"Innovation + going to sea" is not limited to Biotech

Affected by the news that the United States is ready to sign the executive decree to expand the US bio-manufacturing industry, the CXO concept stock in the A-share market fell

However, there is a saying that pessimists are always right, and optimists always succeed

Especially with the enhancement of the independent research and development strength of local pharmaceutical companies, more and more projects have been recognized by

"Innovation + going to sea" is not limited to Biotech

Pharmaceutical Cube Nextpharma shows that in 2022, there will be nearly 40 domestic license out projects, with a total transaction amount of more than 10 billion US dollars and a total down payment of 720 million US dollars

Divided by project type, including 24 innovative drug/new technology transaction projects, accounting for 68.

Source: Nextpharma

From the perspective of the enterprises affiliated to the license out project, there are both traditional old pharmaceutical companies such as CSPC, Green Leaf and Jimin Trust, as well as start-up biotech from Lixin Pharmaceutical, Tianyan Pharmaceutical, and Duoxi Biology; At the same time, there are also biopsharma

In 2022, there are more than 2 enterprises going to sea license out projects

Source: Nextpharma

Both cross-border BD and CRO organizations are working to facilitate the overseas trading of Chinese innovation projects

When it comes to the sources of the selected targets/projects, the innovative labels of biopharma, biotech and traditional pharmas seem to be increasingly blurred

Just as Jimin Credible, who started with traditional Chinese medicine, reached 3 "going to sea" transactions in 9 months, which shocked many peers who have continued

Strategic level: capital + talent

Colleagues who have been deeply cultivated in the pharmaceutical industry for a long time can see at a glance that the transformation of Traditional Chinese medicine enterprises represented by Jimin Credible to do innovative drugs is basically consistent

Compared with biotech relying on financing to make innovative drugs, traditional pharma relies on self-bloodletting, and its goal is either transformation and upgrading, or strengthening the innovation gene, or it may be to seek new market increments to optimize the product structure

Taking Jimin Credible as an example, the company has laid out innovative drugs from 2018 and proposed a strategic plan of "8 years to invest 10 billion yuan", and has now established three innovative preclinical research institutes of large molecules, small molecules and innovative technologies

When asked what exactly they did right before planning BD's voyage to sea? The company's management agreed that the primary reason is the support of the strategic level of the enterprise, especially the persistent investment in research and development, so that it can hire excellent R&D personnel in the team recruitment from the beginning according to the market higher than the "above 70-bit quantile" level, and build a good talent system and R&D system

Implementation level: project establishment + data

There is a highly credible saying in the pharmaceutical industry called data tells all

Successful BD begins with project establishment, and project establishment should not follow the trend

In the specific practice process, the second step is to gain insight into the regulatory trends and epidemiological trends oriented to clinical needs in advance, and identify the corresponding project establishment strategies

Following PD-1 and CAR-T, the world has set off a boom
in research on PROTAC drugs.
Domestic PORTAC drug research and development is also in full swing, the pharmaceutical cube Nextpharma shows that there have been more than 200 PROTAC projects in the world to disclose progress, there are more than ten PROTAC for AR targets, why did Genentech abandon some projects that have entered the clinical stage, and instead choose the JMKX002992 project that has not yet entered the clinical stage and has very little public data disclosure?

Source: Nextpharma

Dr.
Peng Jianbiao, President of the Small Molecule Innovation Research Institute of Jimin Trust Group, explained to Medera that 2992 is a new oral AR degrader that has therapeutic potential for prostate cancer patients resistant to existing therapies and complements
Roche's work in the development of innovative treatment options for advanced prostate cancer.

According to people familiar with the matter, the 2992 project screened nearly 800 molecules at that time, and at most invested a total of more than 30 chemical fte (compound research and development full-time service).

Before a deal is struck, the "buyer" typically compares multiple candidates, some even take the candidate compounds for early "head-to-head" studies, and then select the most satisfactory ones
.

One of the most critical factors in the final conclusion of the transaction is whether the relevant data obtained by the "buyer" is solid
.

Dr.
Cui Haifeng, vice president and chief scientific officer of the company, said that in the era of increasingly "internal volume" of innovative drugs, there are many considerations behind the buyer's choice of good projects
.
From the seller's point of view, it is even more difficult to take the path of innovation and globalization
.
But no matter how difficult it is, taking the road of globalization is an inevitable trend
.

Transaction level: pay attention to soft factors

Since you have a research and development budget of 10 billion yuan, why choose to sell 2992 global rights and interests in the way of "selling young seedlings"? Shen Xiaohua, vice president of Jimin Credible Group and head of the Strategic Market Medical Center, responded to this, on the one hand, the company's subsequent independent research and development projects can be fed back through the return funds of license out; On the other hand, the experience gained from communicating with partners can quickly improve the layout
of international product pipelines.

Yu Ying, vice president of the company and head of the business investment center, added that the high demand of partners is a positive factor, because it is based on the consideration of industry standards, but also indirectly helps to improve its comprehensive strength
.
In the long run, the two companies have reached a cooperation, how to play the effect of 1+1>2, so that each other win-win, common growth is the most critical
.

Reviewing a number of BDs reached in the past, the other party admitted that there are risk points
behind any transaction.
How to conduct a comprehensive assessment based on preclinical data not only tests the eyesight of the "buyer", but also tests the endurance
of the "seller".
As a seller, the first thing is to have a correct mindset; Second, empathy; The third is to pay attention to the level of project management, and to plan in advance and dynamically adjust
every step of the development process.

epilogue

The word "going to sea" seems very simple, but in fact, it is not only a road to product innovation and development and the expansion of the follow-up listing path, but also a manifestation
of the ability of pharmaceutical companies to integrate resources.
Especially for some projects that are still in the PCC stage, how to choose the right partner and clinical trial protocol (trial design, clinical trial center, indication selection) to improve the probability of success of conceptual clinical trials, how to deal with different regulatory agencies, and even improve the efficiency of patient enrollment, etc.
, may require the details of both BD parties
to plan ahead.

For pharmaceutical companies, what tracks and targets to lay out, what varieties to choose, who to cooperate with, how to set the cooperation framework, and how to achieve better expectations are all important parts of
BD's strategy.
"Innovation + going to sea" will not only be Biotech, but an important puzzle
for the overall strength of all pharmaceutical companies.
Each company's BD strategy is based on its actual situation and its own strategic considerations, and the success of others can only be learned from, not copied
.