Standardization of Clinical Trials to Upgrade New Drug CRO to Seek Strategic Transformation

Since the CFDA formally issued the “Announcement on Carrying out Self-Inspection and Verification of Drug Clinical Trial Data (2015 No. 117)” in July 2015, the upgrading of the quality of drug clinical trial supervision has had a significant impact on CRO companies in the past 2016. Big impact: the sponsor actively withdraws applications, the number of new drug application items has dropped sharply, the cost of data self-examination has increased, and the completion of questions has been slow… At present, as listed companies in various markets begin to announce annual results, the reporter found that the industry is under pressure to reshuffle Below, the strategic transformation of CRO companies is imminent.

Project Drops and Pressure Rises Sharply

Looking at the performance of listed CRO companies in 2016, Tigermed and Guangzhou Boji have released the 2016 annual performance report. Among them, Tigermed’s preliminary calculation of 2016 total operating income reached 1.204 billion yuan, an increase of 25.86% over 2015; operating profit reached 210 million yuan, a decrease of 1.57% from 2015. Guangzhou Boji initially calculated its total operating income in 2016 of 72.1845 million yuan, a decrease of 42.99% from 2015; operating profit was -6.5331 million yuan, a decrease of 123.84% from 2015.
As of press time, the three CRO companies listed on the NEEQ have not yet released their 2016 annual reports, but analysis of the semi-annual reports previously released shows that the performance difference is very obvious: Saidesheng’s operating income in the first half of 2016 was 25,076,800 yuan, A decrease of 8.86% compared with the same period of last year; net profit of 2,700,300 yuan, a decrease of 64.48% compared with the same period of last year. Aozida’s operating income in the first half of 2016 was 18.38333 million yuan, an increase of 35.89% over the same period last year; net profit was -1.6016 million yuan, an increase of 52.39% over the same period last year. Due to the consolidation of the performance of its subsidiary Yixing Wisdom, Yongming Medical’s performance has been greatly improved. After deducting the subsidiary’s operating income and net profit, the operating income of the first half of 2016 was 22,974,300 yuan, and the net profit was 2.0362 million yuan, both increased over the same period last year. .
An executive of a CRO company told reporters: “In 2016, the quantity and quality of domestic CRO company projects were generally not optimistic. It is rare to receive large orders of several million yuan. However, there are dozens or hundreds of people in a company. It is still increasing; some small and medium-sized CRO companies focusing on new drug projects have already experienced operational problems, and some CRO companies that originally planned to launch IPOs have also abandoned their plans to enter the capital market. This is due to systemic risks caused by changes in the policy environment. .”
Previously, the “2016 Drug Evaluation Report” issued by the National Center for Drug Evaluation (CDE) showed that CDE received 3779 new registration applications throughout the year in 2016, a 54% decrease from 2015, and the registration of traditional Chinese medicines, chemical drugs and biological products The number of applications received decreased; compared with the previous three years, the confirmatory clinical trial applications and ANDA in the chemical drug registration applications in 2016 were affected by the implementation of the new registration classification, and the number of received applications decreased the most, with a decrease of 80% and 69 respectively compared with 2015 %; 240 applications for the registration of innovative chemical drugs (formerly 1.1, 1.2 and new 1) were received, an increase of 18% from 2015.
In an interview with reporters, Gao Zhigang, vice president of Beijing Saidesheng Pharmaceutical Technology Co., Ltd., said frankly that the upgrading of the regulatory environment has also led to the slow progress of the trial project, because in the past year, all aspects of clinical trials have been receiving sponsors, inspectors, and Verification by provincial bureaus and the State General Administration. “On the positive side, clinical trials are more rigorous and researchers are more cautious; on the other hand, many projects that are strictly implemented in accordance with the norms have been implemented and completed slowly. For example, some projects have been able to join the group in the past month. 4 to 5 patients, only one case can be enrolled in the group within a month or two; the project progress is slow, but the personnel are still working on the project. The biggest cost of the CRO company is human resources, and the management cost has been straightened up.”

Focus on Innovation and Fine Management

If systemic risks are unavoidable, the ability to resist risks becomes the key to the survival of an enterprise. From the annual reports of the above-mentioned companies, it can be seen that device CROs were less affected by the upgrade of the regulatory environment in 2016: Aozida focuses on clinical trial projects for medical devices, while Yongming Medical focuses on the cardiovascular field and clinical trials. The project also includes many equipment businesses, and revenue and profits are relatively stable. In addition, Hangzhou Tiger, as a leading domestic CRO company, not only has domestic project lists, but also a considerable number of overseas project lists, and its industrial chain business complements and investment businesses tend to be diversified, and have strong anti-risk capabilities. .
According to analysis by Wang Shuishai, the founder of Guangzhou Haibote Pharmaceutical Technology Co., Ltd., new drug clinical practice only needs to be done in accordance with regulatory requirements and the process is relatively standardized. Therefore, new drug clinical practice has no threshold for any mature CRO company. “After the industry’s major rectification in 2016, the result is that the new drug R&D projects of pharmaceutical companies have been gradually reduced through purification. In addition, generic drugs must be evaluated for consistency, and the industry is facing the process of reshuffling; from the perspective of industrial reform, The country is removing excess capacity and the backlog of approvals. In the future, the domestic pharmaceutical industry will add more innovative drugs and post-market clinical trials.”
Obviously, the upgrading of industrial structure and international industrial cooperation and transfer will stimulate the domestic CRO industry to usher in a period of development opportunities. On the one hand, the consistency evaluation work of generic drugs is intensified, and the reshuffle of approval documents and the improvement of quality and efficacy will generate tens of billions of pharmacy and BE trials market demand; on the other hand, clinical data verification and institutional review have become normalized, and clinical trials are standardized. Sexual upgrading will reshape the domestic CRO ecology.
The new market environment is also pushing clinical trials to return to their origins of scientific and ethical values. The above-mentioned CRO company executives stated that the professional qualities of management personnel of many clinical trial institutions are also growing rapidly, and clinical experts are already very familiar with the requirements of trial specifications. Therefore, CRA does not have strong business capabilities, knowledge and accomplishments, and the pressure of clinical trial work will be very high. Big. “These are all testing the strategic decisions of CRO companies. Relying on business transformation, reorganization, and integration to make rapid adjustments, strengthening refined project management is particularly important in the new era.”
Gao Zhigang further pointed out that the approval documents for the past three types of drugs are now significantly reduced, and there are more and more innovative drugs. The sponsors are no longer overly compressed project budgets as in the past, so the project costs are much higher than in the past. At the same time, due to the sharp decrease in the number of project declarations of domestic companies, they will inevitably pay more attention to the “surviving” projects and increase investment, and the project quality requirements will increase accordingly. “If you want to achieve standardized clinical trials under the new regulatory environment, the cost will inevitably rise. Therefore, it is not that the cost is high now, but that the cost was too low in the past. In the past, a project manager or CRA was responsible for five or ten projects at the same time. The situation certainly cannot adapt to the current regulatory environment.”