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20
2020-10

Biotheus and Kintor Reached a Strategic Cooperation Agreement on the Development of Biological Drugs

Time of issue: : 2020-10--20
Biotheus recently announced to have reached a strategic collaboration agreement on biological drugs development with Kintor Pharmaceutical Limited (Kintor). Through the collaboration, both parties will work together to give full play to their respective advantages, and promote and expand each other’s biological drugs development strategy to build a solid foundation for future more in-depth cooperation. Mr. Liu Xiaolin, the founder and Chairman of Biotheus said, “We are very delighted to have entered into the strategic cooperation agreement with Kintor Pharmaceutical. We thank Kintor Pharmaceutical for their confidence and recognition to our innovative drugs, R&D team as well as technology platform. We will explore the development and clinical strategies of biological drugs with Kintor Pharmaceutical in order to identify better solutions.” Dr. Tong Youzhi, the founder, Chairman and CEO of Kintor Pharmaceutical indicated, “Biotheus maintains a leading position in terms of the experience in large molecules industry. The cooperation between Kintor Pharmaceutical and Biotheus will boost the R&D and expansion of antibody drug for our company, and it is also beneficial to the exploration of more comprehensive treatments during the clinical phase, which will help our company step into a new stage that enables the thriving for both small molecules and large molecules of Kintor Pharmaceutical.” About Biotheus  Biotheus was incorporated in July 2018 with a registered capital of USD 75 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 drugs. Since the establishment of Biotheus, three rounds of financing have been completed. Meanwhile, it has entered into a cooperation agreement with Zhuhai Gaoxin District government and received several supporting measures from the government, and it was also awarded as Zhuhai Unicorn Enterprise (potential enterprise), China Nezha Enterprise 2019, and China 50 Most Innovative Biopharmaceutical Companies 2019. Biotheus has constructed a product pipeline of over 10 national innovative biological drugs, of which 2 new antibody drugs have been approved for clinical trial. According to product development plan, 5 new antibody drugs will successively enter clinical research phase by the end of 2021. About Kintor Founded in 2009, Kintor concentrates on the R&D and industrialization 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, after years of development, has 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, bio-innovative drugs and combination therapies, including 5 products that are undergoing clinical research, such as androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog/SMO inhibitors, as well as PD-L1/TGF-β dual-targeting antibody, AR-Degrader and c-Myc inhibitors that are undergoing preclinical research. Globally, the Company has more than 60 patents obtained or under review, many of which are listed as the “Major New Drugs Discovery” in National 12th and 13th Five-Year Plans. On May 22, 2020, the Company was officially listed on the Hong Kong Stock Exchange with the stock code 9939.HK.
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15
2020-10

Biotheus and Shanghai East Hospital Reached a Strategic Cooperation to Jointly Carry Out Clinical Research on Innovative Anti-tumor Drugs

