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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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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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Xiaoniu Miao, Director Antibody R&D of Biotheus:R&D of Antineoplastic New Drugs Accelerated by over USD100 million Financing

Time of issue: : 2021-05--19
导读:在国内已有6款上市PD-1单抗药物的情况下,还有近80个国产PD-1正处于研发阶段。我们该如何看待抗体药物同质化竞争的现状?缪小牛认为需要差异化竞争,这也是普米斯生物聚焦双特异性抗体和纳米抗体的原因。 抗体药物时代,超过100款抗体药物获FDA批准上市  近年来,在FDA每年批准的新药中,抗体药物占据了1/5的份额,至今已有超过100款抗体药物获得FDA上市批准。随着抗体技术得到不断更新,基于最开始的单克隆抗体衍生出ADC、双抗、抗体片段、以及纳米抗体等越来越多的抗体药物。相较于典型的单抗,ADC、双抗等类型的抗体药物发展历史更短一些,目前获得美国FDA批准的只有2款双抗和11款ADC药物。与此同时抗体药物显示出了强大的收入潜力,2019年的全球销售TOP 20药物榜单中,就有9款抗体药物。据不完全统计,全球抗体药物2019年销售总额达到1592.7亿美元。2015年来,新进入临床的抗体药物中,热门靶点包括PD-1/PD-L1、HER2、CTLA-4、4-1BB、新冠、LAG-3、CD20、CD47等。  2021年3月,成立不到3年的普米斯生物技术(珠海)有限公司宣布完成新一轮逾亿美元融资。作为一家临床阶段的抗体研发公司,普米斯现有2个抗肿瘤双抗新药正在开展I期临床研究,第3个新药项目已于2021年初获得了临床试验批件,另有1个三抗新药已获临床申请受理。 缪小牛,普米斯生物抗体研发总监  近日,在由医麦客举办的BPIT 2021生物药创新技术大会上,普米斯生物抗体研发总监缪小牛分享了《纳米抗体在双特异性抗体开发中的应用》的主题报告,并做客医麦客《峰客访谈》,就普米斯生物在抗体研发上的进展,抗体研发现状及趋势进行了谈话,以下是访谈内容的整理。 完成逾亿美元融资,加速抗体产品线研发进程  “我们最近刚完成了一轮融资,用于加速我们公司现有产品线的推进,同时我们也会建立自己的生产基地,第二,除了现有产品线以外,我们会在新靶点的发现以及相关药物的开发上投入更多,真正去做first in class的分子。”谈及最近完成的该轮融资计划,缪小牛说。对于投资人看好普米斯生物的原因,缪小牛认为早期投资的进入看中的是公司团队的完整性,公司领导层的长期经验。  普米斯生物总裁刘晓林博士曾先后在美国Abbott(雅培)、Adimab等著名医药公司担任研发高管、总监等职务,曾领导抗体药伊匹木单抗(Yervoy)研发;参与全球最畅销抗体新药修美乐的工艺优化。2012年回国后,刘晓林担任信达生物高级副总裁,成功完成第一例国产PD-1单抗新药的开发上市。  “现在投资人主要看的是公司的研发管线,以及项目的推进速度,我们最快的项目已经即将进入临床二期阶段了,他们看到了项目以及公司的潜力。现在普米斯生物的两款候选分子在国际都属于比较领先的分子;我们使用的是以纳米抗体为主的双特性抗体结构,它在抗体的大小、有效性、肿瘤的渗透性方面都会比传统的双特性抗体更有一些优势,我们很看好它在临床上的表现。” 两个抗体平台  “普米斯在早期抗体发现方面主要有两个平台,一个是纳米抗体的发现的平台,就是免疫羊驼来获得纳米抗体。另外一个是人源化小鼠,来发现全人源抗体的平台。这两个平台技术都是建立在我们公司非常成熟的酵母展示技术平台基础上的,目前我们已经可以很快速地获得质量较高的纳米抗体以及全人源IgG抗体。而且我们公司会有一整套的成药性评估平台,可以在最早期就评估这个药候选分子是否有成为真正的药物的可开发性。我们有非常全面的抗体工程改造平台,包括人源化、亲和力成熟,改善成药性等。这些构成了我们早期抗体发现的平台。  除了抗体发现以外,我们公司有非常完善的CMC平台,从早期的细胞株开发到工艺开发、纯化、制剂以及分析,已经可以自己handle很多项目。在过去两年多的时间里,我们公司已经推进了两个项目进入临床阶段,另外也有项目已经获得了临床批件,将在今年进入临床阶段。而今年的话也会有多个IND申报的计划,所以我们整个的CMC的平台是非常完善,效率非常高的。  此外,我们会在南通建立一个产业化的基地,我们想自己做自己的生产,这是为以后长远来考虑的。  在商业方面我们也有一些合作。我们会寻找一些跟我们专业领域相关的,而且做的比较好的项目进行合作;同时我们自己的项目也非常欢迎有兴趣的合作伙伴来进行共同开发。