消息面上，科济药业11月6日在公司官微上公布了其产品赛恺泽（泽沃基奥仑赛注射液）、CT071和CT0590的数据，并宣布这三项数据将在第66届美国血液学会（ASH）年会上以壁报形式展示，该会议将于12月7日至10日举行。① The trial data of SciClone Pharmaceutical's universal CAR-T product CT0590 has attracted the attention of many investors, leading to a consecutive sharp increase in stock price over two trading days; ② If the universal CAR-T product is approved for listing, CAR-T drugs may no longer be 'sky-high'; ③ SciClone Pharmaceutical told Caishou Society reporters that the company will actively promote product overseas.
Caishou Society news on November 8 (Reporter Lu A Feng): Investors' enthusiasm for innovative drugs has driven the recent market frenzy in the secondary market innovative drug sector. SciClone Pharmaceutical-B (02171.HK), which will showcase its universal CAR-T product CT0590 trial data at the upcoming American Society of Hematology (ASH) annual meeting, seems to be a 'hot cake' in the eyes of investors.
Today, CAR-T concept stock SciClone Pharmaceutical-B saw the highest intraday increase of 36.13%; yesterday, the stock price increase was 41.86%. In other words, in just two days, SciClone Pharmaceutical's market cap has nearly doubled.
On the news front, on November 6, SciClone Pharmaceutical announced on its official WeChat account the data for its products Saikai Ze (Zewo Kiolun Sai Injection), CT071, and CT0590. It was also announced that these three sets of data will be presented in poster form at the 66th American Society of Hematology (ASH) annual meeting, which will take place from December 7th to 10th.
Evidently, SciClone Pharmaceutical's trial data for the universal CAR-T product CT0590 has given investors confidence. In the first human Phase I trial of CT0590, a total of 5 subjects were enrolled with a median follow-up time of 16.6 months (range 5.1 to 24.2 months). Among them, 3 patients achieved remission, including 2 strict complete remissions and 1 partial remission. One recurrent refractory multiple myeloma (RRMM) patient's remission lasted 23 months, while another primary plasma cell leukemia (pPCL) patient's remission lasted 20 months. Preliminary data indicate that CT0590 therapy is well-tolerated and has achieved deep and lasting remission in some patients.
This means that CT0590 shows initial evidence of long-lasting efficacy, which may be the first time in the public literature that universal CAR-T therapy for treating hematological malignancies shows comparable durability in efficacy to autologous CAR-T.
Caishou Society reporters learned that the so-called 'universal CAR-T product' has characteristics such as a wide range of applicability, fast preparation speed, high success rate, and low toxicity and side effects. Currently, CAR-T products approved for listing worldwide are all autologous CAR-T products, extracted from the patient's body, modified and expanded, and then reinfused into the patient, personalized customized products.
Universal CAR-T, on the other hand, uses T cells prepared from healthy donors, requiring only a single batch preparation to supply multiple patients, even meeting the needs of hundreds of individuals, indicating that high-priced drugs like CAR-T may potentially become more 'affordable' in the future.
From the perspective of Keji Pharmaceutical, they also told Caixin reporters, "Compared with autologous CAR-T, the cost of universal CAR-T will be greatly reduced, and due to its 'spot supply' feature, the waiting time for patients will be shortened, greatly increasing the accessibility of CAR-T, breaking through the industry bottleneck of existing cell therapies, with tremendous market potential."
"This week, we also unveiled the THANK-uCAR Plus platform, which has significantly better anti-tumor efficacy in the presence of NK cells compared to THANK-uCAR. Under this platform, CAR-T targeting the same homologous BCMA or CD19/CD20 dual targets, both show strong anti-tumor efficacy in the presence of NK cells, indicating that this platform should be widely applicable to the development of various allogeneic CAR-T cells." Keji Pharmaceutical told Caixin reporters.
According to Precedence Research data, the global CAR-T cell therapy market reached $3.827 billion in 2022 and is expected to reach $88.528 billion by 2032, with a compound annual growth rate of 29.8%.
Given such outstanding clinical data, does Keji Pharmaceutical have plans to go global in the future? Keji Pharmaceutical responded to Caixin reporters, "We have a positive attitude towards the internationalization of the company's CAR-T and will continue to explore opportunities in the international market to enhance the company's competitiveness in the global innovative cell therapy field, striving to make innovative and differentiated CAR-T products benefit global patients."
It is worth mentioning that in the recent medical insurance negotiations in 2024, Keji Pharmaceutical's Zevokeozen injection (CT053), which was listed in March this year, appeared in the list of drugs reviewed in form, but unfortunately, according to Caixin reporters' on-site observation, the four CAR-T varieties, including Zevokeozen injection, seemed not to have entered the national negotiation stage.
Some industry experts told Caixin reporters, "Whether CAR-T drugs can be included in medical insurance depends on two factors: the willingness of companies to lower prices and the willingness of medical insurance to show bias towards innovative drugs."
