• Categories:2020
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• Time of issue:2020-03-09
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(Summary description)Biotheus is a national first-class innovative biopharmaceutical company dedicated to the field of malignant tumors and metabolic diseases. The company officially announced today that its bispecific monoclonal antibody (Project No.: PM8001) against two tumor related targets, including programmed death ligand 1 (PD-L1), has recently obtained the notification of drug clinical trial issued by the National Medical Products Administration (NMPA), and plans to carry out clinical research on advanced tumors such as lung cancer.

PD-1 / PD-L1 inhibitory monoclonal antibodies are the focus of tumor immunotherapy in recent years. PD-1/PD-L1 inhibitors currently on the market include: PD-1 inhibitors: Opdivo and Keytruda, which are used in the treatment of various cancers such as melanoma and non-small cell lung cancer; many domestic snti-PD-1drugs from Shanghai Junshi Biosciences Co., Ltd., Innovent Academy, Hengrui Pharmaceutical, and etc, have also been approved for market launching in the near future. PD-L1 inhibitors, including Tecentriq, Bavencio and Imfinzi, have been approved for failed cisplatin treatment, or progressing advanced bladder cancer, advanced or metastatic urethral epithelial carcinoma and metastatic Merkel cell carcinoma. However, at present, anti-PD-1 / PD-L1 monoclonal antibody single drug and combination therapy for solid tumors are only effective for certain cancer patients.

PM8001 is based on single domain antibody with small molecular weight and good stability, it targets two tumor related targets including PD-L1 at the same time, so as to improve the anti-tumor activity and curative effect. The approval of PM8001 for drug clinical trial issued by NMPA marks that Biotheus has made significant progress in the innovative research and development in the field of tumor immunotherapy, and the company is expected to provide new clinical solutions for patients in the future.

Mr. Liu Xiaolin, founder and CEO of Biotheus stated: "PM8001 is the first bispecific antibody in a number of anti-tumor projects under development by Biotheus, and it is also the first new drug project we promote with full effort. Our core team has rich experience in the field of tumor immunotherapy. At the same time, we have built core technology platforms in antibody discovery, antibody engineering transformation, target discovery, preclinical and CMC research. Experienced teams and advanced platform technology are the keys to the rapid and successful approval of PM8001. The successful approval of clinical research for this project is an affirmation and encouragement of Biotheus’ innovation ability and R&D level. In the following steps, we will start phase I clinical research as quickly as we can, and hope to develop and market the product as soon as possible to benefit the majority of patients. " 

About Biotheus

Biotheus was incorporated in 2018 with a registered capital of USD25 million. Biotheus has carried on its start-up vision “to inspire each other and create effective drugs for humankind”, focusing on malignant tumors and metabolic diseases while dedicating to the R&D and industrialization of the national category I innovative biological drugs, prioritizing the R&D of a new generation dual targeting antibody drug. Since the establishment of Biotheus, three rounds of financing have been completed. Meanwhile, it entered into a cooperation agreement with Zhuhai Gaoxin District Government and received several supporting measures from the Gaoxin District Government as a result, while being recognized as Zhuhai Unicorn Enterprise (potential enterprise).

Biotheus is now pushing on over ten national category I biological new drug projects which include monoclonal antibody and bispecific antibody. In the next three to five years, the focus will be conducting R&D on a bispecific antibody new drug based on the new generation of tumor immune treatments. Concurrently, Biotheus has built core technology platforms for different sectors, including discovery of antibodies, antibody construction renovation, target discovery, preclinical and CMC research, which could support an effective and high-quality completion of the antibody new drug project, from the discovery of antibody to clinical reporting.

The core team of Biotheus has rich experience in the development and industrialization of high-end biological new drugs for more than 20 years on average. It has engaged in new drug R&D and management in many well-known biopharmaceutical companies at home and abroad, including Abbott, Bristol-Myers Squibb, Novartis, Innovent and so on. It has participated in more than 40 new drug R&D projects, and the total annual sales of listed varieties has exceeded US $20 billion. The experienced core team will promote the successful implementation of new drug projects.