai Biotechnology Co., Ltd. (hereinafter referred to as “Zhuokai Biotech”) recently announced the completion of its RMB 50 million Series B financing round. The round was led by Hetang Fund, with participation from Kinghand Capital, MSA Capital, and other institutional and individual investors.

This round of financing will be primarily used for the clinical studies of 50561, a Class 1.1 drug for the treatment of Alzheimer's disease; the preclinical studies of JK-new, a Class 1.1 new drug for amyotrophic lateral sclerosis (ALS); and the clinical studies of Agiforget, a Class 1 new compound formulation for autism.

Zhuokai Biotechnology was co-founded in 2001 by Professor Zhong Yi, a professor at Tsinghua University and the Cold Spring Harbor Laboratory in the United States, and Professor Wang Jian, a professor at the School of Pharmaceutical Sciences, Tsinghua University.

In its early stages, Zhuokai Bio primarily conducted research on human intelligent genes and Drosophila animal models in Tsinghua University’s laboratories, securing operational funding by providing drug screening services using Drosophila models to pharmaceutical companies such as Otsuka Pharmaceuticals, thereby developing its drug screening and discovery platform.In 2004, Zhuokai Biology began publishing papers proposing a transgenic Drosophila model of Alzheimer’s disease and reporting the discovery of genes associated with human memory.Subsequently, Zhuokai Biology has continued to publish papers on Drosophila animal models and human intelligence-related genes.

Since 2009, Zhuokai Biotech has received financial support from Ms. Xu Aihua, Chairwoman of Zhejiang Hualian Group, on multiple occasions. In 2016, Zhuokai Biotech secured funding from professional investment institutions such as the Zhongshan Beisen Medical Fund. From 2016 to 2019, the Beisen Medical Fund and other individual investors continued to invest in Zhuokai Biotech, with cumulative financing reaching RMB 31 million during this period.

To date, Zhuokai Biotech has been deeply engaged in the field of cognition-related diseases for two decades, focusing on addressing unmet market needs valued at hundreds of billions of dollars, including Alzheimer’s disease, autism, and amyotrophic lateral sclerosis (ALS).Through steady, step-by-step progress, Zhuokai Biologics has gradually established its unique mechanisms and therapeutic targets for treating amnesia. Focusing on the convergent pathways underlying cognitive impairment caused by diverse etiologies, Zhuokai Biologics has undergone 20 years of research and development,Secured the world’s first Class 1.1 novel small-molecule drug, 50561 (first in concept), which fully rescues cognitive deficits across multiple models by inhibiting forgetting, and is expected to alleviate dementia symptoms caused by various factors.

50561 received clinical trial approval from China’s Center for Drug Evaluation (CDE) in March 2021, accelerating its R&D progress. The safety study in healthy volunteers (Phase Ia) is expected to be completed by early 2022, and the efficacy study in patients (Phase Ib) by the end of 2022. Ma Weiwei, General Manager of Zhuokai Biopharma, stated, “Developing effective drugs for Alzheimer’s disease holds substantial market value and social impact.”Currently, more than a hundred drugs under development are all based on a single pathogenic mechanism. Since 2003, only two products have been approved by regulatory authorities worldwide: GV-971 from China’s Green Valley and Biogen’s aducanumab. The needs of the 20 million patients globally and the trillion-dollar market remain far from being met.

Except for 50561,Zhuokai Biotech also has a product pipeline covering several other neurological disease areas, including the commonly used pediatric drug Compound Agiforget for improving stereotyped behaviors in autism, and JK-new, a Class 1.1 small molecule designed to prevent neuronal death in amyotrophic lateral sclerosis (ALS). The company plans to complete preliminary efficacy studies (Phase I) and key preclinical studies (pre-IND) for these candidates by the end of 2022, respectively.

Looking ahead, Zhuokai Biotech will dedicate itself to the research and development of novel drugs for the nervous system, evolving into a biotechnology company with integrated R&D and clinical capabilities. By establishing strong collaborative relationships with Beijing Xuanwu Hospital, Peking Union Medical College Hospital, as well as numerous renowned doctors and professors in China specializing in cognitive disorders, Zhuokai Biotech has effectively advanced its clinical trials. Notably, Professor Jia Jianping from Xuanwu Hospital, a leading expert in the field of Alzheimer’s disease (AD), serves as the Principal Investigator (PI) for Zhuokai Biotech’s clinical trials; Professor Zhang Zhenxin from Xuanwu Hospital and Professor Xu Lin from the Chinese Academy of Sciences both serve on the company’s Scientific Advisory Committee. Furthermore, Zhuokai Biotech is currently in negotiations with prominent domestic and international biopharmaceutical companies regarding the out-licensing of U.S. rights for its product 50561.