Time of issue: : 2020-10--15
On October 14, 2020, the signing ceremony of strategic collaboration between Biotheus and Shanghai East Hospital was held in Shanghai. Attending the signing ceremony were Liu Zhongmin, president of Shanghai East Hospital, Professor Li Jin, director of Department of Oncology, Professor Guo Ye, director of Phase I Clinical Trial Center, Shi Yan, director of Clinical Trial Institution Office, Zhang Min, director of South Texas Accelerated Research Therapeutics(START) (Shanghai) , Mr. Liu Xiaolin, president of Biotheus, Mr. Hu Guoqiang, Biotheus’ chief medical officer, Professor Li Bin, chairman of Scientific Committee, as well as representatives of investors. According to the collaboration agreement, Biotheus and Shanghai East Hospital will integrate their respective advantageous resources, carry out in-depth cooperation in the clinical research of multiple anti-tumor innovative drugs, realize resource exchange and complement each others’ strength, accelerate the development of new anti-tumor drugs, and bring the drugs with excellent curative effect and high quality to the market as soon as possible, benefiting the majority of cancer patients in China and even in the world. At the signing ceremony, Professor Li Jin first delivered a speech on behalf of the hospital and expressed his gratitude for the convening of the signing ceremony and Biotheus’ affirmation of the clinical trial experience of Shanghai East Hospital. He also stated, “The R&D of new anti-tumor drugs has always been a hot topic in clinical research. With recent discovery of new technologies and new targets, more and more innovative drugs have entered into clinic trials. Despite all that, the field still faces the common problems of high development risk and low R&D efficiency. Only with the joint cooperation of hospitals and pharmaceutical enterprises can it accelerate the development process and timely screen out more successful potential drugs that are able to resolve the burden of major diseases. We understand that the core team of Biotheus has abundant experience in the field of tumor immunotherapy. We look forward to working with Biotheus R&D team to promote the clinical research of new drugs quickly, efficiently, scientifically and rigorously, and further improve the clinical research level of Shanghai East Hospital to achieve win-win results for both sides.” Mr. Liu Xiaolin, CEO of Biotheus, delivered a speech on behalf of the company, saying, “Clinical research is a phase with the longest investment cycle and the largest capital in the whole process of new drug development. As an innovative drug company focusing on the field of cancer, Biotheus will have a wide range of candidate products successively promoted to the clinical research phase. Therefore, we have set up a clinical research center in Shanghai and actively seek cooperation with professional and authoritative clinical research institutions and teams. Shanghai East Hospital has a domestic first-class technical expert team with rich experience in the early clinical research of new anti-tumor drugs. We are honored to cooperate with such an excellent team. We hope that both sides will work together in the future to bring more products with excellent curative effect and high quality to the patients as soon as possible.” Mr. Hu Guoqiang, CMO of Biotheus, introduced the company’s product pipeline. At present, the R&D pipeline has covered the fields of bispecific antibody, oncolytic virus and cell therapy. The first bispecific antibody anti-tumor target new drug (PM8001) is carrying out phase I clinical research and is progressing smoothly. It is expected that 5 anti-tumor biological drugs will enter into the clinical research phase by 2021. Professor Guo Ye from Shanghai East Hospital introduced in details about the situation in START-East Clinical Phase I Trial Center of New Drugs, which has become one of the largest phase I clinical trial centers for new drugs R&D in China. Since its establishment of three years, more than 70 projects have been taken and carried out, covering new therapeutic methods such as immune checkpoint inhibitors, cell therapy and targeted therapy. The center has accumulated rich experience in the early clinical research of new anti-tumor drugs. President Liu Zhongmin fully affirmed the significance of this strategic collaboration, and put forward higher expectations and requirements for Biotheus and the oncology department of the hospital. He looked forward to closer cooperation between the two sides in new drug R&D and academic exchanges, not only developing domestic and even international leading anti-tumor drugs, but also bringing new models of R&D and application, new economic growth points as well as new business model through innovation. About Biotheus Incorporated in 2018, Biotheus has carried on its start-up vision “to inspire each other and create effective drugs for humankind”, focusing on malignant tumors and metabolic disease
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29
2020-06

