首页置顶 – 恒赛生物

恒赛生物树突细胞疫苗药物产研项目开工仪式圆满举行

admin — Wed, 14 Aug 2024 05:36:00 +0000

Shanghai, August 14, 2024 -- On today's sunny day, Shanghai Hengsai Bio-technology Co. The groundbreaking ceremony. The commencement of the project marks another important milestone for Hengsai Biotechnology in the field of biopharmaceuticals, and also signifies its continuous deep plowing and breakthrough in the field of cell therapy.

At 9:08 a.m., the groundbreaking ceremony was officially opened at Life Blue Bay, a new area in Lingang. (hereinafter referred to as "Lingang Fengxian"), Lv Jun, Vice Secretary of the Party Committee and General Manager, Wu Fumin, Vice Chairman and Deputy Secretary of Shanghai ITC, Cheng Xiangguo, Co-founder and Deputy General Manager of Hengsai Bio, Zhu Jincai, General Manager of Shanghai 3D Engineering, Yan Kun, Chairman of Zhenyue Fund, Liu Huawei, General Manager of Zhenchuanghui Incubator, Ji Zhaozhao. Yan Kun, Chairman of Zhenyue Fund Liu Huawei, General Manager of Zhenchuanghui Incubator Ji Zhaojia.

Lv Jun, Deputy Secretary of the Party Committee and General Manager of Lingang Fengxian CompanyHe delivered a warm speech, firstly, he expressed his warm congratulations on the smooth commencement of the project and expressed his heartfelt thanks to friends from all walks of life who have long supported and cared about the construction of the park. Mr. Lv pointed out that in recent years, with the rapid development of medical science and technology, the tumor treatment is gradually changing from traditional radiotherapy to the precision treatment with immune targeting as the core. As an important member of the body's immune system, the research and development of vaccine drugs for dendritic cells (DC) is regarded as an emerging pathway for anti-tumor treatment, with a broad application prospect. Since signing the contract to move into the park in early 2021, Hengsai Biological has not only successfully completed the pilot R&D project of Phase I DC vaccine, but also ushered in the commencement of the Phase II large-scale production project, which is undoubtedly another major breakthrough made by the company in the field of immunotherapy. Mr. Lv emphasized that the growth of Hengsai Biologicals in the park could not be separated from the hard work of every employee of Hengsai team and the support and help of our partners. In the future, Lingang Fengxian will continue to strengthen its service empowerment and work hand in hand with Hengsai Biologicals to jointly promote the subversive innovation of targeted drugs and bring more effective and safer treatment solutions for tumor patients.

Dr. Liu Huining, Founder and CEO of Hengsai BiologicalsHengsai Bio focuses on the R&D and industrialization of DC vaccine, and has successfully completed the tasks of Phase I project through unremitting efforts. Today, the successful commencement of Phase II production and research project is not only an important point in the development course of Hengsai Biologicals, but also a key step towards the world's leading DC vaccine research and development enterprise. Hengsai Bio is confident that on the fertile land of Life Blue Bay in Lingang New Area, Hengsai Bio will rely on its institutional advantages and innovative environment to accelerate the project process and bring safer and more efficient immunotherapy products to patients around the world."

Cheng Xiangguo, Co-founder and Deputy General Manager of Hengsai BiologicalsAt the groundbreaking ceremony, he delivered a speech: "Lingang Blue Bay, as the pioneer bearing area for biomedical industry in the new Lingang area, brings together all kinds of resource advantages and policy advantages, and provides the company with a broad space for development. We would like to thank the leaders at all levels of Lingang Fengxian Company for their support and assistance. We believe that under the care of leaders at all levels and the joint efforts of the project team, the Phase II production and research project will be completed on schedule and operated efficiently!"

