How many years has it been since the patent cliff?

At the same time, in July, after the Evaluation Center of the State Pharmaceutical Products Administration issued the Notice on Public Soliciting Opinions on the Guiding Principles of Clinical Research and Development of Anti-tumor Drugs for Clinical Value, the orders of CRO/CDMO enterprises were affected, and their stock prices fell in succession. What will happen to the industry after the formal implementation of the Guiding Principles?

Earnings doubled, and several companies made outstanding achievements.

16 In August, the semi-annual report submitted by Gloria Ying showed that the profit doubled in the first half of the year, and the revenue1760 million yuan was realized during the reporting period, up by 39.04% year-on-year, and the net profit was 429 million yuan, up by 36.03% year-on-year. As a CDMO company, Gloria Ying accelerates the clinical research and commercial application of innovative drugs by providing one-stop CMC services, R&D and production services to domestic and foreign pharmaceutical companies and biotechnology companies throughout the drug life cycle.

CRO refers to the outsourcing service of drug research and development, including pre-clinical and clinical research stages. Generally speaking, faced with the high cost of drug research and development, some large pharmaceutical companies choose to outsource some non-core R&D links, which can save 30%-50% of the cost while improving efficiency.

In the field of CRO/CDMO, it is not only Gao Liying who handed over the brilliant semi-annual report. The semi-annual report disclosed by Wuxi PharmaTech last week showed that during the reporting period, the revenue was 654.38+0.0537 billion yuan, up 45.70% year-on-year, and the net profit was 2.675 billion yuan, up 55.79% year-on-year. WuXi PharmaTech's main business covers CRO, chemical drug CDMO, cell and gene therapy CTDMO (contract testing, R&D and production) and other fields. During the reporting period, the high prosperity of CDMO business, the growth of clinical research and other CRO services became the key to promote performance.

The first half performance forecast from Kanglong Huacheng shows that during the reporting period, the estimated revenue is 31.1.400 million yuan to 3.334 billion yuan, up 42%-52% year-on-year, and the estimated net profit is 498 million yuan to 594 million yuan, up 4%-24% year-on-year.

The performance of employees is closely related to the overall improvement of the industry. Innovative drug research and development has the characteristics of high investment, long cycle and high risk. Under the double squeeze of low R&D return rate and patent cliff, promoting R&D projects through external R&D service organizations can improve R&D efficiency and reduce R&D costs, which has become the same choice for many enterprises. 202 1 latest frost &; Sullivan Report predicts that the global R&D investment in pharmaceutical industry will increase from $224 1 billion in 2026 to $3 129 billion in 2026, with a compound annual growth rate of about 6.9%.

Drug test center "guides" tumor drug research and development

The field of cancer drugs has always been an important field of new drug research and development, and many enterprises have invested heavily. Just recently, a news about the research and development of anti-tumor drugs caused a sensation in the industry.

On July 2nd, the Drug Evaluation Center (CDE) of the State Administration of Pharmaceutical Products issued the Guiding Principles for Clinical Research and Development of Antitumor Drugs Oriented by Clinical Value (draft for comment). The Guiding Principles point out that the research and development of anti-tumor drugs in China is in a stage of rapid development; The research and development of anti-tumor drugs, from determining the research and development direction to carrying out clinical trials, should carry out the concept of taking clinical demand as the core and carry out clinical value-oriented anti-tumor drug research and development.

It is generally believed that the above guiding principles directly reduce the possibility of listing me-too drugs (with independent intellectual property rights, and the efficacy is equivalent to similar breakthrough drugs), which will further reduce the number of orders received by CRO/CDMO enterprises.

In the first half of this year, Wuxi PharmaTech has provided services to more than 5,220 customers (active customers) in more than 30 countries around the world. In the business layout of Gloria Ying, the revenue in Chinese mainland in the first half of the year was 1.9 1 billion yuan, accounting for 1.86% of the revenue in the same period. Business from abroad is the most important part of its income, reaching 1.569 million yuan in the first half of the year, up 8.9 1.4% year-on-year, with a gross profit margin of 3.766.

At the same time, the proportion of pharmaceutical R&D outsourcing in China continues to increase, and Frost &; Sullivan Report predicts that the proportion of pharmaceutical R&D outsourcing in China will increase from 39.4% in 20021year to 49.9% in 2026.