Observation of pharmaceutical companies ｜ The authorization project has doubled. Can License-OUT become the main channel for "going to the sea" for domestic innovative drugs?

The 21st Century Business Herald reporter Ji Yuanyuan reported that in recent years, with the continuous enhancement of domestic medical innovation strength, the speed of innovative products entering clinical trials and approval is also accelerating. rising.

According to Pharmaceutical Rubik's Cube data, only 10 cases of Chinese companies live out of 2016 were only 10 cases, and the disclosed transaction amount was only $ 320 million. By 2021, 53 Chinese companies License Out incidents had a transaction amount of $ 14.49 billion. In addition, in the first half of 2022, a total of 28 License Out projects were reached, including 20 innovative drugs/new technology trading projects. The total transaction amount reached US $ 5.67 billion.

Among them, some heavy transactions also occur frequently. For example, Baiji Shenzhou and Novartis have reached cooperation with Overseas Rights Anti-TIGIT monoclonal anti-anti-resistance (Anti-TIGIT monoclonal). With Roche and its Genentech reached an exclusive license agreement for oral androgen receptors (AR) degradants (AR) degradants (AR) degradants (AR) degradants (AR) degradation agents, gene Tike will pay Shanghai Jiyu to $ 60 million down payment, milestone monument The highest amount can reach up to $ 590 million; Astrikon has obtained HBM7022's global exclusive rights and interests, and Platinum Medicine will receive $ 25 million in advance and up to $ 325 million milestones. Fees and wait.

As more and more large -scale license transactions are reached, it shows that the innovation capabilities and products of Chinese pharmaceutical companies are being recognized globally. At the same time, in the situation of frequent frustration of independent overseas, this model of "ship" to the sea may become the "main channel" for local innovative pharmaceutical companies to enter the global market.

How to choose the three modes of "going to sea"?

According to KPMG's "Chinese Pharmaceutical Companies to the White Paper", there are currently three main models in innovative pharmaceutical companies: First, to go to sea independently. That is, Chinese pharmaceutical companies conduct clinical trials overseas with their own strength, and then declare their listing. They are sold after approval. The advantage of this model is that it is not easy to be led by nose, which is conducive to consolidating the foundation of corporate global layout. At the same time, there are also certain challenges, if there is a multinational project coordinating and vision of compound talents; communication with local government departments; strategic vision of management; corporate financial resources and other challenges.

The second is to go to the sea by "boat". Including License Out, patent authorization, Chinese pharmaceutical companies sell their products' overseas/global rights and interests to overseas companies. Overseas companies are responsible for subsequent clinical development, declaration, production and sales. This is also the most "going to sea" by Chinese companies. The advantage of this model is that it is flexible and efficient, and it is relatively high to the corporate threshold. The challenge is the choice of partners and whether they can achieve the best results in negotiations.

Third, join forces to go to sea. That is, the joint development of Chinese pharmaceutical companies and overseas pharmaceutical companies, sharing costs and income, is a form of discounts; or equity authorization, sales channel cooperation, etc., mainly to find acquisitions and mergers by finding more mature local companies. The advantage is that there is a good way to eliminate local policy barriers, but there are certain invisible challenges in cross -cultural communication management.

Faced with these three mainstream methods of going out to sea, especially when innovative pharmaceutical companies are frequent frustrations, how to win the battle to the sea has also become a focus on many people in the industry.

In an interview with the 21st Century Business Herald, a chief analyst of the pharmaceutical industry in a securities institution pointed out that the global layout needs to make a reasonable layout from three aspects: product, target market, and enterprise. The clinical development of products should ensure the clinical needs of the potential target market and avoid homogeneous competition. Product research and development and clinical data should effectively meet the requirements of the target market supervision, especially the potential changes in future regulatory requirements. The overall market potential, clinical demand, clinical development, registration, access, and commercialized environment of different target markets are evaluated. You need to choose soils that are suitable for products to thrive. The endowment of the enterprise itself is also an important consideration of the global layout. Whether it has sufficient overseas market insights, whether it can establish relevant capabilities in the local market, and whether the resources can meet the requirements, etc., have determined that products can be met in different overseas markets. The possibility of layout and the potential entry model.