Liu Gang, Executive Director of Beisen Medical Fund, stated: “There is a significant unmet need in the field of cognitive impairment disorders. Cognitive impairment is the primary symptom of Alzheimer’s disease, which affects tens of millions of patients in China. However, the current lack of effective therapeutic options imposes a heavy burden on society and causes immense suffering to patients and their families. Developing a truly effective drug in this sector holds enormous market potential.”

Zhuokai Bio’s pipeline products are among the few truly innovative drugs (novel concepts, novel targets, and new chemical entities) developed in China for Alzheimer’s disease.Founder Professor Zhong Yi is a leading neuroscientist in China. The product’s target was identified through decades of in-depth basic research, representing a hot topic in the field and demonstrating strong scientific persuasiveness.

“Beisen Medical Fund invested in Zhuokai Bio during the preclinical stage, providing comprehensive support along the way in areas such as preclinical trial planning, clinical trial design, regulatory communication channels, corporate strategic development, and even human resources. In the future, Beisen Medical Fund will continue to provide empowering services to the company. Particularly now that the company has reached a new level of development following this round of financing, Beisen Medical Fund will actively promote Zhuokai Bio’s growth into an international pharmaceutical R&D company specializing in the neurological field.”

Beijing Hetang Life Sciences Original Innovation Fund (Limited Partnership) (hereinafter referred to as “Hetang Fund”) was established in 2019. It was jointly initiated by Beijing SaiSheng Pharmaceutical Co., Ltd. and Hetang Venture Capital Management (Beijing) Co., Ltd. (hereinafter referred to as “Hetang VC”), and is managed by Hetang VC.

Huatong Venture Capital, established in 2001, is an integral part of Tsinghua University’s innovation ecosystem and serves as the investment management platform for technology transfer and commercialization of research achievements at Tsinghua University. The Huatong series of funds currently managed by Huatong Venture Capital includes the Huatong Exploration Fund, Huatong Innovation Fund, Huatong International Health Fund, and Huatong Life Sciences Original Innovation Fund, which focus respectively on the commercialization of scientific and technological achievements, regional industrial upgrading, and the healthcare industry.

KinghandCapital is a leading equity investment firm focused on the healthcare sector, dedicated to leveraging capital and industry resources to accelerate the growth of outstanding healthcare enterprises, deliver superior medical products and services to society, and advance human health.

Kinghand Capital manages ten RMB-denominated funds and two USD-denominated funds. Its portfolio includes investments in 55 high-quality projects. Between 2019 and 2020, nine of its portfolio companies were listed on the Hong Kong Stock Exchange (HKEX) and the STAR Market, including Sino Medical Sciences Technology Inc. (688108.SH), Viva Biotech Holdings (01873.HK), Jinxin Fertility Group Limited (01951.HK), and Anbiping Diagnostics Co., Ltd. (688393.SH). As of the current date in 2021, BKMed Healthcare (02170.HK), a company invested by Kinghand Capital’s funds, has been listed on the HKEX; additionally, two other portfolio companies have passed the listing committee reviews of the STAR Market and the ChiNext Board, respectively, while two more have had their initial public offering (IPO) applications accepted. It is expected that over ten additional portfolio companies of Kinghand Capital will be listed on major domestic and international stock exchanges in 2021 and 2022.

MSA Capital is a private equity investment firm deeply rooted in China with a global perspective, focusing on early-stage and growth-stage investments in key sectors such as healthcare, frontier technologies, internet, and consumer industries. Headquartered in Beijing, the firm maintains resident teams in the United States, the Middle East, and Africa. Leveraging its broad global vision and profound insights into international markets, the team not only identifies high-quality investment opportunities but also helps portfolio companies rapidly expand into overseas markets by leveraging local resources.

Currently, MSA Capital manages assets exceeding $1.5 billion, with investment portfolios including Meituan Dianping (SEHK: 3690), NIO (NYSE: NIO), BGI Genomics (SZ: 300676), Uber (NYSE: UBER), Yidu Tech (SEHK: 2158), BOSS Zhipin, SpeedBot Robotics, Zhaogang.com, Xiaozhu Short-Term Rental, Feibu Technology, Fordeal, T11 Fresh Supermarket, Suikun Intelligence, Yanming Biology, Zhiyun Health, Black Sesame Technologies, and Biren Technology.

References:

1.Koichi Iijima, Hsin-Ping Liu, Ann-Shyn Chiang, Stephen A Hearn, Mary Konsolaki, Yi Zhong.《Dissecting the pathological effects of human Abeta40 and Abeta42 in Drosophila: a potential model for Alzheimer's disease》.

2.Xuecai Ge, Frances Hannan, Zuolei Xie, Chunhua Feng, Tim Tully, Haimeng Zhou, Zuoping Xie, Yi Zhong.《Notch signaling in Drosophila long-term memory formation》.

3.Yisheng Lu, Yubing Lv, Yihong Ye, Yalin Wang, Yu Hong, Mark E Fortini, Yi Zhong, Zuoping Xie.《A role for presenilin in post-stress regulation: effects of presenilin mutations on Ca²⁺ currents in Drosophila》.