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Recently, the Alliance for Regenerative Medicine (ARM) released a report for the first half of 2020 entitled "Innovation under the New Crown Outbreak".
According to ARM, the number of companies working in the field of regenerative medicine (including gene therapy, cell therapy, cell therapy, tissue engineering technology using genetic engineering) has exceeded 1000 for the first time, including 515 gene therapy enterprises, 632 cell therapy enterprises, 136 tissue engineering/biomass technology enterprises, some enterprises are also committed to the development of a variety of technologies.
Despite the huge economic challenges of the COVID-19 pandemic, the suspension or delay of many clinical trials and regulatory difficulties, the regenerative medicine sector remains strong in 2020 and is on track to be a record year for financing.
the first half of 2020, the sector raised $10.7 billion, up from $9.8 billion for the whole of 2019, an increase of 120 percent over the same period, with a good chance of breaking the record for the highest funding for cell and gene therapy in 2018 ($13.5 billion).
the total amount raised for gene and gene modified cell therapy was $7.9 billion, the total amount raised for cell therapy was $7.5 billion, and the total amount raised for tissue engineering was $840,000.
total, early venture capital, late IPO and other stages of financing have a better performance, 33 financing more than 100 million U.S. dollars.
Iovance Biotherapeutics, Bluebird Bio, Allogene and Sana Biotechnology have more than $500 million in financing.
the first half of 2020, five gene and cell therapy companies successfully IPO: Nanjing Legends: founded in 2014, dedicated to cancer-related CAR-T therapy development.
, Nanjing Legend was listed on NASDAQ as "China's first CAR-T-listed stock" with a market capitalisation of $4.3 billion.
, its heavyweight LCAR-B38M, is expected to file for listing in the U.S. by the end of this year and in China in 2021, according to a previously issued prospecto.
Passage Bio: Founded in 2019, it is dedicated to gene therapy for rare single-gene central nervous system disease (CNS) and is currently in clinical phase this year, including GM1 neurosaltide lipid disease and frontal lobe dementia (FTD).
Akouos: Founded in 2016, it is dedicated to drug development based on the AAV gene platform for diseases such as hearing loss.
Bio: Founded in 2016, we are committed to the development of gene therapy for rare diseases, including eight projects for rare and endemic diseases of the liver and retina.
: Founded in 2018, Zhang Feng, David Liu and J. Keith Joung co-founded the world's first innovative company to develop precision gene drugs using single-base editing technology.
1078 clinical trials are currently under way worldwide, including 394 Phase I clinical trials, 587 Phase II clinical trials and 97 Phase III clinical trials.
359 gene therapies, 471 cell-based cancer immunotherapy (including CAR-T, TCR cell therapy, tumor immersion T-cell therapy, etc.), 204 cell therapies, and 44 tissue engineering therapies.
same time, in response to the continued global spread of COVID-19, several academic research centers and therapeutic development organizations announced that they are studying the use of regenerative medicine technology to treat the disease in the short term and to address related complications in the future.
, 11 clinical trials based on the treatment of COVID-19 are under way worldwide, and another 25 research and development projects are in the preclinical development phase.
, 665 clinical trials focused on oncology, accounting for 62% of the total number of clinical trials.
other more clinical trials include musculoskeletal diseases (58), endocrine, metabolic and genetic diseases (55), central nervous system diseases (52), and cardiovascular diseases (45).
the first half of this year, several late-stage cell and gene therapies reached important milestones: Novartis' Zolgensma gene therapy was approved by EMA and Japan's Ministry of Health and Labour; Children with anti-host disease (SR-aGVHD); Fosun Kate CAR-T product Equilien injection application (CXSS20000006) was accepted by the FDA; and the first three submitted a new drug listing application (NDA) for CAR-T cell therapy Axi-Cel, Yescarta. Pharma's CAR-T therapy KTE-X19 and BMS's CAR-T therapy liso-cel are both eligible for FDA-granted priority review and are expected to be approved for listing this summer (KTEX-X19 was approved by the FDA on July 24).
there is no denying that the new crown outbreak has made it difficult to conduct clinical trials and regulatory approval, but even so, ARM expects several regenerative medicine therapies to be submitted for regulatory applications and approval in the second half of this year.
In the Time of COVID-19