Hengsai Bio's R&D center and pilot plant in Shanghai Lingang Blue Bay were put into use in 2021, and Zhongshan R&D center is under construction. The company's first pipeline KSD-101 has successfully completed the dual reporting in China and the United States, and is about to formally enter the registered clinical stage. The Company has now established stable partnerships with a number of domestic and international research institutions and tertiary hospitals to carry out clinical research and technical cooperation in order to comprehensively verify the clinical safety and efficacy of the DC vaccine. Period completion and efficient operation!"

中国首款！恒赛生物原创DC疫苗KSD-101获得FDA IND批件

admin — Sun, 31 Mar 2024 01:44:00 +0000

2024年3月30日，恒赛生物宣布首发管线KSD-101获得美国食品药品监督管理局（FDA）授予新药临床试验（IND）许可，成为我国首款获得美国FDA IND批件的原创树突细胞疫苗(DC疫苗)产品。

恒赛生物创始人兼CEO刘慧宁博士表示：“很高兴与大家分享这一喜讯， KSD-101的安全性和有效性在临床IIT研究中已得到初步验证，现在即将正式进入注册临床阶段，这是公司研发进展的重要里程碑。本次获批临床是境外药物监管机构对我们DC疫苗的全方位高度认可，彰显了公司在免疫治疗领域的创新能力和国际竞争力。目前我们正在积极推动KSD-101在国内的注册申报并筹备生产基地的建设。”

关于KSD-101

KSD-101是负载EB病毒相关类肿瘤复合抗原的人单核细胞来源自体树突细胞疫苗。通过细胞因子诱导单核细胞转化为树突细胞，用类肿瘤复合抗原负载树突细胞并诱导其成为成熟的树突细胞，制备成树突细胞疫苗，是一种肿瘤治疗性疫苗。通过皮下注射后能在人体内激活EBV特异CTL，从而实现对肿瘤细胞的有效识别及杀伤，具有良好的有效性及安全性。
关于恒赛生物

Founded in 2018, Hengsai Bio is a scientific and technological innovative enterprise and national high-tech enterprise dedicated to the research, development and industrialization of dendritic cell vaccines (DC vaccines). The company has successfully constructed the Eco-DCVax platform, aiming to break down the technical barriers to industrialization and develop global First-in-Class high-quality DC vaccine products with independent property rights that are safe, efficient and convenient to administer. The developed product, therapeutic dendritic cell vaccine, provides a new approach and strategy for the treatment of relapsed and refractory tumors, chronic viral infections, autoimmune diseases and other diseases that are in urgent need of effective clinical treatments.
Hengsai Bio's R&D center and pilot plant in Shanghai Lingang Blue Bay officially came into operation in 2021, and a large-scale R&D/production base is under construction. The company has now established stable cooperative relationships with a number of domestic and foreign research institutions and tertiary hospitals, and is in the process of dual-reporting between China and the U.S. to carry out clinical research and technical cooperation in order to comprehensively verify the clinical safety and effectiveness of the DC vaccine.

2023 ASH |恒赛生物走向国际学术舞台，展示血液肿瘤最新研究成果

admin — Fri, 15 Dec 2023 02:53:00 +0000

ASH 2023

Hensel Biologics USA - San Diego

65thAmerican Society of Hematology (ASH) Annual MeetingHeld on December 9-12, 2023 in San Diego, USA, as the largest, most numerous and most influential annual meeting in the field of international hematology, this ASH Congress gathered 35,000 experts and scholars from 109 countries and regions around the world to present their latest results, exchange the latest experience in research, and discuss the latest trends in the development of hematology.

Experts and scholars attending this international academic event, in the intense four-day period, in the form of conference exchanges and venue boards, achieved the purpose of exchanging academics, communicating information, enhancing understanding, passing on friendship and strengthening cooperation, and pointed out the direction for future research and development of hematology.

