[헬스코리아뉴스 / 이순호] Celltrion, which surprised the world with the birth of the world’s first biosimilar in Korea, which was a barren land for the bio industry in 2012, is spurring preparations for new foods. The fields are diverse, from chemical drugs to new biologic drugs and vaccines, and the rapid pace of business is raising expectations for the emergence of a new cash cow that will succeed biosimilars.
Celltrion received approval from the Ministry of Food and Drug Safety on the 17th for a phase 3 clinical trial plan for a combination therapy of high blood pressure drug ‘Idalbi’ (azilsartan medoxomil) and another high blood pressure ingredient ‘amlodipine besylate’.
This is to evaluate the efficacy and safety of the combination therapy of the two drugs in patients with essential hypertension who do not respond adequately to the monotherapy of ‘Idalbi’ and ‘amlodipine besylate’. do.
‘Edalbi’ is a new high blood pressure treatment developed by Takeda Pharmaceutical. Celltrion acquired 18 ‘Primary Care’ chemical drug businesses in the Asia-Pacific region from Takeda Pharmaceutical in June last year for a total of $278.3 million (about 307.4 billion won), including ‘Edalbi’ done.
Celltrion is currently developing various complex drugs using ‘Edalbi’. The company previously received approval for a phase 1 clinical trial plan for ‘CT-L08’ and ‘CT-L09’ based on ‘Edalbi’ in July and started testing.
‘CT-L08’ is a two-agent combination drug that adds ‘Rosuvastatin’, a hyperlipidemia treatment ingredient, to ‘Edalbi’. It is a three-agent combination drug that combines ‘B’. The company aims to complete phase 1 clinical trials for these two combination drugs within this year.
Celltrion is also developing new chemical drugs. Completed phase 1 clinical trial on ‘CT-G20’ (main ingredient ‘S-cibendazole’), a new drug candidate for hypertrophic cardiomyopathy (HCM), which is being developed as the company’s first chemical drug, and is currently undergoing phase 1b clinical trial on patients is in progress
The safety and tolerability of ‘CT-G20’ was confirmed in the phase 1 clinical trial on healthy subjects, and some data to predict the efficacy of ‘CT-G20’ were secured and commercialized in the phase 1b clinical trial on patients. raising expectations for
Transformation from biosimilar to biopharmaceutical developer
Development of new anti-viral blocking antibody drug and new technology anti-cancer drug
Celltrion is also in the midst of developing new biopharmaceuticals. In particular, it has been reborn as a biosimilar developer from a biosimilar developer as it recently received official approval for the novel coronavirus infection (COVID-19) antibody treatment ‘Rekkorina’ (legdanvirab) in Europe.
In addition to ‘Rekkorina’, Celltrion’s new biologic drug that Celltrion is currently working on the most is ‘CT-P27’, a new comprehensive influenza antibody drug.
‘CT-P27’ is a complex antibody treatment consisting of two antibodies, and the antibody binds to the axis of hemagglutinin, a surface protein of the virus, and prevents the virus genome from penetrating into the cell. The hemagglutinin axis is characterized by no mutation. Therefore, ‘CT-P27’ is expected to be effective in the treatment of most flu, including various epidemics and seasonal flu, regardless of whether the virus is mutated or not.
The company recently started developing anticancer drugs using antibody drug conjugate (ADC) platform and messenger ribonucleic acid (mRNA) platform technology.
The ADC platform is a technology that combines an antibody that functions as a guided missile with a drug that acts as a bomb to precisely strike cancerous tumors. Celltrion aims to develop high-performance anti-cancer drugs by applying ADC platform technology to its anti-cancer biosimilars. .
Celltrion is also developing a messenger ribonucleic acid (mRNA) platform with U.S. Trilink Biotechnology. It is known that this technology will be used to strengthen the anticancer drug pipeline rather than develop a vaccine against the COVID-19 mutant virus. This is interpreted as a stepping stone to preoccupy the market by actively jumping into the development of mRNA-based anticancer drugs that global pharmaceutical companies are eyeing.
“Making antibodies means being able to make antigens”
Vaccine business top surface … Rightsization work ‘tacking’
“Making antibodies means being able to make antigens. (COVID-19) Antigen development has already been completed. If necessary, we will jump into the development of a COVID-19 vaccine.”
Celltrion Honorary Chairman Seo Jeong-jin said this at an online press conference held in February this year. It was a remark that meant that Celltrion, a developer of antibody therapeutics, also possesses vaccine development technology.
In fact, Celltrion has been promoting the vaccine business for over 10 years. However, it was still in the search stage, pushed by other businesses such as antibody treatments and chemical drugs, but as the company recently started to focus on vaccine development, the related business seems to be gaining momentum.
The company reorganized its R&D organization this year, created a ‘Bio New drug’ department, and assigned a vaccine R&D mission along with discovering new biologic drugs. Vaccine R&D work has been assigned to the ‘R&D Management’ department and carried out along with project management, research support, non-clinical research, and cosmetic development. It is evaluated that this reorganization has increased the concentration of work as the biopharmaceutical development department is in charge of vaccine development.
In conjunction with the reorganization of the R&D organization, Celltrion’s vaccine business also began to accelerate. Celltrion applied to the Korean Intellectual Property Office for technologies related to shingles and pneumococcal vaccine compositions in March and July of this year, respectively. Celltrion’s vaccine pipeline known so far was almost the only one for influenza vaccine ‘CT-P25’, but as Celltrion started working on the rights to a new vaccine candidate, the outline of the follow-up pipeline was revealed.
As a result of checking the patent application specifications of this paper, the shingles vaccine being developed by Celltrion not only significantly increases the virus-specific cell-mediated immune response, but also makes the immune response faster and stronger than existing vaccines, and the effect lasts for a long time. do.
The pneumococcal vaccine can induce immune responses to more diverse serotypes than Pfizer’s pneumococcal vaccine ‘Prevena 13’. In particular, unlike ‘Prevena 13’, which is designed mainly for serotypes that appear mainly in Europe and North America, 6 serotypes prevalent in Europe and North America as well as throughout Asia are added, so it is expected to be available in more countries.
An industry official said, “Celltrion is accelerating the discovery of new foods based on its strong cash cow called biosimilars. It is noteworthy whether the new business field will be able to achieve astonishing results as it is now.”
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