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03
2021-12

Biotheus' Bifunctional Therapeutic PM8001 has been Approved by the USFDA to Enter Phase II Studies

Time of issue: : 2021-12--03
Biotheus Inc., has announced that its proprietary anti-PD-L1/TGF-β bifunctional therapeutic, named PM8001, has been approved by the USFDA (United States Food and Drug Administration) for conducting clinical phase II studies as part of an international multicenter clinical trial. PM8001 enhances anti-tumor immune responses by blocking PD-L1/PD-1-mediated checkpoint signals and neutralizes TGF-β in the tumor microenvironment. PM8001 has a smaller size than a conventional antibody (~110 kDa) that could potentially improve its tumor penetration efficiency and is also depleted of its Fc-related effector function to mitigate any potential off-target effects. PM8001 was approved for phase I clinical studies by the Chinese NMPA in March 2020. The results from this phase I study show that PM8001 is safe and well tolerated by patients. Tumor shrinkage has also been observed on a variety of advanced solid tumors. The current plans are to investigate these exciting observations further as a single agent and in combination studies. This positive phase I data was used for the subsequent application and approval of phase II clinical studies that will be conducted in China and the US. This is a critical development milestone for Biotheus, for the development of their proprietary assets, and to foster important collaborations with experts from around the world. Mr. Liu Xiaolin, Chairman and CEO of Biotheus, stated: "PM8001 is the first anti-tumor bifunctional therapeutic asset that we have invested substantial resources to advance forward. The successful approval from the (US)FDA is both a recognition and encouragement for our team's efforts and preliminary clinical data. Biotheus has started to implement a strategic pathway to globalize our product pipeline. We are excited for PM8001 and looking forward to promote our other upcoming assets on the global stage". About Biotheus Inc. Biotheus Inc. is a biotechnology company based in Zhuhai, Guangdong, China with multiple clinical-stage assets under clinical development. Biotheus' management team has broad experience from drug discovery to NDA filing in the US and China and is developing a broad me-better/novel target pipeline focused on immuno-oncology and inflammatory diseases. While aiming to develop their leading assets towards market authorization, Biotheus is actively looking for late-stage clinical and commercialization partners to deliver their next-generation therapeutics to patients worldwide.
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15
2021-06

Biotheus and iCamuno Reached a Strategic Collaboration to Jointly Develop Two iPSC-CAB-NK Cell Therapy Products

Time of issue: : 2021-06--15
 Biotheus recently announced to have reached global strategic collaboration with iCamuno Biotherapeutis (Suhou) Co., Ltd. (iCamuno). With iCamuno’s iPSC NK cell therapy technology and Biotheus’s preclinical and clinical R&D capabilities, both parties will work together to develop two iPSC-CAB-NK cell therapy products for treating multiple solid tumors. Biotheus devotes in developing innovative biological drugs in the field of tumor immunotherapy. Its “CAB” structural cell therapy platform, with independent intellectual property rights, has notable results in treating tumors. iCamuno owns many key technologies in the iPSC cell therapy field, and has built an effective iPSC cell platform to provide patients with efficient, safe and affordable cell therapy through targeted intelligent modification to make iPSC-sourced NK cells more powerful in killing tumors. iCamuno’s tech advantage in iPSC field highly aligns with Biotheus’ industry advantage in tumor immunotherapy field. With this collaboration, both parties will advance the development of the project in the hope of providing new treatment for patients. About Biotheus Biotheus was incorporated in 2018 and it 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 autoimmune diseases while dedicating to the R&D and industrialization of the national category Ⅰ innovative biological drugs. Since establishment, the company has constructed a product pipeline of over 10 monoclonal antibody and bispecific antibody national category Ⅰ innovative biological drugs, of which 3 anti-tumor new drugs are under I-II phase clinical research, and a forth one has been submitted for clinical trials in May 2021. Biotheus will continue to put more into R&D and more new drugs are expected to enter clinical phase by the end of 2021.  About iCamuno  iCamuno is a biotech company focusing on iPSC cell therapy platform building and multiple universal cellular therapies. Its founding team has profound technical accumulation in iPSC, gene editing, stem cell differentiation and other cutting-edge fields and owns many independent intellectual property rights. The relevant achievements of the core founding team have been widely reported and commented by official media at home and abroad, such as Science and Technology Daily, XinhuaNet, ScienceNet, China News, Los Angeles Times and so on. With its leadership, iCamuno has developed rapidly and established a team with rich experience in operation management, pipeline R & D, clinical research, industrialization and other fields. At present, the company has various independent R & D pipelines and has cooperated with many other companies to actively promote the clinical application of universal cellular therapy.
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03
2021-03

