He Ruyi, Chief Medical Officer of Rongchang Bio: It is difficult to innovate the internationalization of innovative medicines.

Since the reform of the drug review and approval system in 2015, the development of the domestic innovative drug industry is changing with each other. In the end of 2021 in the new crown epidemic, the frequent innovation policies, and the transformation of the international situation, it has reached the inflection point of differentiation.

Here, internationalization is an important test of inspection enterprises' innovation. Rongchang Bio (SH688331, a stock price of 54.55 yuan, and a market value of 29.690 billion yuan) appeared in a dark horse. In 2021, its first domestic ADC drug received an olive branch thrown from the international ADC leader. With a down payment and milestone payment up to 2.6 billion US dollars (plus the gradient from high to 15 % from high digits to more than 15 %, gradients of more than 15 % were gradient to more than 15 %. The exclusive license agreement of sales of sales) once set the highest record of Chinese pharmaceutical companies' single medicines to go to sea.

The former chief scientist of the State Drug Administration and the former FDA (US Food and Drug Administration) clinical review and approval expert He Ruyi joined Rongchang Biology as chief medical officer in 2021, and insight into the sea in the cloudy change of domestic industries.

On August 18th, international conferences of 2022 Pharmaceutical Innovation and Development were held in Yantai. From the perspective of registration and clinical clinic, He Ruyi shared his views on the international strategy and risk control of innovative drugs.

Photo source: organizer confession

The first and secondary markets are unknown. Aiming at the international market is a must -have

In July last year, the "Principles of the Clinical R & D Guidance of Anti -tumor Drugs with clinical value" triggered the cold thinking of innovation in the industry. In the context of frustration and epidemic raids, the Chinese innovative drug industry that was surrounded by capital for 5 years was Began to taste the cold taste of financing.

Taking the Science and Technology Board as an example, Ping An Securities August Research Report shows that the science and technology board innovation pharmaceutical companies listed in 2022 have broken through the day of listing. In the case of recent investment in investment heat, more than 60%of companies are still in low low companies. In the state of the issuance price.

It is worth noting that the innovative drug market enters the trough period, and the chassis adjustment takes a certain period of time. The industry's prediction of this period of financing has no clear consensus.

Faced with the phenomenon of upside -down prices of China's innovative pharmaceutical industry, and even the valuation of some companies approaching the company's handheld cash volume, how Ruyi believes that this has exceeded the scope of conventional "callback". In addition to the investment bubble, the investment time difference between the first- and secondary markets and the changes in the expected expectations of innovative drugs in the secondary market are the reason why the investment environment of domestic innovative drug companies is cold.

He Ruyi quoted McKinsey's investigation in 2021 that the policy environment, corporate financing, research and development capabilities, innovation results, and international standards are key factor affecting the Chinese pharmaceutical innovation index.

In the past few years, the domestic innovative drug industry has made significant progress in financing, research and development, and internationalization. The market access under the policy environment has also improved with dynamic adjustment of the medical insurance directory, but innovative drugs still lag behind other dimensions in the reimbursement of medical insurance reimbursement in other dimensions. Essence

He Ruyi said that in the next 5 to 10 years, the medical insurance policy positioned in "Basic" and "improving the masses' medication" may still be one of the important issues that need to be faced in the development of the domestic innovative drug industry. In the future, domestic innovative drugs Other payment parties are introduced in market access. The intensive emergence and scope of concentrated band procurement has pushed domestic pharmaceutical companies to the runway of innovation, and adherence to the differentiated and international routes can regain prosperity.

"Our company should adjust according to our own situation. It is not necessarily lowering the goal, but at least adjust our direction."

Why Ruyi suggests, whether it is Biotech (biotechnology company, mainly research and development) or BioPharma (biopharmaceutical company, integrates research, production, and sold out). The current primary problem is to survive, and then consider how to live better better. Essence Specifically, in the past, wide, multi -and -long product pipelines needed to be appropriately subtracted. Enterprises should focus on limited funds on superior products to improve the company's technical platform competitiveness.

In addition, running in the industry cycle fluctuation, the direction of internationalization is clearer.

According to He Ruyi, in the next 10 years or longer, the internationalization of China's pharmaceutical innovation market is still one of the most important development directions.

The internationalization of China Innovation Pharmaceuticals is "three steps". How should I take the next step?

According to the data displayed by He Ruyi, the number of transactions of China Innovation Pharmaceutical Cross-border License-OUT (authorized transaction) in 2021 was 53, less than 72 in 2020, but the total transaction amount was 14.5 billion US dollars, which was higher than 12.5 billion US dollars in 2020 Essence A single transaction amount was US $ 270 million, and the down payment was 32 million US dollars, which was significantly improved from previous years.

Among them, there are many out -of -sea projects represented by emerging Biotech, and the transaction amount is quite high. The projects are mostly concentrated in the field of tumors. Rongchang Biological and Seagen's anti -authorized transaction volume on Vidico alone ranks among the top ten in the world.

However, He Ruyi believes that the internationalization of China Innovation Pharmaceuticals is still in the first stage, that is, the License-in (authorized introduction)/License-OUT driven by product authorization. The second stage of internationalization is that the product enters the international multi -center confirmation clinical trial, and the third stage is the international marketing of international pharmaceutical companies.

At present, the international pharmaceutical leader represented by Pfizer and Astraikon has reached the third stage. Only in this stage can we establish a marketing team to sell products in various countries around the world.

With 17 years of experience in participating in clinical review and approval in the FDA and long -term insights on the industry, how Ruyi emphasizes that Chinese pharmaceutical companies want to promote products to go to sea. The first requirement is to understand the regulatory requirements of local countries. On the basis of the core of new drug research and development, make full use of the regulatory flexibility policies to connect fast channels such as "breakthrough therapy". Secondly, strengthening communication with regulatory agencies is by no means a common talk, but a common talk. He Ruyi warned the enterprise not to take the FDA registration approval lightly. If there is no clear meeting minutes, there is no determined FDA rules guidelines, a FDA official's statement at a certain time and occasion is not enough for corporate decision -making.

"Be sure to do international planning as soon as possible. The earlier the concept of multi -center multi -center, the better." He Ruyi appealed that domestic innovative pharmaceutical companies should correct the understanding of international clinical trials. The initial clinical trial design was even launched before the product did not enter the clinic.

From the perspective of expenses and clinical control, enterprises can consider early exploration tests in China. After phase II clinical clinical clinical to the United States or international clinical bases, in order to communicate the test data with international companies.

In addition, differentiated clinical trial design, respecting the laws of new drug research and development, and avoiding the last two suggestions for how Ruyi Ruyi is to domestic innovative pharmaceutical companies.

Taking the Vidicu monopoly of Rongchang Bio as an example, how Ruyi said that he could get the "breakthrough nature of the State Drug Administration)" breakthrough in the field of the National Drug Administration) in the field of fierce competition and densely developed breast cancer in June last year. The main reason is that the R & D team has adjusted the clinical trial design to "patients with advanced breast cancer in HER2 positive presence of liver metastasis". This patient's group condition is even more serious, and clinical needs are greater, so that drugs can be differentiated in the field of "tie" in the development of "tie".

Daily Economic News

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