"Borrowing a boat to go to the sea is the most adopted model, and it is also the most easy -to -control mode to go out to the sea." The analyst said that the pharmaceutical company goes out to the sea and selects the appropriate partner through full and in -depth due diligence.

In fact, from the data point of view, tumors are now the key areas of corporate License Out. According to the Pharmaceutical Rubik's Cube, 80%of the projects in more than 20 transactions in the first half of this year belong to the tumor field, and only 20%of the projects in other fields. The rare disease projects reached by the biology and TR-Pharm (oral transformation ALDH2 activator), as well as a new type of small molecular projects for the treatment of metabolic diseases reached by Li Lili and Hutchida.

How to control the time of License Out?

The License Out model is usually the company's early research and development of drugs, and then authorizes the project to other pharmaceutical companies to do later clinical research and development and listing. According to the milestone model, it has obtained clinical results in various stages and a certain percentage of sales after commercialization. This also means that most of the License OUT projects will aim at the early stages of products, and the market risks behind the early days need to be considered urgently. After all, for the early stages (pre -clinical project) companies, this stage is called the "golden period" of local pharmaceutical companies' "going to sea". Do a good job of investigating and preparing for other aspects. In the face of some challenges and accidents, you should adjust the strategy at multiple levels to stop loss at the same time.

In addition, in the early stage, enterprises must have a full understanding of the local market access and competitive environment (such as patient quantity, access difficulty, competition pattern, price space, etc.), thereby evaluating the commercial potential and of the commercial potential and Difficulty. In addition, we must also think about the layout of clinical development with the idea of ​​"ending as the end", and have a clear understanding of the types of clinical trials of target countries. For example, how to develop the important target product introduction (TPP) development? How to continuously and effectively collect regulatory intelligence of target countries? How to carry out different international cooperation? What is the specific requirements of CMC (that is, the research of regional IVB stability)? How to check the mutual recognition protocol (GMP certification)?

Shen Xiaohua, vice president of Jimin Credit Group and head of the Strategic Market Medical Center, pointed out in an interview with the 21st Century Business Herald that the company will choose to actively seek third -party cooperation in the early days of innovation. After commercial cooperation, it is not "one -size -fits -all" with the product, and there will still be a certain percentage of commercial interests. In this way, the company's subsequent independent research and development projects through License Out's return funds. In the subsequent clinical stage of product project selection, the experience of communicating with partners in the License OUT project is also required to further conduct the company's product pipeline standard layout and adjustment, and to carry out a strategic layout.

This is also one of the important features of License Out. Through cooperation with overseas pharmaceutical companies, local pharmaceutical companies can not only achieve complementary advantages on the R & D side, reduce the risk of new drug research and development, but also use the sales network of international pharmaceutical companies on the sales side to make domestic innovative drugs enter the international market faster into the international market. And get rich cash flow returns.

"Regardless of the License Out or the layout of the independent R & D pipeline, it is a process of crossing the river with stones. The choice of local companies to cooperate with multinational enterprises also see the commercialization capabilities of multinational pharmaceutical companies. When looking for a global partner, the characteristics of Biotech and Big Pharma must be fused to inclusive differences. "Shen Xiaohua said.

According to the 21st Century Economic Herald reporter, in addition to the non -opioid analgesic project reached with Orion, according to the recent trading agreement with Roche, Roche will obtain JMKX002992's exclusive development and commercialization rights in the world. And bear all development and commercial costs. To this end, Genick will pay Shanghai Jiyu's US $ 60 million down payment and pay the corresponding development and commercial milestones when reaching a milestone agreed in the agreement. The milestone will be up to $ 590 million. In addition, Shanghai Jiyu will also obtain a gradient commission based on net sales -based sales.

Cui Haifeng, vice president and chief science officer of Jimin Citizen Group, told reporters from the 21st Century Business Herald that a total of three LINCESE OUT projects were completed from the end of November last year to August this year. Both risks will be considered. "For the companies of both parties, there are risk points behind License Out, which requires a comprehensive evaluation based on preclinical data. It is not a picky partner, which is also based on the consideration of industry standards. The License Out is also based on partners' judgment and strategic layout of business value, forward -looking judgment and strategic layout. This is also because there are many considerations behind the selected projects in today's era, and it is even more difficult to take the path of innovation and globalization. The reality of being difficult. But even if it is difficult, the road to globalization is an inevitable trend. "Cui Haifeng said.

