Events
On the evening of February 28, 2022 Eastern time and the afternoon of February 28, 2022 us time, authoritative websites such as the Wall Street Journal and endpoint released that the FDA approved the cell therapy of Johnson & Johnson / Legend (Kingsley American cell therapy subsidiary), with the trade name of carvykti, for the treatment of refractory / recurrent multiple myeloma (RRMM) in adult patients.
Commentary
Milestones in the rapid breakthrough of China’s cell therapy industry: (1) this car-t for the treatment of refractory or recurrent multiple myeloma (RRMM) is the second car therapy targeting BCMA in the world; It is also the first product of Chinese cell therapy approved for listing overseas. (2) This car-t has excellent similar data. According to the company’s speech at the latest JPM conference, after a median of 24 months of long-term follow-up, the primary endpoint overall response rate (ORR) was 97.9%, very good partial response (vgpr) was 94.9%, and 82.5% of patients achieved strict complete response (SCR). 60.5% of the patients survived without disease progression after 2 years. Of the 61 patients who could be evaluated by MRD, 92% were 10-5mrd negative. (2) At present, this car-t has six clinical advances. In particular, the clinical progress (applicable to the patient market or multiple expansion) from the end-line patients to the front line of treatment (for example, 2 / 3 line patients) deserves close attention.
Another milestone of China’s innovative medicine going to sea. (1) The approved car-t therapy was developed by legendary Biology (legn. O), an American cell therapy subsidiary of Kingsley Biotechnology (1548. HK), a Hong Kong stock company based in Nanjing, and cooperated with Johnson & Johnson’s subsidiary Janssen to jointly commercialize products in the United States. This is the first time that the global heavy innovative drug / therapy originally developed by China has been approved by FDA in the United States, marking that the R & D level of innovative drugs in China has entered a new height and development stage. (2) Previously, zebutinib, a Btk inhibitor for the treatment of mantle cell lymphoma in Baiji, was approved in the United States in November 2019 (approved in China in June 2020). Since then, dozens of innovative drugs originally developed in China have submitted marketing applications and are under the review of drug regulatory agencies in the United States and Europe. The prelude to the internationalization of China’s innovative drugs has been opened.
Only through innovation can there be a future. Both China and overseas markets are worth looking forward to. (1) Over the past six months, the pharmaceutical sector has performed poorly under the triple concerns of medical insurance negotiation, supply chain concerns and the market’s internationalization of Chinese innovative drugs and the successful commercialization of Chinese innovative drugs. We believe that there is a poor expectation between these triple concerns and the fundamentals of industry enterprises. (2) In terms of innovative drugs going to sea, Xinda biology, as the leader of innovative drugs in China, recently made a very meaningful milestone exploration on the conditions required for China’s innovative drugs to enter the international innovation core market at the ODAC meeting held after the US Food and Drug Administration accepted its listing application of PD-1 monoclonal antibody for non-small cell lung cancer. This time, the legendary biological car-t therapy, a subsidiary of Kingsley biotechnology, was approved in the United States with excellent clinical data, which further verified the strength of China’s R & D. In April, the confirmation of approval of Shanghai Junshi Biosciences Co.Ltd(688180) PD-1 at the US Food and Drug Administration will be welcomed. (3) In terms of commercialization and cash in the Chinese market, there are many poor expectations in the market; For example, for the high-priced anti-tumor drugs for the indications of end-line patients, the market is worried about the restrictions on the commercialization process of patients who are not included in the medical insurance varieties. According to the public data, such innovative drugs as cell therapy, the participation of Huimin insurance and commercial insurance, and the payment power of patients are better than market expectations. (4) We believe that innovation is necessary, and it is certain that the life cycle of innovative drugs will be shortened. Therefore, China’s top pharmaceutical enterprises need to have a rich level of global innovation and international cooperation.
Investment advice
We continue to be optimistic about Kingsley biotechnology, China’s innovative drug sector and cell therapy sector; Focus on the targets of cell therapy in Hong Kong Stock Market: Kingsley biotechnology, Yaoming junuo and Keji pharmaceutical; Related subjects of A-share cell therapy: Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (associate subsidiary Fosun Kate with 50% equity), Zhejiang Jolly Pharmaceutical Co.Ltd(300181) (participation in Keji pharmaceutical).
Risk tips
Innovative enterprises may face the risk of huge performance fluctuations such as R & D failure, patent and medical legal disputes.
The market cannot objectively interpret the clinical trial data results of innovative enterprises, resulting in the risk of severe market fluctuations