Hengsai Biotechnologya biotechnology company dedicated to immunotherapy.Founder Dr. Huining LiuAfter returning to China, he led an excellent team to continue his basic immunology research at Harvard Medical School and translate the results. Initial Research ResultsKSD-101 in patients with EBV-associated hematologic neoplasms: results of an ongoing phase I clinical study.Selected for this event and attracting attention .

The study showed thatAutologous Dendritic Cell (DCC) Vaccine, which has a favorable safety profile for the treatment of EB (Epstein-Barr) virus-associated hematologic neoplasms, is effective in inducing an immune response and has achieved encouraging clinical efficacy.

EBV (Epstein-Barr virus) is a common virus that is closely associated with the development and progression of many hematologic tumors. The treatment of EBV-associated hematologic tumors is still a clinical challenge.

KSD-101 is a new product developed by Hengsai Biotechnology.Novel cellular drugs targeting EBV-associated hematologic tumors, by inducing the specific immune function of dendritic cells against tumors and enhancing the body's ability to attack tumor cells, thus achieving the purpose of inhibiting tumor growth and proliferation.

Being able to present its research results on the highest international academic stage of hematology and being recognized by its peers fully reflects the scientific strength and influence of Hengsai Biologicals in the field of hematology research, and it is hoped that such cutting-edge research can make positive exploration and breakthroughs in the treatment of hematological diseases.

In this feast of academic exchanges, Hengsai Bio-team participated in several seminars and presentations related to our research direction. The experts were full of interest in our research, and discussed and exchanged with us in depth, sharing different views and experiences. This atmosphere of academic exchanges not only broadened our horizons, but also met many colleagues . It is this atmosphere that stimulates innovative thinking and promotes the rapid development of hematology research.

At the same time, the interview of Prof. Chunrui Li of the Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, the PI of the clinical research of KSD-101 by Medical Pulse also let more people know the latest research results of Hengsai Biologicals, and increased the company's popularity. This interview is not only a recognition of Hengsai Bio, but also an affirmation of the results of our team's efforts.

We have benefited greatly from this international academic exchange that transcends borders, races and beliefs. The research results from different experiences and backgrounds have given us deep insights and new directions for solving some of the difficult problems that have been bothering us for a long time. More importantly, such on-site exchanges have inspired our confidence and motivation to continue our research efforts.

Under the leadership of Dr. Liu Huining, Hengsai Biotechnology, with the spirit of science and pioneering, is united in its efforts to become a first-class biotechnology company in the industry and work hard for the development of human science.

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恒赛生物完成亿元级A轮融资

admin — Mon, 27 Nov 2023 06:09:00 +0000

Recently, following the completion of tens of millions of financing last year, Hengsai Biological has successfully completed the 100 million yuan A round of financing again this year. This financing is provided byFuhui Venture CapitalLeading the investment.Chintz Capital,Knight Rider Kang YingFollow-through.M劢 Capitalacted as the exclusive financial advisor.

Hengsai Bio's R&D center and pilot plant in Shanghai Lingang Blue Bay officially came into operation in 2021, and a large-scale R&D/production base is under construction. The company has now established stable cooperative relationships with a number of domestic and foreign research institutions and tertiary hospitals, and is in the process of dual-reporting between China and the U.S. to carry out clinical research and technical cooperation in order to comprehensively verify the clinical safety and effectiveness of the DC vaccine.

At present, there is no approved DC vaccine product in China. Hengsai Biological has now built a complete DC vaccine comprehensive R&D platform and technology system, including DC cell separation and induction technology at the international leading level, tumor antigen selection and loading platform, clinical trial level DC cell production center, quality control and management system, and so on. On the basis of cutting-edge overseas DC vaccine R&D experience, the company has further improved and established a standardized and regulated DC vaccine production method, which is convenient for industrialization. The overall technical level is in the international leading position, and we own a number of invention patents, which fill the gaps in this field in China.