Biotheus Announces the Closing of a New Round of Financing co-led by General Atlantic and IDG Capital

Time of issue: : 2021-03--03
ZHUHAI, China, March 2, 2021 /PRNewswire/ -- Biotheus has announced the successful completion of a fourth round of financing, co-led by General Atlantic, a leading global growth equity investor, and IDG Capital, a global leading investment firm. Other new investors include Kunlun Capital, CPE, and Cowin Capital, with participation by previous investors Highlight Capital, Shiyu Capital, New Alliance Capital, Huajin Investment, and others. Founded in 2018, Biotheus is a clinical development stage company with the mission of treating cancer and autoimmune diseases through next-generation therapeutics. This is supported by the company's product pipeline, which consists of over 10 novel monoclonal and multispecific antibodies. Biotheus currently has two bispecific antibodies in phase I clinical development for cancer treatment, and a third IND application was submitted at the end of 2020. With this new investment, Biotheus will further increase its investment into its research activities with the aim to have five novel drugs into clinical development by the end of 2021, and drive multiple programs into late-stage clinical development. Regarding this round of financing, Mr. Xiaolin Liu, President and CEO of Biotheus, remarked: "we are pleased that our efforts have been recognized and supported by leading investors like General Atlantic and IDG Capital. The continued support from our previous investors is also testament to our company's progress, execution and the strength of our pipeline. This round of financing will fund the development of our existing product pipeline and the construction of our manufacturing facility. With the strong support of all our investors, we will fully drive the development of our product pipeline, strengthen our position in the global market for cancer immunotherapy, and bring much-needed innovative treatments and options to a larger population of cancer patients." Mr. Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic, added: "In a short period of time, Biotheus has developed a differentiated and competitive pipeline of next-generation therapies, underpinned by an efficient R&D engine and a premier founding team with a successful track record of antibody development. Taken together, we believe that Biotheus is strongly positioned as an emerging player in the global biopharmaceutical landscape. We look forward to supporting Biotheus and its leadership team to accelerate the development of their deep product pipeline and advance innovative, life-saving cancer treatments to the commercial stage." "Led by Mr. Xiaolin Liu, the core team of Biotheus has extensive experience in the development of novel antibody drugs," said Mr. Tao Huang, Vice President of IDG Capital. "Biotheus has built multiple platforms critical for drug development and a product pipeline with a strong competitive advantage. The construction of their manufacturing base has also begun. We believe Biotheus has significant growth potential." About Biotheus Founded in 2018, Biotheus is an up-and-coming biotech company focused on curing malignant tumors and autoimmune diseases. Biotheus is committed to research and development, and commercialization of first-class innovative biologics mainly through the discovery of next-generation multispecific antibodies. Biotheus has completed four rounds of financing. In addition, Biotheus has received support from the Zhuhai government through a number of initiatives and policies that drive local innovation. About General Atlantic General Atlantic is a leading global growth equity firm providing capital and strategic support for growth companies. Established in 1980, General Atlantic combines a collaborative global approach, sector specific expertise, a long-term investment horizon and a deep understanding of growth drivers to partner with great entrepreneurs and management teams to build market-leading businesses worldwide. General Atlantic has more than 175 investment professionals based in New York, Amsterdam, Beijing, Greenwich, Hong Kong, Jakarta, London, Mexico City, Mumbai, Munich, Palo Alto, São Paulo, Shanghai and Singapore. For more information on General Atlantic, please visit the website: www.generalatlantic.com. About IDG Capital Started from 1993, IDG Capital was the first firm to bring foreign venture capital into China. IDG Capital has always been pursuing long-term value investing and focused on developing extraordinary companies through our expertise in private equity and venture capital. After nearly 30 years of development, IDG capital has accumulated asset under management of about 150 billion RMB, invested more than 1,000 companies and with over 200 successful exits. IDG Capital focuses on leading companies in the fields of TMT, new consumer and service, entertainment, healthcare, advanced manufacturing and clean energy, with companies expanding from early stage to growth stage, IPO and M&A. IDG Capital investment portfolio
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