The car-T products of the local biopharmaceutical company Legendary Bio have experienced the double days of ice and fire.
On February 16, Jinsray Bio (01548. HK) announced that the Phase 1 clinical trial of its CAR-T product LB1901 of Legendary Biologics (NASDAQ: LEGN) has been suspended by the FDA, however, less than two weeks later, on March 1, Legendary Announced that another CAR-T product it has developed independently, Sidakiolus (English trade name: CARVYKTI, or Cilta-cel), has been approved by the US FDA for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM).
It is reported that this is China's first FDA-approved innovative biological products, but also the world's second TARGET BCMA CAR-T therapy, the industry has said that the approval of China's innovative drugs "going to sea" has a milestone significance.
Indigenous biological innovative drugs successfully "go to sea"
Founded in 2014, Legendary Bio is incubated from within Kingsway Biotechnology Company, which is a biopharmaceutical company integrating R&D, clinical, production and commercial development of tumor immune cell therapy, and bears the aura of "Top 100 Pharmaceutical Innovation Enterprises in China" and many other halos.
In June 2020, LegendAry Bio, as the first stock of Car-T in China, successfully landed on the NASDAQ, and its new drug Sidakiolalensay, a class 1 new drug for therapeutic biologics, was recognized as China's first breakthrough therapy in August 2020, and officially submitted a listing application to the US Food and Drug Administration (FDA) in December 2020.
As an innovative and potentially cancer-curing new tumor immunotherapy method, CAR-T cell immunotherapy has attracted much attention from the industry in recent years. The therapy is mainly used to treat blood cancers, where the patient's T cells are extracted and modified as CAR-T cells and then transfused back into the patient to accurately attack the cancer cells.
In addition to the core product Sidaki olense, which was successfully launched in the United States, the company also has a number of CAR-T therapies under research for the treatment of blood tumors, solid tumors and other difficult diseases, and many studies rank at the leading level in the field of global immune cell therapy.
For the approval of Sidaki Olense in the United States, Dr. Huang Ying, CEO and Chief Financial Officer of Legendary Bio, said that multiple myeloma has not been cured so far, and patients who have received too many treatments in the past still face poor prognosis and limited treatment options. "The approval of CARVYKTI is significant for Legendary Bio, the first product approved to market since our inception and the first to bring numerous cell therapies to patients."
Cell therapy products are favored by pharmaceutical giants
On the stage of CAR-T cell immunotherapy, Sidaki Ollensy can be said to surprise all parties as soon as it appears.
At the American Society of Clinical Oncology (ASCO) in 2017, Legend Bio reported the results of a clinical trial in which Sidakiolasil treated patients with relapsed or drug-resistant multiple myeloma — the overall response rate of 35 patients treated with relapsed or drug-resistant multiple myeloma reached 100%, which immediately attracted widespread attention from the international medical community.
After the ASCO meeting, 8 world-renowned pharmaceutical companies threw hydrangea balls to legendary organisms. In the end, Legendary Bio chose Janssen (Johnson & Johnson) and reached a global exclusive licensing and cooperation agreement to jointly develop, produce and sell for the global market under a 50/50 (70/30 in Greater China) fee/profit distribution agreement. At the same time, Janssen (Johnson & Johnson) paid a down payment of US$350 million and a milestone payment of higher amount to Legendary Biotech, which set a record for the largest down payment of foreign patent authorization of Chinese pharmaceutical companies and the best conditions for cooperation.
As a personalized therapy, the use of Cedar Chiolanza requires extensive training, preparation and certification to ensure a good experience for patients with the best possible treatment outcome. Legendary Bio and Janssen agreed to launch a network of certified treatment centers in phases from 2022 onwards, expanding production capacity and increasing Sidaki Olensey's availability throughout the United States, ensuring that CARVYKTI is available to oncologists and their patients in a reliable and timely manner.
With the successful listing of Sidaki Ollensy, it is believed that patients with multiple myeloma in the United States will soon be able to use the CAR-T products developed by Chinese biotechnology companies.
The revelation of the "breakthrough of zero"
In the context of the obstruction of fda approval of a number of innovative drugs in China, the successful "going to sea" of the legendary biological Sidakiolensai is indeed exciting.
So far, including the legendary biological Sidaki Olonsay, the US FDA has approved the marketing of 6 CAR-T cell therapies. There are also two imported CAR-T therapies on the market in China: one is Fosun Kate's Agilense Injection priced at 1.2 million yuan/ bottle, and the other is the first domestic CAR-T product to win the First Class 1 new drug, WuXi Juno's Reggironse Injection. At present, there are many companies or institutions that lay out CAR-T cell therapy in China, among which the number of products is at the top of the legendary biology, Sibiman biology, Keji Pharmaceutical, Genxi biology and so on.
Legendary Biology with Sidakiolensee approved in the United States to achieve a "zero breakthrough" in the overseas listing of domestic cell therapy drugs, but some industry analysts pointed out that the innovation of pharmaceutical companies itself contains greater risks, on the one hand, the initial investment is very huge; on the other hand, there is uncertainty in the development and approval of varieties; there is an intensification of competition, in the current CAR-T track, a large number of pharmaceutical companies in the layout, the future competition will be very fierce.
Wu Wushu, vice president of the legendary biological product development platform, said in an interview with the media that the APPROVAL OF the US FDA for Siddha Chiolensay is based on the results of a clinical study conducted in the United States in the 1b/2, open label, and multi-center clinical research. "Together with our partner Johnson & Johnson, we have always maintained good and adequate communication with the FDA, which is indispensable for smoothly advancing clinical trials and new drug review and listing."
The above analysts pointed out that the successful "going to sea" of the legendary biological CAR-T cell therapy is conducive to enhancing the confidence of domestic biomedical enterprises in overseas markets, and will also provide useful experience for the "going out" of domestic innovative drugs, with more CAR-T products listed at home and abroad, it will further increase market penetration, which has certain significance for expanding the scale of the CAR-T market.
[Reporter] Ou Xujiang
【Author】 Ou Xujiang
Healthy living circle