China's new drug licensing cooperation culminates in commercialization as a key factor in the license-in negotiations.

"In today's BD cooperation, the partners are no longer only looking at research and development capabilities, but the comprehensive capabilities of enterprises from research and development, production to sales.
"When I returned to China ten years ago, I first joined Hengrui Pharmaceuticals, and they didn't have a BD department.
are at a very early stage, both in terms of quantity and quality of BD.
but now, ten years later, China is on international standards.
" Liu Ming, senior vice president of global business development at Corning Jerry's, was impressed.
many industry insiders lamented that looking back on the last decade, the current China's new drug licensing cooperation is not what it used to be.
in recent years, there have been more and more cases of cooperation between local pharmaceutical companies and foreign pharmaceutical companies in new drugs. Between 2010 and 2019, there were 596 large-scale mergers and acquisitions worldwide, with $1.6 trillion in transactions, according to
Informa.
"This decade is actually the golden age of BD.
," said Zhang Yue, chief consultant of the Informa Pharmaceutical Advisory Group.
experienced a decade of golden age, and in the first half of 2020, even as the new crown epidemic raged, china's new drug-licensing cooperation remained active.
since 2015, major clinical value new drugs into the priority review, drug listing licensor system, encourage enterprises at home and abroad to simultaneously develop new drugs and other policies have been promulgated, so that China's pharmaceutical industry innovation ushered in a period of rapid development.
with the diversification of innovative subjects, research and development model is no longer single.
in addition to self-development, many pharmaceutical companies have also chosen to cooperate in development, project purchase and so on.
pushing new drugs to market as soon as possible may be the first step in the eyes of many pharmaceutical companies to succeed.
and cooperation with new drug projects has become the choice of these drug companies.
but under the health insurance negotiations, collection and other policies, a number of industry insiders said that the new drug cooperation in the model has not only introduced new drug research and development market, how to commercialize, how to sell, is gradually becoming a key factor in the cooperation can be reached.
the new crown-related drugs are the focus, tumors are still popular according to the incomplete statistics of euthanasia health, in the first half of 2020, the new drug field authorized trading cooperation reached at least 40.
, drugs associated with the new crown outbreak are among the focus.
in the new crown vaccine field, Fosun Pharma's $85 million vaccine program with BioNTech is the most notable.
Starting from January 29 this year, Fosun Pharma began contact with BioNTech, which took 2 days to complete the research and development plan and the design of the I-III clinical program.
contracted on March 13, Fosun Pharma took just six weeks to obtain bioNTech license to develop and commercial the new Crown vaccine products developed exclusively in China based on its proprietary mRNA technology platform.
, Fosun Pharma will pay BioNTech up to $85 million in licensing fees (including down payment, clinical development registration and sales milestones) and pay a sales commission of 35% of the product's annual gross profit during the agreed sales commission period.
, a $50 million equity investment in BioNTech.
,000, followed by Pfizer, the international drugmaker.
also reached a partnership with BioNTech on March 16 thin lying around the mRNA new crown vaccine, but the agreement does not include the Chinese market.
currently, Fosun Pharma's mRNA vaccine (BNT162b1) has been launched in Phase I clinical trials in China.
in addition, a number of Chinese pharmaceutical companies have also reached cooperation in the development of new crown virus vaccines or antibodies.
, the virus vector new crown vaccine has entered the clinical phase of The coinnobio, and canada's Precision NanoSystems (PNI) has reached an agreement to develop a new coronavirus vaccine based on mRNA lipid nanoparticles (mRNA-LNP) using PNI's unique RNA vaccine technology platform, and Considine bioswill will be given the right to promote vaccine products in Asia (excluding Japan).
and platinum medicine, Junshi biology, etc. with different pharmaceutical companies have reached a new crown virus antibodies cooperation.
it's worth noting that the new Crown Virus Antibody partnership between Junshi Bio and Lilly belongs to license out, a type of licensed transaction cooperation that has grown in recent years.
2018 was once seen as the year of the big explosion.
but even if the out-of-the-box trend is catching up, the current domestic development of innovative drugs is still licensing (license in) in the mainstream.
