HELP Therapeutics (China)

HELP Therapeutics (China), operating under the Chinese name 艾尔普再生医学 (Nanjing HELP Therapeutics Co., Ltd.), is a regenerative-medicine company founded in 2016 and headquartered in Nanjing, Jiangsu, China. The company positions itself around the vision "Live Better & Longer" and the stated goal of helping people live healthily to the age of 120. Its core focus is the development of "off-the-shelf" (universal, ready-to-use) cell medicines derived from induced pluripotent stem cells (iPSCs), aimed at degenerative and age-related intractable diseases. The company has built its pipeline across three main therapeutic areas: cardiovascular disease, bone-metabolism disease, and ophthalmic disease. Its lead cardiovascular programs include HiCM-188 for advanced heart failure (being pursued in both China and the United States) and HiCM-388 for acute myocardial infarction in China. In bone metabolism it is developing HMM-910 for postmenopausal osteoporosis in China, and in ophthalmology HiO-630 for dry age-related macular degeneration in China. These programs span stages from proof-of-concept and preclinical work through investigator-initiated trials (IIT) and Phase I to Phase III/NDA. HELP Therapeutics relies on a self-built automated cell-manufacturing platform, described as a fully automated, high-scale, industrial-grade cell-manufacturing robotic platform. This platform underpins its ambition to make cell therapies that are safe, reliable, cost-controllable, and affordable for patients. The company has also been designated the responsible unit for the "China Intractable Disease iPS Cell Model Bank," which sits under the National Human Genetic Resources Sharing Service Platform, and it holds a national administrative license for the preservation of human genetic resources. HELP Therapeutics is a private company. It completed a Series C financing round in the hundreds of millions of RMB in 2021. It maintains offices in Nanjing (headquarters), Shenzhen, Hong Kong, Beijing, and Shanghai, and has established joint laboratories, including with the University of Macau and the Oujiang Laboratory. Its work has been recognized through national key R&D programs, inclusion in the National 13th Five-Year Plan Science and Technology Innovation Achievement Exhibition, and coverage in journals such as Nature Medicine.

HELP Therapeutics (China), known in Chinese as 艾尔普再生医学, was founded in 2016 and is headquartered in Nanjing, Jiangsu, China. From its inception the company focused on regenerative medicine, specifically cell therapies derived from induced pluripotent stem cells (iPSCs), targeting intractable diseases associated with aging. In 2017 the company took on the role of responsible unit for the construction and operation of the "China Intractable Disease iPS Cell Model Bank," which is affiliated with the National Human Genetic Resources Sharing Service Platform. That same year it also participated in a national key R&D program on stem cell therapy for heart failure. In 2018 HELP Therapeutics advanced preclinical research on its heart failure pipeline. In 2019 it launched clinical research on iPSC-based therapy for moderate-to-severe heart failure. In 2020, Nature reported a one-year follow-up of iPSC-derived cardiomyocyte treatment for moderate-to-severe heart failure, and the company's iPSC-based cell products passed testing by the National Institutes for Food and Drug Control (NIFDC), helping to establish industry quality standards. The year 2021 was a period of significant progress. The company's human iPSC-derived regenerative cardiomyocyte project passed National Health Commission clinical research filing (MR-32-21-014649). It received a national administrative license for the preservation of human genetic resources (Guokeyiban Shenzi [2021] BC0022). It was selected for the National 13th Five-Year Plan Science and Technology Innovation Achievement Exhibition. It also completed a Series C financing round in the hundreds of millions of RMB. Additionally, it secured a special project under the National Health Commission's "National Science and Technology Resource Sharing Service Platform Plan" for the standardized construction and application of a human iPSC-derived cell model bank (YCZYPT[2020]06-3). In 2022 the company was awarded a National Key R&D Program "Stem Cell Research and Organ Repair" special project (2022YFA1105100) on tissue-engineered blood vessel construction using stem cells and biomaterials for ischemic heart disease. It also obtained Jiangsu provincial and Nanjing municipal life-health special project support, and established joint laboratories with the University of Macau and the Oujiang Laboratory. In 2023 the company's heart failure drug based on iPSC technology, "human iPSC-derived cardiomyocyte injection," received IND approval (acceptance number: CXSL2200547). In 2024 it achieved two further regulatory milestones: an IND license in China for its osteoporosis treatment product "human umbilical cord mesenchymal stem cell injection," and a U.S. FDA IND license for its heart failure cell therapy product "human iPSC-derived cardiomyocyte injection." Across its development, HELP Therapeutics has built an automated cell manufacturing platform described as a fully automated, high-scale, industrial-grade cell-manufacturing robotic platform. Its pipeline now spans cardiovascular, bone-metabolism, and ophthalmic disease areas, with programs at various stages from proof-of-concept to Phase III/NDA. The company maintains offices in Nanjing, Shenzhen, Hong Kong, Beijing, and Shanghai, and has been recognized as a National High-Tech Enterprise and a standing council member of the China Stem Cell Industry Alliance, among other honors.

• 2024

  China IND license for 'human umbilical cord mesenchymal stem cell injection' for osteoporosis; U.S. FDA IND license for 'human iPSC-derived cardiomyocyte injection' for heart failure.

• 2023

  IND application approved for 'human iPSC-derived cardiomyocyte injection' for heart failure (acceptance number: CXSL2200547).

• 2022

  Awarded National Key R&D Program 'Stem Cell Research and Organ Repair' special project (2022YFA1105100); established joint laboratories with University of Macau and Oujiang Laboratory.

• 2021

  Human iPSC-derived regenerative cardiomyocyte project passed NHC clinical research filing (MR-32-21-014649); received national human genetic resources preservation license (BC0022); selected for National 13th Five-Year Plan Science and Technology Innovation Achievement Exhibition; completed Series C financing in hundreds of millions of RMB.

• 2020

  Nature reported one-year follow-up of iPSC-derived cardiomyocyte treatment for moderate-to-severe heart failure; iPSC-based cell products passed NIFDC testing.

• 2019

  Launched clinical research on iPSC-based therapy for moderate-to-severe heart failure.

• 2018

  Advanced preclinical research on heart failure pipeline.

• 2017

  Became responsible unit for the China Intractable Disease iPS Cell Model Bank under the National Human Genetic Resources Sharing Service Platform; participated in national key R&D program on stem cell therapy for heart failure.

• 2016

  HELP Therapeutics (艾尔普再生医学) founded.

Developer of affordable, off-the-shelf iPSC-derived cell therapies for age-related intractable diseases.

• HiCM-188

  iPSC-derived cardiomyocyte injection for advanced heart failure, in development in China and the United States.

• HiCM-388

  iPSC-derived cardiomyocyte injection for acute myocardial infarction, in development in China.

• HMM-910

  Human umbilical cord mesenchymal stem cell injection for postmenopausal osteoporosis, in development in China.

• HiO-630

  iPSC-derived product for dry age-related macular degeneration, in development in China.

1. 1HELP Therapeutics - 艾尔普再生医学 (official homepage)helptherapeutics.com
2. 2关于我们 - HELP Therapeutics - 艾尔普再生医学helptherapeutics.com
3. 3HELP Therapeutics (China) - Wikidatawikidata.org