我们倾向于选择评估后觉得有开发潜力的项目,我们自己有很多内部的研发项目做得非常好,我们会选择我们觉得有能力,有意愿,可以合作沟通的一些公司,在双方的利益都能够最大化的情况下进行合作。” PD-1之后是一个挑战很大机遇也很多的时代  在恒瑞医药、百济神州、君实生物、信达生物跃身为国内PD-1单抗市场的第一梯队纳入国家医保目录之时,四款国产PD-1单抗纷纷出海,布局更广阔的国际市场。业界用“PD-1后时代”来形容当下抗体药物研发的现状。与此同时,在国内已有6款上市PD-1单抗药物的情况下,还有近80个国产PD-1正处于研发阶段。我们该如何看待抗体药物同质化竞争的现状?缪小牛认为需要差异化竞争,这也是普米斯生物聚焦双特异性抗体和纳米抗体的原因。  缪小牛说:“PD-1后时代,是到了一个挑战很大机遇也很多的时代,因为PD-1这种靶点是很长时间才会出现一次的,这种比较低的果子已经都被摘掉了,现在我们要花更多的时间和精力,冒更大的风险去摘一些更高的果子。现在几乎所有的公司都会对肿瘤方面各种各样的靶点进行尝试,最后能够脱颖而出需要实力、速度和一些运气。  我觉得纳米抗体有自己的优势,相比较正常的抗体它比较小,组织渗透效率更高、在双抗应用中没有重轻链的错配问题。当然纳米抗体也有自己的缺点,所以我们不能说它比正常抗体好,全部换成纳米抗体,这是不对的,因为它们是互补的,它们之间的结合位点、亲和力的范围都会有一些区别,这也是普米斯为什么坚持每个项目都用纳米抗体和正常IgG同时进行筛选的原因。双特性抗体能够实现单抗没有办法替代的功能。我更希望将双特性抗体视为一个单独的药物,它就是一个分子,能够达到任何其他的单克隆抗体或者联合用药没有办法达到的功能。” 创新药研发需要企业跟研究院所、高校有紧密的联系  他说:“比如说最早做抗体的时候,大家都说你做仿制药,不要做创新药,现在,你再说我要做一个仿制药的公司是不会有人投资的。所以我觉得再往后几年,做fast follow都不一定能拿到投资,只有做全新的、有潜力的新药研发的公司才更能拿到资源,这非常有助于中国创新药公司的发展。中国现在真正的创新,在国外完全没有,中国第一个的,其实挺少的。我们可以发现在欧美,真正完全新的靶点很少或者几乎没有是从企业里出来的,大多数都是高校、研究院所的教授做了很多年的基础研究,然后企业把它转化成产品。这是一个正常的过程,因为没有一个企业会花10年或几十年的时间去研究一个靶点,然后再把它做成药。所以我觉得,现在中国的创新需要企业跟研究院所、高校有一个紧密的联系,让国内的高校、研究院所做出来的东西,在国内企业转化成first in class的药物。我觉得这种联系越紧密,对我们以后的创新越有利。“
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Encouraging the Power of Innovation|The Fifth Medical and Health Investment Bonjour List 2021 Announced

Time of issue: : 2021-03--26
 2020年疫情逆势环境之下,中国医疗健康产业投融资与并购总额却创下历史新高。医疗健康领域精英创业者与投资者,在全球生命科学与医疗领域形成的“中国力量”,产业发展正迎来激扬时代!  2021年3月26日,由专注中国医疗健康的产业投行浩悦资本主办的第五届医疗健康投资卓悦榜峰会在中国上海成功举办,本次峰会以“激扬”为主题,峰会现场不仅齐聚了近百位重磅嘉宾深度对话,同时正式公布了2021第五届医疗健康投资卓悦榜共计19项重磅奖项。  作为从第三方角度出发的医疗健康领域专业榜单,卓悦榜已连续五年评选并公布榜单,见证了中国创新崛起与全球资本重仓中国的精彩历程。榜上优秀医疗健康投资机构成为了创新企业的助推器和长期伙伴,诸多创新企业带着卓悦榜的奖项成功登陆公开资本市场。  由一批“产业人”带队的浩悦资本,是业内首个践行“产业投行”理念的医疗健康投行。自2014年成立以来,浩悦资本从未停止对医疗健康产业细分领域的专注研究,包括生物医药、创新医疗器械、IVD与精准医疗、医疗服务、智慧医疗等重点赛道,业务涵盖私募融资、兼并收购以及跨一二级市场的产业整合,合作伙伴涵盖医疗健康以及跨行业的优秀企业与投资机构。浩悦中国医疗产业精选美元基金也即将完成首轮募资,投行业务与基金的双轮驱动模式逐步成型。  本届浩悦资本医疗健康投资卓悦榜峰会现场,共设7场圆桌论坛,近百位创业者、投资人以及企业家同台对话,分享医疗产业发展与投资的精彩观点视角。峰会上,浩悦资本创始人、首席执行官刘浩先生发表峰会同名主题演讲。我们将持续通过浩悦资本及浩悦分享微信公众号发布峰会精彩亮点,以下为本届卓悦榜首发榜单。 第五届医疗健康投资卓悦榜完整榜单
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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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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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