On July 1, Fosun Kate registered and launched a single arm, multicenter, open phase II clinical trial of FKC889 for the treatment of recurrent / refractory mantle cell lymphoma (MCL). Fkc889 is a CD19 targeted car-t cell therapy. This is the first clinical launch of this drug in China.
Fkc889 was approved for clinical use in China on March 2 this year. Fosun Kate’s previous announcement disclosed that the drug is tecartus, a CD19 targeted car-t therapy introduced from kite Pharma, which has been approved by FDA for listing ® Drugs that are industrialized and commercialized in China.
Tecartus, July and December 2020 ® It has been approved by FDA and EU respectively. Tecartus ® At present, it is the first and only car-t cell therapy approved for the treatment of adult patients with recurrent refractory mantle cell lymphoma. At present, tecartus ® It has been approved for listing in 33 countries and regions around the world. In the United States, tecartus ® It has been awarded breakthrough drug qualification (BTD), priority drug qualification (prime) and orphan drug.
The listing approval of tecartus in FDA and EMA is based on the results of zuma-2, a single arm, multi center and open key clinical trial. As of December 31, 2019, with a median follow-up of 17.5 months, the objective response rate (ORR) was 92%, of which the complete response (CR) rate was 67%. Among all patients with assessable efficacy (n=60), 48% were still in continuous remission at the end of the data. In all patients (n=68), the incidence of CRS of grade 3 and above cytokine release syndrome was 15%, and the incidence of neurotoxicity of grade 3 and above was 31%.
In addition, in October 2021, tecartus was also approved for the second indication for precursor B-cell lymphoblastic leukemia. In 2021, its sales volume was 176million US dollars.
Mantle cell lymphoma (MCL) is a rare subtype of invasive non Hodgkin lymphoma (NHL) derived from B cells. It is caused by cell carcinogenesis in the mantle region of lymph nodes and is common in men over 60 years old. MCL is highly invasive after recurrence.
In China, the incidence rate and prevalence of NHL are 6/105 and 16/105 respectively, and the number of cases of MCL accounts for 4.63% of NHL. Therefore, the actual incidence rate and prevalence of MCL in China are about 0.27/105 and 0.74/105. However, the recurrence of mantle cell lymphoma is almost common, and many patients may receive multi-line treatment throughout their lives. The 5-year survival rate after recurrence is 27%, which is significantly lower than that of other lymphoma subtypes.
Fosun Kate is a joint venture between Fosun Pharmaceutical and kite Pharma, focusing on car-t cell therapy. In June, 2021, the company introduced the first car-t therapy in China, and yescarta injection was approved for listing; In August, a new indication was approved for clinical treatment of relapsed or refractory inert non Hodgkin’s lymphoma after receiving second-line or above systematic treatment, including follicular lymphoma (FL) and marginal zone lymphoma (MZL). This indication was then included in the breakthrough treatment program.
It can be seen from Geely De’s 2021 annual report that yescarta currently leads the CD19 car-t track with an annual sales of $695million, and tecartus also sold $176million, with an increase of more than 20% for both. It is expected to continue to rise in the future. In China, it is believed that the market scale of car-t therapy will gradually increase with the expansion of medical institutions.