The "Four Revolutions" of pharmaceuticals: The Singularity and the birth of Kings on the road to new drug development

In 1986, the first anti-tumor biotech drug alpha-interferon (Intron A) came to market, from Merck, Germany;

In 1990, the first personal-source antibody preparation technology was established;

In 1997, Rituxan, the first therapeutic targeted antibody, came to market from Roche.

In 1998, the first tumor therapy targeted antibody Herceptin (Herceptin) came to market, from Roche;

In 1998, Amgen's Neupogen was launched and became the first blockbuster biotech drug (annual sales of more than $1 billion).

In 2001, Novartis' Imatinib (Gleevec) was launched and is considered to be the first targeted drug for tumor therapy

In 2002, the first fully human monoclonal antibody drug Humela (adalimumab) was approved for market, and the annual sales of more than 20 billion US dollars was born.

Target-based pharmaceutical, the requirements for clinical research has also been further highlighted.

In the process of new drug development, clinical research can confirm or reveal the effects of experimental drugs, adverse reactions, etc., is an important way to judge whether a new drug can be used for treatment, and has become the stage with the highest cost of time and money.

During the flourishing period of chemical drugs in the 19th century, the clinical trials of various pharmaceutical manufacturers were in separate affairs without unified supervision. At this time, clinical trials were mainly regulated at the level of ethics and morality.

With the formal establishment of the FDA in 1930, the parallel of ethics and regulations became the industry standard, and the clinical trial teams of various pharmaceutical companies began to standardize. Among them, Merck is at the forefront of clinical trials.

In 1933, Merck's research laboratory was established in Rahway, New Jersey, covering the full range of functions from basic research to clinical trials, which may be an important cornerstone of its new drug development.

In early October 1941, during World War II, four companies - Merck, Pfizer, Squibb and Lederle Laboratories - held a secret meeting with U.S. government experts at the Carnegie Institution to discuss the possibility of growing penicillium and extracting penicillin.

In March 1942, less than five months after the project began, the Medical Research Board first approved Merck's penicillin clinical trials. It provided an important basis for the mass production of penicillin.

Since then, the importance of clinical trials has aroused further attention from various pharmaceutical manufacturers, including Eli Lilly and Pfizer;

In 1934, Lilly opened two new facilities in the McCarty Street building: a replica of Lilly's 1876 laboratory and the new Lilly Research Laboratory, which was "one of the most well-equipped facilities in the world."

In 1950, Pfizer discovered oxytetracycline (the first antibiotic it independently discovered), marking its transition from a fine chemical manufacturer to a research-based pharmaceutical company, and officially launched its research laboratories.

In 1960, Pfizer moved its medical research laboratory operations from New York City to a new facility in Groton, Connecticut.

The soaring cost of research and development and the focus on clinical research have also led to the birth of a new form of the pharmaceutical industry CRO (pharmaceutical research and development contract outsourcing service).

From the early 1980s, with the development of modern biotechnology, target-based drug research and biopharmaceutical began to flourish, so that the overall development costs soared, the average cost of new drug research and development in the United States rose from $138 million in 1975 to $802 million in 2000.

In 1982, Quintiles, the first modern commercial CRO, was founded.

The profits are thinner, but the risks are bigger. In order to manage the drug development process more effectively, and to reduce costs and maximize profits, large pharmaceutical companies and biotechnology companies are beginning to consider contracting clinical research to CRO enterprises, providing a niche market for the development of CROs.

Beginning in the late 1990s, the CRO service market began to grow explosively, rising from 4% in the early 1990s to 50% in the mid-2000s.

03, the human genetic code "cracked", pharmaceutical companies into the era of translational medicine

In 2000, the sketch of the human genome was drawn, representing the initial success of the exploration of the human genome, and laying the foundation for precision medicine thereafter.

Since then, on the basis of this technology, the precision efficacy of drugs has been more patient-centered, and it is more aware that many new drugs have a certain disconnect with the clinic in basic research, which has increased the failure rate in the clinical trial stage. The concept of "translational medicine" was introduced at this turning point.

Translational Medicine is known as the last mile of new drug discovery.

The purpose is to combine basic research and solve the practical problems of patients, and its basic feature is multidisciplinary cooperation, in-depth basic research for clinical problems, so that the research results can be applied quickly. From the laboratory to the bedside.