Biotheus Announces the Completion of the Third Round of Financing

Time of issue: : 2020-06--29
Recently, Biotheus announced the successful completion of a third round of financing. This round of financing is jointly funded by leading investor New Alliance Capital, new investors HANNE Capital, etc., and original investors Highlight Capital, Shiyu Capital and HuaJin Capital. Since its establishment in 2018, Biotheus has constructed a product portfolio of over 10 monoclonal antibody and biospecific antibody categoryⅠinnovative biological drugs, covering treatment fields of tumors and metabolic diseases. The first bispecific antibody new drug (PM8001) has been approved and is under phase I clinical research. 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. It is expected to provide brand new clinical solutions for cancer patients after market launched in the future. According to the product chain development plan, 5 innovative drugs are expected to enter clinical research phase by the end of 2021. At the same time, in the process of product chain development, Biotheus will also actively seek strategic cooperation in many aspects to quickly advance the process of new drug development. "Over the past two years, with the support of investors and local governments and the joint efforts of the team, Biotheus has made smooth progress in product development, improvement of R&D facilities and team construction, and successfully completed all set goals." Mr. Liu Xiaolin, President of Biotheus, said, "I'm glad that the achievements and development potential of the company have been recognized by new investors such as New Alliance Capital. We have completed three rounds of financing. This is the largest one, and all the funds obtained will be used to support the development of new drugs and enterprise operation of the company." Mr. Wu Zonghe, partner of New Alliance Capital indicated: "Just two years after its establishment, Biotheus has emerged in the domestic biomedical industry and developed very rapidly. We recognize Biotheus’ corporate philosophy and future development plan, and hope that our participation can help Biotheus quickly promote the development progress of innovative drug product portfolio, strive for the early launching of new drugs and benefit the majority of patients." Ms. Jiang Yanye, spokesman of Highlight Capital stated: "Since the start of Biotheus, we have been paying attention to the company and supporting the development of it. We are very happy and gratified to see the achievements made by Biotheus in the past two years. In the future, we will continue to spare no effort to provide support and help and grow together with Biotheus." About Biotheus Biotheus was incorporated in 2018 and has carried on its start-up vision “to inspire each other and create effective drugs for humankind”, as well as focused 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). About New Alliance Capital Founded in 2008, New Alliance Capital is a fund management company focusing on private equity and venture capital. It manages a number of funds with total assets of more than 10 billion RMB. Its main investors include well-known state-owned enterprise groups, professional master funds, government guidance funds and listed companies. The main investment directions of New Alliance Capital include science and technology / media, medical and health fields, covering early phase, growth phase, mature phase and other phases. So far, more than 70 investments have been completed, including more than 20 IPO / listing enterprises at home and abroad, and a number of industry leaders have been cultivated.
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16
2020-03

Biotheus and TILT Biotherapeutics Reached a Strategic Cooperation

Time of issue: : 2020-03--16
Biotheus recently announced to have reached strategic collaboration agreement with Finland’s TILT Biotherapeutics Ltd (TILT). According to the agreement, Biotheus will have the right to develop and commercialize of oncolytic virus TILT-123 authorized by TILT in the Greater China area (including Mainland China, Hong Kong, Taiwan and Macao). TILT ® Technology is a new oncolytic virus developed based on sufficient research foundation of adenovirus which has unique characteristics and functions, and has comprehensive patent protection. TILT-123 is a human 5 / 3 chimeric adenovirus, which can only selectively replicate in most human tumor cells and play a role in oncolysis. In addition, the local expression of cytokines with immunomodulatory effect in tumor is expected to further improve the effect of anti-tumor therapy without increasing toxic effect and side effects. Akseli Hemminki, MD, founder and CEO of TILT, said: "We are pleased to hand over our flagship product TILT-123 to Biotheus experts. TILT-123 is a unique product developed to activate T cells. At present, clinical development is about to be carried out in Europe and the United States. Biotheus team has rich experience in tumor immunotherapy and we believe that this cooperation will greatly support the global development and commercialization of TILT-123 and benefit cancer patients in China. " Mr. Liu Xiaolin, founder and President of Biotheus, expressed: "We’re glad to cooperate with TILT and we thank TILT for its affirmation of our R& D ability. The introduction of TILT-123 project has well enriched our product pipeline in anti-tumor drugs. At present, the project is beginning the preparation of clinical application, and clinical trial application is expected to be submitted before the end of this year." About TILT Founded in 2013, TILT is a biopharmaceutical company specialized in the development of oncolytic adenovirus in Helsinki, Finland. Many oncolytic viruses developed by the company have been used in clinical trials as advanced therapeutic products. In 2019, the company announced that it had reached an agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the application value of its new generation oncolytic virus TILT-123 combined with anti-PD-L1 monoclonal antibody avelumab in routine treatment of refractory solid tumors. Tilt-123 is currently in phase I clinical trial in Denmark.
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09
2020-03

Clinical Trial Notification of Dual Biospecific Antibody PM8001

Time of issue: : 2020-03--09
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.
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