News Center
Zhuhai Special Zone Daily: Lijun's original innovative drug moves towards international cutting-edge.
Release time:
2015-03-10
Zhuhai Special Zone Daily: Lijun's Original New Drug Moves Towards International Cutting Edge
Just over two years after introducing the core innovation team for monoclonal antibodies from overseas, Livzon Pharmaceutical Group's first monoclonal antibody under research—a Class I new drug injection of recombinant humanized anti-tumor necrosis factor α monoclonal antibody (TNF-α)—has recently successfully completed Phase I clinical trials.
This is the first key battle for Livzon to accelerate its entry into the forefront of high-end biopharmaceutical monoclonal antibodies. After this Class I new drug is launched in 2018, it will break the monopoly of imported drugs and solve the accessibility of medication for the public.
At thirty years old, Livzon has sounded the horn for a new round of innovation. On the journey towards innovative drugs, Livzon has chosen a glamorous yet risky path that represents the current and future direction of international pharmaceutical development and fills the domestic pharmaceutical gap.
"The new drug we developed (TNF-α) has effects similar to the currently best-selling global brand, but it is definitely not a generic drug." On March 6, Peng Yucai, the deputy general manager of Livzon Monoclonal Antibody Company, told reporters that the molecular structure consists of a different protein sequence, which ensures that this will be an innovative drug with global patents held by Livzon.
In a situation where 95% of domestic pharmaceutical companies are developing generic drugs, the phrase "definitely not a generic drug" indicates Livzon's firm determination to move towards the international forefront through original new drugs.
As early as 1991, Livzon won the Zhuhai Million "Science and Technology Award" amidst public attention. In 2010 and 2014, Livzon won the first prize of the provincial science and technology award twice for its projects on Shenqi Fuzheng injection and the research and industrialization of the original new drug Aiprazole. At the beginning of this year, its project on the research and industrialization of the reproductive drug Urinary Follicle Stimulating Hormone (FSH) won the second prize of the provincial science and technology award.
The frequent awards are ultimately due to Livzon's precise choice and persistent adherence to the strategic direction of original new drugs. Lu Wenqi, vice president of R&D at Livzon Group, introduced that in the field of innovative drugs, Livzon has chosen key areas with the most intense international competition, the highest technical content, and that fill domestic gaps.
In recent years, antibody drugs are developing into a new category of diagnostic and therapeutic agents in the international pharmaceutical market due to their high specificity, effectiveness, and safety. Data shows that among the top ten drugs in global sales in 2012, six were monoclonal antibody drugs. In recent years, Livzon has gradually implemented a strategic transformation from chemical pharmaceuticals to biopharmaceuticals, positioning monoclonal antibody drugs as its main products in the biopharmaceutical field.
In just a few years, Livzon has established an internationally advanced quality control platform for monoclonal antibody drugs and a preclinical efficacy and safety evaluation animal model platform for monoclonal antibody drugs. Currently, Livzon has seven monoclonal antibody products under research, advancing at a speed of 1-2 new products applying for clinical trials each year.
If Livzon Dele, Shenqi Fuzheng injection, Aiprazole, and other heavyweight drugs supported Livzon's development in the first thirty years, then undoubtedly, in the next thirty years, Livzon's monoclonal antibody drugs will advance into a broader blue ocean.Data from Chinese hospital terminals shows that China is in the initial stage of developing monoclonal antibody drugs, increasing at a rate of over 50% each year.
According to reports, the recently completed clinical Class I new drug injection of recombinant humanized anti-tumor necrosis factor α monoclonal antibody is primarily used for autoimmune diseases such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis.Currently, there are already three anti-tumor necrosis factor monoclonal antibody drugs on the market, with global sales of about $20 billion last year. After Livzon's new drug is successfully launched, it will elevate the quality of domestic medications in this category to align with international standards and significantly reduce treatment costs, with an initial estimate of reaching a market scale of 1 billion yuan in three years.
While continuously achieving breakthroughs in original new drugs, Livzon has also invested significant R&D efforts to further deepen previous innovative achievements. Reporters learned that after the global first launch of the Class I anti-ulcer new drug Aiprazole enteric-coated tablets in 2008, the research and development of the Class II new drug Aiprazole injection has made breakthrough progress and is currently undergoing Phase III clinical trials, expected to be industrialized and launched in 2016.
In 2009, Livzon successfully developed and industrialized China's first sustained-release microsphere preparation—injectable leuprolide acetate sustained-release microspheres. Starting in 2011, Livzon began in-depth research on common key technical issues of microsphere preparations and developed a series of new varieties. In 2013, Livzon introduced a sustained-release microsphere technology team led by Dr. Xu Peng from overseas.
It is worth mentioning that the aforementioned Aiprazole and sustained-release microspheres are emerging high-end drug formulations. Among them, sustained-release microspheres have long been monopolized by European and American pharmaceutical companies, which have implemented a technology blockade against China. As a "heavyweight bomb," the Class 1 compound innovative drug Aiprazole has been used in over 200 hospitals in the five years since its launch, with annual sales exceeding 100 million.
Behind the rapid progress of technological innovation is Livzon's strong guarantee for investment in innovation. Lu Wenqi introduced that the group invests about 5% of its sales revenue in R&D each year, with an average annual R&D expenditure of over 200 million yuan, leading the industry. It is also worth mentioning that Livzon has established an internal risk fund. "Every year 10 million yuan is allocated to encourage R&D personnel to conduct innovative research on projects with unclear prospects before project approval, activating source innovation."
In September 2010, Dr. Peng Yucai, a senior scientist at Baijian Biopharmaceuticals in the United States, resigned and returned to China, joining Livzon Monoclonal Antibody. On the day of the interview, when asked why this star figure in the biopharmaceutical industry was willing to join a new company in China that was still in its infancy, Peng Yucai said: "Working in a U.S. pharmaceutical company may just make you a screw in a large system, but returning to China, your work may drive an entire pharmaceutical industry." (Zhuhai Special Zone Reporter Liao Mingshan)
Related Information