According to the pharmaceutical Magic Cube statistics, from the authorized introduction of products, the introduction of innovative drug projects in the past 5 years mainly concentrated in the field of tumors, blood diseases, immune diseases, the total proportion of more than 50%. Trading activity in
specialty areas such as skin, respiratory and ophthalmology has increased.
this feature continues in the first half of 2020.
in addition to the field of cancer immunity drugs, just recently listed on the Hong Kong Stock Exchange of The introduction of two eye drugs in the first half of this year, China's great medicine and the introduction of one of the extreme biology.
the increasing trading activity in the field of specialty, the introduction of innovative pharmaceutical projects has become more abundant.
License in the continuous hot, commercialization capacity is the key current, large-scale multinational pharmaceutical companies research and development efficiency reduction facing the adjustment of product pipelines, small and medium-sized European and American pharmaceutical companies have sought to enter the Chinese market through cooperation with domestic enterprises, for domestic pharmaceutical companies to provide an opportunity for transaction cooperation. the essence of the
mainstream approach is the division of labor and cooperation, which means that different enterprises need to develop products at different stages and cooperate financially and technically.
therefore, when pharmaceutical companies focus on projects, they will also pay attention to whether the operating models and cultural differences of cooperative enterprises can be honed with each other.
Tianyi Bio CEO Shen Huaqiong still clearly remembers the experience of a BD, when the two sides negotiate, 90% of the content is not around the drug itself, but the enterprise's culture, mode of operation, team ability and so on.
, a company that focuses on innovative biopharmaceuticals in the field of tumor immunity and autoimmune diseases, has built a Chinese pipeline aimed at "fast product launches" to market through licensing the introduction of products.
these candidates have demonstrated good clinical safety and initial efficacy through Phase I or II clinical trials in the United States, Europe, or elsewhere.
and when the product enters the approval stage, how to push the product to market with the fastest speed and the shortest time, preempting the market is the next important factor to be considered when negotiating.
", "A few years ago, talking to partners about how you sell drugs, how big the Chinese market is, they are very concerned. "But not now, " said Wang Wei, senior vice president of business development at re-ding Pharmaceuticals,
.
China now accounts for 40 to 50 per cent of their market share, and they can set up their own subsidiaries in China.
" Therefore, for successful buyers, it is also important to understand the strategy of the market.
, said in its report that the success factors of the license in buyers include three points, one is abundant financial strength, the other is strong research and development capabilities, and the third is first-class sales capabilities.
commercialization of products is the key to the blood-making of enterprises, and the implementation of health insurance catalog negotiations, volume procurement and other policies, in the impact of the valuation of cooperative products, but also put forward higher requirements for the commercialization capacity of pharmaceutical companies. Jiang Hua, vice president of
Green Leaf Pharmaceuticals, said: "The introduction of a product will involve a very complicated approval issues, policy issues."
is whether the supply chain can be opened.
if the supply chain is not open, the national collection can not do not.
there is also to have a plan, once the front of a large investment, the new drug to push to market, but approved but found that there is no way to sell, that will be a problem.
" Reding Pharmaceuticals and Green Leaf Pharmaceuticals are the representative enterprises of license in, and then Ding Pharmaceuticalby by virtue of the introduction of products with large international factories by the industry, its basic business model is license in-CRO-VC.
, green leaf pharmaceuticals rely on its sales and promotion business capabilities to generate revenue through the continuous introduction of re-cooperative research and development, as well as acquisitions.
at the moment, China's pharmaceutical industry is in a period of change under the combination of volume procurement and health care catalog negotiations.
in the volume of procurement, the winning enterprises can get about 60%-70% of the market share.
But if the flow marks, the species' income will drop sharply.
in the second round of the collection, East China Pharmaceuticals had failed to win the bid for its Acapo sugar drug, the news of the stock price immediately collapsed, by midday close the share price has fallen 9.24%, the capital market reaction.
and before that, innovative drugs have been difficult to enter the health insurance catalog problem.
While the value of generic drugs is gradually returning to a reasonable range through collection, allowing it to spend more on health insurance to support new drugs, the market cake is limited each year and squeezing into the health-care catalog is still a big test for every drug company.
"In the current new drug licensing cooperation negotiations, the other side values how much voice you have in the Chinese market, what ability to register, how long the product can pass the approval, and compliance issues.
is also the ability to get into the health care catalog. jiang Hua,
, pointed out, "In the current BD cooperation, the partners are no longer only research and development capabilities, but the comprehensive capabilities of enterprises from research and development, production to sales."
"