Dr. Liu Huining, Founder and CEO of Hengsai Biologicals Inc.Hengsai Bio has a mature DC vaccine preparation process and a scientific and compliant quality control system. We are very grateful to our investors, Fortune Venture Capital, Qinzhi Capital and Kemper Capital, for their recognition and trust in our company, as well as the support of MaiPai Capital. This round of financing will help us advance our product pipeline and clinical filings. The Hengsai team will continue to develop safer, long-lasting, and more affordable DC vaccines by focusing on clinical needs and driven by technological innovation.

Fortune Ventures Investment TeamIt means: With the deep strategic cooperation with Shanghai Institute of Pharmaceutical Sciences of Chinese Academy of Sciences and Zhongshan Municipal Government, Fortune Venture Capital has been committed to promoting the development of more high-quality innovative drug companies in Cuiheng New District of Zhongshan City for a long period of time. Hengsai Bio, as a leading DC cell therapy company in China, is a representative of the high-quality enterprises we have cooperated with for a long time, and we will continue to help Hengsai Bio to develop rapidly and grow into a leading DC cell therapy company in the world.

Qinzhi Capital Investment Teamsaid: Hengsai Biological's new generation DC vaccine technology has many advantages, which makes it have a wide range of application prospects. The company's core founding team has many years of experience in cell therapy, has established a relatively mature DC vaccine preparation process, and has a scientifically compliant quality control system, all of which will contribute to the company's long-term sound development. We expect Hengsai Bio's DC vaccine to bring positive impact and substantial help to patients as soon as possible.

Bo Chen, Managing Partner of Knight Rider Kang YingHengsai Bio-developed the international leading DC vaccine culture technology, which makes the antigen versatility and effectiveness get the best expression, and creates a new way of tumor vaccine with remarkable efficacy and easy to be industrialized, and we are looking forward to seeing that Hengsai can continue to conquer many kinds of viruses caused by the tumor disease, and benefit the patients with this kind of "terminal disease".

Huanxing Ding, Partner at M劢 CapitalMr. Sheng said: DC vaccine has the advantages of low cost, good efficacy, low side effects and convenient clinical use, etc. Hengsai Bio has made great progress in R&D rapidly following the last round of financing, and we believe that Hengsai Bio will lead the development of DC vaccine industry after this round of financing.

Fuhui Venture Capital

Fortune Ventures is a VC investment organization focusing on the transformation of scientific and technological achievements and early-stage investment in science and technology enterprises, and has invested in a number of high-quality companies in the medical and healthcare field, including Nuohui Health (06606.HK), Eagle Pupil Technology (02251.HK), Cascade, Ziben Pharmaceuticals, Huazi Biologicals, Bajie Hongye, Uri Pharmaceuticals, Luoqi Biologicals, Ruishun Biologicals, and so on.

Chintz Capital

Shenzhen Qianhai Qinzhi International Capital Management Co., Ltd. brings together senior industry professionals from SZV, Roche, GSK, BMS, Abbvie, AstraZeneca, UW Life, etc., with offices in Shenzhen, Shanghai, Hangzhou, Changzhou, Dongguan, Zhongshan, etc., and has initiated and set up nearly forty RMB and US dollar funds. In January 2023, the company was honored as one of the "Top 30 Growth-oriented VC Investment Institutions in China in 2022" in the annual list of China's venture capital industry.

Knight Rider Kang Ying

Cavalcade is an industrial investment firm specializing in investing in cutting-edge biopharmaceutical companies. It consists of experienced healthcare investors who have invested in a number of early-stage companies with extremely high growth potential.

M劢 Capital

MedBio Capital is a boutique investment bank specializing in the life sciences and healthcare sectors, dedicated to being a capital and strategic partner to top scientists and entrepreneurs. MedBio Capital's core team has been deeply involved in the healthcare industry for many years, covering key nodes of R&D, clinical and marketing, and has a strong background in investment, investment banking and consulting. The team members have completed a total of over 10 billion dollars in financing, and have served more than ten top medical listed companies.

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