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15
2022-11

Biotheus has entered into a license and collaboration agreement with Hansoh Pharma for its EGFR/MET bispecific antibody in the Greater China territory

Time of issue: : 2022-11--15
Zhuhai, China, November 14, 2022 (PR NEWSWIRE) --- Biotheus Inc., a clinical-stage biotech company focused on the discovery and development of biologics for oncology and inflammatory diseases, announced today that they have entered into a collaboration agreement with Hansoh Pharmaceuticals, for Biotheus’ EGFR/MET bispecific antibody (also known as PM1080) in Greater China, including Mainland China, Hong Kong, Macao and Taiwan. Under the terms of the agreement, Hansoh will be granted by Biotheus the exclusive rights to develop, commercialize and manufacture PM1080 for the treatment of cancer, and shall assume all the costs accordingly in the territory. In return, Biotheus will receive 50 million CNY and is entitled to receive up to ~1.4 billion CNY for future development, regulatory and commercialization milestones, plus tiered royalty payments based on net sales. “We are delighted to enter into a partnership with Biotheus.” Said Ms. Yun Sun, Managing Director of the Board at Hansoh. “EGFR/MET bispecific antibodies are an instrumental therapeutic option for non-small cell lung cancer and other cancer indications; PM1080, based on its outstanding efficacy, safety and PK profiles in preclinical studies, has best-in-class potential for treating cancer, either alone or in combination with Hansoh’s almonertinib. Through this partnership, we believe that we will bring forth rapidly a better therapeutic option to Chinese cancer patients, by utilizing our rich experience and capabilities in the development and commercialization of oncological drugs.” “We really appreciate Hansoh’s trust and confidence in us.”, said Xiaolin Liu, Co-founder, Chairman and Chief Executive Officer of Biotheus. “Hansoh is one of the leading oncology pharmaceutical companies in China and this collaboration spurs the synergy between Hansoh’s strong development and commercialization capabilities with our rich R&D expertise at Biotheus. The partnership will expedite the development and commercialization of PM1080 in Greater China. Biotheus has robust R&D platforms with 10 programs currently undergoing phase I or II clinical development. We are proud of our current accomplishments within four years of founding Biotheus and will continue our commitment to discover innovative drugs to benefit patients.” About PM1080 PM1080 is an EGFR/MET bispecific antibody under development at Biotheus, who owns global rights to the asset. PM1080 is currently undergoing GLP toxicity studies. Previous preclinical data has shown that PM1080 is safe and efficacious, either alone or in combination with other anti-cancer agents, including EGFR TKIs. About Biotheus Inc. Biotheus Inc. is a clinical-stage biotech company established in 2018 and is committed to the development and commercialization of novel antibodies and cell therapies, to address the unmet medical needs of patients with oncology and inflammatory diseases worldwide. Since its inception, Biotheus has established multiple top-caliber platforms for antibody discovery and a propriety cell therapy that delivers T cell engagers into the tumor microenvironment to destroy tumor cells. With a well-seasoned development team, Biotheus has built up a robust pipeline inclusive of 10 programs at different stages of clinical development. For more information about Biotheus, please visit: www.biotheus.com. About Hansoh Pharmaceuticals Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 10,000 dedicated employees in China and the United States. Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions in oncology, central nervous system (CNS) disorders, infectious diseases, gastrointestinal disorders, diabetes, autoimmune diseases, and other main therapeutic areas in China. With the support of over 1,400 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including Morinidazole (Mailingda, 迈灵达), a third-generation nitroimidazole antibiotic; PEG-Loxenatide (Fulaimei, 孚来美), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes; Flumatinib (Xinfu, 昕福), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML); Almonertinib (Ameile, 阿美乐), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations; and Tenofovir Amibufenamide (恒沐), the first second-generation oral anti-HBV drug developed in China. Through collaboration and partnership, NMPA has granted approval to Inebilizumab (Xinyue, 昕越), a humanized anti-CD19 monoclonal antibody, as a treatment for patients with neuromyelitis optica spectrum disorder (
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15
2022-04

Biotheus Shares Latest Research & Development Updates on Multiple Programs During AACR, 2022 and SITC, 2021

