Efficient R&D Platform and Strong R&D Strength
The Company is dedicated to finding solutions to treat tumors and immunological diseases. It is generally known that it takes years to develop a new drug. However, the Company has over 20 drug development programs developed in-house though it has been established for only eight years. These programs include 12 antibodies in clinical-stage development, six bi-specific antibodies (two of which are at the clinical stage), and four antibodies with IND approvals from the Food and Drug Administration (FDA). Its product pipelines cover several major diseases, such as tumors, immunological diseases, and cardiovascular diseases. It is worth mentioning that the Company has developed all its programs in-house. In November 2015, the Company became the first China-based biotech company to out-license a fully internally discovered monoclonal antibody to a world-leading pharmaceutical company as it out-licensed its CTLA-4 monoclonal antibody drug candidate (AK107) to Merck for a total consideration of up to USD200 million.
The Company’s strong R&D capability is indispensable from its end-to-end ACE Platform that possesses comprehensive, the most cutting-edge functionalities in developing therapeutic antibodies. The ACE Platform encompasses drug development and manufacturing and enables seamless technology transfer from drug discovery and CMC to manufacturing. Moreover, it holds strong internal manufacturing capacity that is compliant with GMP standards regulated by the NMPA, FDA and EMA. All drugs in the clinical stage are produced in the Company’s proprietary facilities in line with GMP standards.
Prominent Advantages of Core Products, Favored by the Capital Market
The key to biopharmaceutical success lies in R&D strength and efficiency. The player who takes the lead to develop a drug and obtain approval for launch, and who can prove commercialization capabilities will gain competitive edges.
The Company has developed industry-leading drugs with the ACE Platform including its core products: PD-1/CTLA-4 bi-specific antibody (AK104) and PD-1 monoclonal antibody drug, Penpulimab (AK105). Its products also encompass AK101, a promising monoclonal antibody against autoimmune diseases, and AK102 that has high potential to become the first cardiovascular drug candidate against PCSK9 developed in China.
The Company has led the world in terms of the R&D of bi-specific antibodies. Bi-specific antibodies are deemed as a second-generation antibody therapy against tumors. With respect to the research on bi-specific antibodies, the Company possesses the unique bifunctional antibody technology, Tetrabody, making it one of the few bi-specific antibody platforms verified in both manufacturing and clinical stage. According to clinical observation, compared with the combined therapy of Nivolumab and Ipilimumab, AK104 has demonstrated better safety and efficacy. As of September 30, 2019, over 90 bi-specific antibodies were undergoing clinic trial. Nevertheless, no PD-(L)-based bi-specific antibodies had been approved for market launch. AK104 is the world’s first bi-specific antibody drug that is in the clinical trial stage. It is expected that the first new drug application (NDA) of AK104 of the Company for treating cervical cancer will result in first-mover advantage.
AK105 of the Company is a monoclonal antibody currently in late-stage clinical development. PD-1 monoclonal antibody drugs are experiencing fierce competition, as six PD-1 drugs have been launched in China. Despite the extensively competitive market, AK105 is still favored for its strong efficacy and high safety. Therefore, Sino Biopharmaceutical Limited, a HK-listed pharmaceutical leader, has cooperated with the Company to jointly develop and commercialize AK105. AK105 of the Company is the only PD-1 antibody that Sino Biopharm can use to develop PD-1-based monotherapy or combination therapy, which evidences the great commercial potential of AK105. After the new drug is launched, the wide online sale channels and immense commercial capability of Sino Biopharmaceutical Limited will be utilized by the Company to maximize the commercial value of AK105.
Thanks to its strong R&D strength and commercialization capabilities, the Company has been favored by the capital market. Through Series D financing in November last year, the Company raised USD126 million in total, with the leading investor being Sino Biopharmaceutical Limited. Medical funds like Lake Bleu Capital, OrbiMed, and AIHC Capital participated in the financing. The Company’s valuation reached USD836 million after Series D financing and became nearly 18 times as high as that after Series A financing of RMB330 million in just four years. Especially, Shenzhen Capital Group Co., Ltd. (SCGC), a leading venture capital firm in China that was co-founded by the Shenzhen Municipal Government and a group of private partners, participated in every series of financing. Relevant funds under K. Wah Group became a shareholder of Akeso in the series of financing before the IPO. This also means that K. Wah Group has set foot in the healthcare sector. Investment from famous capital holders reflect Akeso’s bright future.
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