How to break through the "going to sea"?

Some people say that in the context of fierce competition in the domestic innovative drug market, it is difficult to survive alone. Especially in the context of the increasingly fierce competition in the industry and homogeneous competition, even if the "one brother" Hengrui Pharmaceutical, which was independently developed in the past, began to enter the License in/OUT. However, License Out is not smooth sailing. Earlier, there were cases of License Out failed by star BIOTECH companies. So, what is the License Out approach is the key to victory?

In response, Zhao comfortable analysis of the person in charge of the investment consulting department of iQVIA Aikunwei Management Consultation Department pointed out that when considering external cooperation, emerging biopharmaceutical companies need to find suitable business partners in stages and regions. By cooperation with emerging biopharmaceutical companies, large pharmaceutical companies can enhance their innovation capabilities, expand their business scope, and enter new business areas. At the same time, emerging biopharmaceutical companies can accelerate the later commercialization process in cooperation with large pharmaceutical companies. Some Asia -Pacific regions are not mature, intellectual property protection is relatively weak, the market conditions are complicated, and emerging biopharmaceutical companies often have limited understanding of the local market conditions, so it is necessary to find a good local partner in these areas. In addition, in markets such as Japan and China, the familiarity of local sales channels and the channel network of hospitals have a great impact on product penetration. Therefore, they need to pay attention to this when choosing partners. A major feature of the Asia -Pacific region is that market demand and policy tendencies in different regions are often very different. Therefore, the formulation of business strategies and cooperation strategies must be adapted to local conditions.

The combination of corporate products considers the market environment and resource conditions, and moderately increases the new products and eliminate recession products, thereby maintaining the dynamic balance of corporate income, that is, the company's product portfolio that can always maintain maximum profits. Zhao Xie introduced that when considering the product portfolio strategy, there are the following main considerations: First, the company's existing pipeline products can provide growth drive within a certain time window, but the growth will not continue to continue, and it cannot be maintained all the time. The company's internal growth demand; second, different enterprises have different internal yield and growth rate goals, and need to cooperate with specific goals and income requirements to reasonably formulate product portfolio strategies; third, enterprises should match the life cycle of pipeline products to consider how to pass through the life cycle of pipeline products. Develop new products or acquire new products to make up for the growth gap of existing product portfolios to achieve the long -term strategic goals of the enterprise.

"How to judge that an innovative pharmaceutical company has a strong commercial competitiveness in the Asia -Pacific region. It is traceable. Whether a pipeline product can succeed in License OUT, in fact, it can be determined when the project is formed, so the choice of targets and indications for indications and indications It is very important. For emerging biopharmaceutical companies, it is particularly critical to find a suitable business partner. The stronger the partner's strength, the better the core value of innovative drugs. At the same time, emerging biopharmaceutical companies should Formulate a practical product portfolio management strategy, and consider the choice of product and resources matching, so as to support the sustainable development of the enterprise. "Zhao Xun said.

As for whether the License Out will become the success of the success of "going to the sea", Yu Zilong, the partner of the KPMG China Life Science Industry, emphasized in an interview with the 21st Century Business Herald that pharmaceutical companies will face four aspects of challenges: First, products Whether there is a competitive advantage; second, whether the strategy of going to sea is appropriate, such as where to go, how to go; third, whether to understand the relevant local policies; fourth, whether to have a professional overseas team and talent.

"No matter what pattern 'go to sea', it will face many pressures such as capital, speed, environment, talent, etc." Yu Zilong said that finding rules from refusal cases, "going to sea" means entering the world barrier. Product competition must not be the same as domestic on the same day, and it needs absolute advantages. Drug test data is strictly certified and approved by authoritative institutions such as FDA, which is a prerequisite for the company's "going to the sea". In addition, the clinical data of drugs, that is, effectiveness, safety, or not absolute advantages compared with existing drugs, are an important assessment point for FDA to approval. Therefore, trying to enter the US market with a "price advantage" method of "price advantage" may not have a lot of money. This is due to the US drug price system and drug clinical data, which is actually two independent management systems.

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