Time of issue: : 2022-04--15
Biotheus Inc., participated at the 113th Annual Meeting of the American Association of Cancer Research, 2022, sharing six posters including four bispecifics: PM1022 (PD-L1 x TIGIT), PM1009 (TIGIT x PVRIG), PM4008 (CEACAM5&6 x CD3) and PM1032 (CLDN18.2 x 4-1BB); and two other monoclonal antibodies: PM1038 (CD39) and PM1015 (CD73). Biotheus also previously presented at the Annual SITC meeting in 2021 on programs PM1003 (PD-L1/4-1BB) and their novel CAB-T cell therapy platform. Details of these programs are below.   AACR2022 PM1022 (PD-L1 x TIGIT): https://www.abstractsonline.com/pp8/#!/10517/presentation/17744 PM1009 (TIGIT x PVRIG): https://www.abstractsonline.com/pp8/#!/10517/presentation/17746 PM4008 (CEACAM5&6 x CD3): https://www.abstractsonline.com/pp8/#!/10517/presentation/17774 PM1032 (CLDN18.2 x 4-1BB): https://www.abstractsonline.com/pp8/#!/10517/presentation/17775 PM1015 (CD73): https://www.abstractsonline.com/pp8/#!/10517/presentation/18034 PM1038 (CD39): https://www.abstractsonline.com/pp8/#!/10517/presentation/17747 SITC2021 PM1003: http://dx.doi.org/10.1136/jitc-2021-SITC2021.895 CAB-T platform: http://dx.doi.org/10.1136/jitc-2021-SITC2021.206   BD enquiries and supplemental material requests Please contact du.yl@biotheus.com or tsun.a@biotheus.com for partnering opportunities and high-resolution PDFs of these posters.   About Biotheus Founded in 2018, Biotheus focuses on the research and development of next generation multispecific antibodies for oncology and inflammatory diseases. As a clinical-stage biotech company, Biotheus currently has two programs at phase II clinical development and a further six programs at phase I. For more information, please visit www.biotheus.com.   PM1022 (PD-L1 x TIGIT): AACR2022 Abstract #5525 BACKGROUND: TIGIT (T-cell immunoglobulin and ITIM domain), which is primarily expressed on activated and 'exhausted' T and NK cells, is one of the most promising 'next generation' immune checkpoint target. Engagement of TIGIT to its ligands (i.e., PVR and PVRL2) leads to inhibitory signaling in T cells and promotes the functional exhaustion of tumor-infiltrating T lymphocytes. Anti-TIGIT monoclonal antibodies have shown clinical benefit when combined with anti-PD-L1 agents in NSCLC. Here, we describe our novel anti-PD-L1 × TIGIT bispecific antibody (PD-L1 × TIGIT biAb) that blocks both the PD-L1/PD-1 and TIGIT/PVR/PVRL2 pathways and has the potential to exhibit equal clinical benefit compared to current combination therapies. RESULTS: The PD-L1 × TIGIT biAb binds with high affinity to the extracellular domain of human TIGIT and PD-L1 and can bind to TIGIT and PD-L1 simultaneously. In a competition assay, the PD-L1 × TIGIT biAb efficiently blocked the interaction between TIGIT and PVR/PVRRL2, and likewise PD-L1 to PD-1. The PD-L1 × TIGIT biAb induced higher luciferase signals than the anti-TIGIT or anti-PD-L1 mAbs alone in a luciferase reporter-based cell system and enhanced IFN-γ production in an MLR assay. In vivo, the PD-L1 × TIGIT biAb demonstrates similar anti-tumor efficacy to the combination of anti-TIGIT and anti-PD-L1 mAbs, which is stronger than the single-agents alone. We have also completed GLP-toxicity studies that have shown excellent safety. CONCLUSIONS: We have discovered a novel PD-L1 × TIGIT biAb, which induces strong immune responses in vitro and in vivo, supporting its clinical development for the treatment of human cancers. Clinical trials shall be initiating in early 2022. PM1009 (TIGIT x PVRIG): AACR2022 Abstract #5527 BACKGROUND: TIGIT (T-cell immunoglobulin and ITIM domain), which is primarily expressed on activated and 'exhausted' T and NK cells, is one of the promising 'next generation' immune checkpoint molecules. Engagement of TIGIT to its ligands (i.e., PVR and PVRL2) leads to inhibitory signaling in T cells, promoting functional exhaustion of tumor-infiltrating T lymphocytes. Anti-TIGIT monoclonal antibodies have shown clinical benefit when combined with anti-PD-L1 agents in NSCLC. However, the single-agent efficacy of anti-TIGIT therapies have been limited. PVRIG (PVR-related immunoglobulin domain containing), which is another coinhibitory receptor of the DNAM/TIGIT/CD96 nectin family, binds with high affinity to PVRL2 and suppresses T-cell function, and shows nonredundant inhibitory effects alongside the TIGIT/PVR/PVRL2 axis. Here, we report a fully-human anti-TIGIT × PVRIG bispecific antibody (anti-TIGIT × PVRIG biAb), which blocks both the PVRIG/PVRL2 and TIGIT/PVR/PVRL2 pathways, that maintains the efficacy of the combination of the two mono-agents. The anti-TIGIT × PVRIG biAb is also highly efficacious when combined with PD1/PD-L1 inhibitors in mouse tumor models. RESULTS: The anti-TIGIT × PVRIG biAb binds with high affinity to the extracellular domain of human TIGIT/PVRIG and can bind to TIGIT and PVRIG simultaneously. In a competition assay, the anti-TIGIT × PVRIG biAb efficiently blocked the interaction betwee
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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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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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