First in Class, or First Innovative Medicine, is the first drug with a new mechanism that can treat a disease
.
Since the CDE issued the "Clinical Value-oriented Clinical Research and Development Guidelines for Anti-tumor Drugs", a new policy to combat "pseudo-innovation" on November 19, 2021, domestic pharmaceutical companies have increased their R&D investment, continuously improved their independent research and development capabilities, and potential first in class/Best in class innovative drugs oriented to clinical value are emerging
.
Recently, Junshi Bio replied to investors on the interactive platform that the company's existing product pipeline is expected to become first-in-class drugs, including JS004 (anti-BTLA monoclonal antibody), JS009 (anti-CD112R monoclonal antibody), JS014 (IL-21 fusion protein) and JS113 (fourth-generation EGFR inhibitor) and so on
.
According to reports, JS004 is the world's first recombinant humanized anti-BTLA monoclonal antibody
specifically targeting B and T lymphocyte attenuation factor (BTLA) that has entered the clinical development stage of the company's independent research and development.
As of now, JS004 has entered the Ib/II phase of dose expansion
.
The company is conducting a combination trial of JS004 and terreprimumab in multiple tumor species in China and the United States to exert synergistic antitumor effects
.
JS009 (anti-CD112R monoclonal antibody) is a recombinant humanized monoclonal antibody targeting CD112R independently developed by the company for the treatment
of advanced malignant tumors.
JS009 is expected to further promote T cell activation and improve clinical treatment effect
by combining JS009 with the company's self-developed specific anti-TIGIT monoclonal antibody (JS006) and terreprimumab.
The company plans to actively explore combination drugs in the follow-up to maximize the synergistic anti-tumor effect
of self-developed products.
The active ingredient of JS014 is recombinant interleukin 21-anti-human serum albumin (HSA) single-domain antibody fusion protein, and the half-life of IL-21 is significantly extended
by fusing single-domain antibody against HSA.
In addition, JS014 in combination with immune checkpoint monoclonal antibody exhibits strong synergistic antitumor activity
.
JS113 is a fourth-generation EGFR (epidermal growth factor receptor) inhibitor intended for the treatment
of EGFR-mutated non-small cell lung cancer and other solid tumors.
Preclinical data showed that the drug molecule was insensitive to third-generation EGFR inhibitors with primary and acquired EGFR mutations (including Del19/T790M/C797S and L858R/T790M/C797S co-mutations), as well as some TKI-resistant bypass activation targets and immunosuppressive targets, and had high selectivity
for wild-type EGFR.
It is understood that the first-in-class drug has always been the focus
of research and development of Junshi Biologics.
Behind its rich product line, it is inseparable from the company's continuous R & D investment
.
In the first half of this year, Junshi Bio invested about 1.
062 billion yuan in research and development, and the total R&D expenditure accounted for 112%
of revenue.
In addition to Junshi Biologics, there are also a large number of local pharmaceutical companies in China, such as Yusen Jianheng, Hualing Pharmaceutical, East China Medicine, Microchip Biologicals, Legend Biologicals, Inming Biology, Hehuang Biologicals, Junshi Biologicals, Hengrui Pharmaceuticals, etc.
are actively deploying in the field of First-in-class research and development, of which East China Pharmaceutical Strategic Planning to achieve internationalization in 2030, the basic requirement of internationalization is that the company must have global rights and interests of FIC or BIC products to achieve product technology dimension reduction strikes.
In recent years, the company is accelerating the layout
of First-in-Class innovative biologics through authorized introduction.
Tianfeng Securities once said in a research report that as far as the research and development trend of First-in-class is concerned, the development conditions are mature and the prospects are broad
.
Although FIC drug research and development has high costs, long cycles and other risks, once successfully listed will bring high profits to enterprises, so FIC is an important research and development strategy
for large pharmaceutical companies.
China's innovative pharmaceutical companies have sufficient technical preparation and R&D funds, national policy guidance is gradually clear, and the conditions for the transformation to FIC strategies have become mature
.
