[헬스코리아뉴스 / 박민주] The new drug that major multinational pharmaceutical companies are most painstakingly developing is a lymphoma treatment (anti-cancer drug), it has been found. This is the part where you can read the trend of new drug development in the global market.
This is the result of analyzing the status of all clinical trials approved by the Ministry of Food and Drug Safety in 2021. A total of 1,350 clinical trials were approved last year, of which 203 were the final phase 3 clinical trials.
As a result of analyzing 203 phase 3 clinical trials, clinical trials targeting lymphoma patients (12 cases) were the most common. There are many different types of lymphoma, but the prognosis of patients is poor, so there is a high demand for new drugs. This is why multinational pharmaceutical companies are especially passionate about developing anticancer drugs for lymphoma.
Companies that are most active in developing lymphoma anticancer drugs in 2021 Roche Koreait was In December and June of last year, the company launched three ‘Mosunetuzumab’, ‘Polatuzumab Vedotin’ in July, and ‘Glofitamab’ in February. Four phase 3 clinical trials for the drug were approved.
‘Mosunetuzumab’ is a bispecific immunotherapy that targets the CD20 antibody on the surface of B cells and the CD3 antibody on the surface of T cells. Phase 3, approved in December, will be conducted on patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma.
‘Polatuzumab vedotin’ is an antibody-drug conjugate (ADC) drug that binds to CD79b expressed in B cells and induces cell death. In October 2020, it was approved in Korea under the name of ‘Polivy’. Phase 3 subjects, approved in July, are patients with relapsed/refractory diffuse large B-cell lymphoma.
Clopitamab is a bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells. It is administered to patients with relapsed/refractory diffuse large B-cell lymphoma.
A subsidiary of Eli Lilly Loxo Oncology(Loxo Oncology)’s ‘Pirtobrutinib’ (LOXO-305) has been approved for 4 phase 3 clinical trials (March, July, September, and October) in one year. Pyrtobrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor. All relevant clinical trials are conducted by IQVIA Korea, a clinical trial consignment agency.
The clinical subjects of ‘pirtobrutinib’ were: ▲ patients with chronic lymphocytic leukemia/small lymphocyte lymphoma who had previously been treated with a BTK inhibitor ▲ patients with mantle cell lymphoma who had not previously been treated with a BTK inhibitor ▲ patients with previously treated chronic Patients with lymphocytic leukemia/small lymphocyte lymphoma ▲ Patients with untreated chronic lymphocytic leukemia/small lymphocyte lymphoma, etc.
German pharmaceutical company Morphosis(Morphosys) received approval for the phase 3 clinical trial of ‘Tafasitamab’ (Tafasitamab, MOR208) through INC Research South Korea and Novotech Asia Korea, respectively, in March last March.
INC Research South Korea is targeting patients with relapsed/refractory (R/R) follicular lymphoma grades 1-3a or R/R marginal zone lymphoma, while Novotech Asia Korea is targeting newly diagnosed diffuse large B-cell lymphoma (DLBCL). Clinical trials are conducted in high-intermediate and high-risk patients, respectively. ‘Tafacitamab’ is a humanized monoclonal antibody that targets CD19, and has recently been designated as an orphan drug by the Ministry of Food and Drug Safety.
United States of America Seattle Genetics and Japan Takeda PharmaceuticalUnited States, a subsidiary of Millennium jointly developedBrentuximab Vedotin (SGN-35) was also approved for phase 3 in January last year. The trial is being conducted by Pharmaceutical Research Associates Korea, a clinical trial agency, and is intended for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
‘Brentuximab vedotin’ is an antibody-drug conjugate (ADC) that targets CD30. It is an anticancer drug that connects an anti-CD30 monoclonal antibody and ‘auristatin’, an apoptosis agent. In 2013, it was approved and marketed in Korea under the name of ‘Acetris’.
In addition, the US MEI PharmaZandelisib, an oral selective PI3K delta (PI3Kδ) inhibitor being developed by , was approved for a phase 3 clinical trial in June through Parexel Korea, a clinical trial commission. The subject was a patient with relapsing indolent non-Hodgkin’s lymphoma (iNHL).
Pharmaceutical companies’ enthusiasm for developing lymphoma treatments is also reflected in the status of new drug approvals. A total of 40 drugs were approved as new drugs by the Ministry of Food and Drug Safety last year, and 5 of them were drugs related to lymphoma.
These drugs are ▲AstraZeneca Korea’s Calquence (ingredient name Acalabrutinib, approved in February) ▲Servier Korea’s Oncaspar (Ingredient name: Pegaspargase, approved in February) ▲ Novartis Korea’s ‘Kymria’ (KYMRIAH, ingredient name tisagenlecleucel, approved in March) ▲ Antenjin’s ‘Xpovio Tablet’ (Xpovio, ingredient name: Selinexor, approved in July) ▲ Ono Pharmaceutical Korea’s ‘Bee’ Rexbru Tablet 80mg’ (Velexbru, ingredient name tirabrutinib, Tirabrutinib, approved in November), etc.
All domestic clinical trials conducted by multinational pharmaceutical companies are multinational clinical trials conducted by the head office, and no domestic pharmaceutical company started phase 3 anticancer drugs for lymphoma last year. Lymphoma-related clinical trials approved by domestic pharmaceutical companies include Curocell’s ‘CRC01’ Phase 1/2 (February), ImmuneOncia’s ‘IMC-002′ Phase 1 (March), and Mito Immune Therapeutics’ ‘MIT-001′ LP’ phase 2a (March) and Abclone’s ‘AT101’ phase 1/2 (December) were 4 cases, and it was an early stage clinical trial.
An official from a small pharmaceutical company said in a phone call with Health Korea News on the 4th, “If you look at the new drugs being developed by multinational pharmaceutical companies, you can read the recent drug development trends in the global market.” Development is still a solo stage for multinational companies, but as domestic companies are also increasing their investment in R&D, I think that competition will be possible in the next five years or so.”
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