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

Lin Yiling Editor: Liu Cong ,"In the current BD cooperation, the partners are no longer just research and development capabilities, but the comprehensive capabilities of enterprises from research and development, production to sales."
" when I returned home ten years ago, I first joined Hengrui Pharmaceuticals, and they wouldn't have a BD department.
is in a very early stage, both in terms of quantity and quality of BD.
but ten years later, China is in line with the international standards.
, senior vice president of global business development at Corning Jerry's, is deeply touched.
industry, many industry insiders lamented that in the last decade, the current China's new drug licensing cooperation is not what it used to be.
recent years, there have been more and more cases of cooperation between local pharmaceutical companies and foreign pharmaceutical companies in new drugs.
2010-2019, there were 596 large-scale mergers and acquisitions worth $1.6 trillion, according to Informa, a global research group.
decade was actually the golden age of BD.
," said Yue Zhang, chief consultant at Informa Pharmaceutical Consulting Group.
a golden decade, and in the first half of 2020, even as the new crown epidemic raged, China's licensing of new drugs continued to be active.
Since 2015, major clinical value new drugs have been incorporated into the priority review, drug listing licensing system, and policies to encourage enterprises to simultaneously develop new drugs at home and another, which has ushered in a period of rapid development of innovation in China's pharmaceutical industry.
with the diversification of innovation subjects, the 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 success of many pharmaceutical companies.
new drug program, it has become the choice of these pharmaceutical companies.
But under the implementation of 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 on the market, how to commercialize, how to sell, is gradually becoming a key factor in whether cooperation can be achieved.
new crown-related drugs are the focus, tumors are still popular according to the incomplete statistics of E.O. Health, in the first half of 2020, the field of new drugs authorized transaction cooperation reached at least 40.
, drugs associated with the new crown outbreak are one of the focal points.
in the new crown vaccine field, Fosun Pharma's $85 million WinnTech vaccine program is the most notable.
january 29 this year, Fosun Pharma began to contact BioNTech, which took two days to complete the research and development program and I.-III clinical program design.
, which was signed on March 13, took just six weeks to obtain BioNTech's license to exclusively develop and commercialize new crown vaccine products in China based on its proprietary mRNA technology platform.
In accordance with the agreement, Fosun Pharma will pay BioNTech up to $85 million in licensing fees (including down payments, clinical development registrations and sales milestones) and a sales increase of 35% of the product's annual gross margin during the agreed sales increase period.
also invested about $50 million in BioNTech.
,000 soldiers, followed by Pfizer, the world's largest drug company.
also teamed up with BioNTech on March 16th for a new mRNA crown vaccine, but the agreement does not include the Chinese market.
, Fosun Pharma's MRNA vaccine (BNT162b1) has been launched in Phase I clinical trials in China.
addition to this, a number of Chinese pharmaceutical companies have also reached cooperation in the development of new crown virus vaccines or antibodies.
In this regard, the virus vector new crown vaccine has entered clinical phase II. Conschino Bio, also reached an agreement with Canada's Precision NanoSystems (PNI) to use PNI's unique RNA vaccine technology platform to develop a new crown virus vaccine based on mRNA lipid nanoparticles (mRNA-LNP) technology, and Consino Bio will be given the right to promote vaccine products in Asia (excluding Japan).
and platinum medicine, Junshi Biological, etc. have reached cooperation with different pharmaceutical companies on the new coronary virus antibody.
noteworthy that the new crown virus antibody collaboration between Regency Bio and Lilly belongs to the license out, and this type of licensing transaction cooperation has been increasing in recent years.
2018 is thought to be the year of the outbreak.
but even if there is a catch-up trend, the current domestic development of innovative drugs is still licensing (license in) occupies the mainstream.
according to medical Rubik's Cube statistics, from the authorized introduction of products, the introduction of innovative drug projects in the past five years mainly concentrated in the field of cancer, blood diseases, immune diseases, the total proportion of more than 50%.
activity increased in specialist areas such as skin, respiratory and ophthalmology.
feature continues in the first half of 2020.
In addition to drugs in the field of tumor immunity, OconviV, which has just been listed on the Hong Kong Stock Exchange, introduced two ophthalmology drugs in the first half of this year, while China's Great Pharmaceuticals and Polar Biology each introduced one.
increasing trading activity in the field of specialty, the level of introduction of innovative drug projects has become richer.
License in continued hot, commercialization capacity is the key at present, large multinational pharmaceutical companies research and development efficiency reduction face product pipeline adjustment, small and medium-sized European and American pharmaceutical companies have been through cooperation with domestic enterprises to seek access to the Chinese market, for domestic pharmaceutical companies to provide an opportunity for trading cooperation.
the essence of the mainstream approach is division of labor and cooperation, which means that different enterprises need to develop products at different stages and work together financially and technically.
therefore, when pharmaceutical companies focus on projects, they will also pay attention to whether the mode of operation and cultural differences of cooperative enterprises can be interted with each other.
Tiantian Bio CEO Shen Huaqiong still clearly remembers a BD experience, when the two sides negotiate, 90% of the content is not around the drug itself, but the culture of the enterprise, operating mode, team ability and so on.
Tiantian Bio is a company focused on innovative biopharmaceuticals in the field of tumor immunity and autoimmune diseases, which, by authorizing the introduction of products, has built a Chinese pipeline aimed at bringing "rapid products to market".
these drug candidates have been tested in phase I. or II clinical trials in the United States, Europe, or elsewhere, demonstrating good clinical safety and initial efficacy.
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 and how big the Chinese market is, they're very concerned.
, senior vice president of business development at Reding Pharmaceuticals, said, "But not now."
, which now accounts for 40 to 50 per cent of their overall market share, is well placed to set up its own subsidiary in China.
", for successful buyers, they must also understand the strategy of the market.
said in its report that the success factors of 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 blood production, and the implementation of policies such as health insurance catalog negotiation and volume procurement, which affect the valuation of cooperative products, also puts forward higher requirements for the commercialization capacity of pharmaceutical companies.
, vice president of Green Leaf Pharmaceuticals, said: "The introduction of a product will involve a lot of 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 it.
there is still to have a plan, once the previous investment is very large, the new drug to promote the market, but the approval found that there is no way to sell, that will be a problem.
" Reding Pharmaceuticals and Green Leaf Pharmaceuticals are representative enterprises, Reding Pharmaceuticals by virtue of the introduction of products with large international factories by the industry recognized, its basic business model is license in and CRO-VC.
and Green Leaf Pharmaceuticals relies on its sales and promotion capabilities to generating revenue through the continuous introduction of re-cooperative research and development, as well as acquisitions.
, China's pharmaceutical industry is in a period of transformation under the combination of volume procurement and health care catalog negotiations.
in the volume procurement, the winning enterprise can get about 60%-70% of the market share.
but if the flow marker, the variety's income will drop sharply.
In the second round of the collection, East China Pharmaceuticals, which had failed to win the bid for its akapo sugar drug, flashed its share price when the news broke, and by midday it had fallen 9.24 per cent, a sign of the reaction of the capital markets.
, innovative drugs have had a difficult time getting into the health-care catalog.
While the value of generic drugs is gradually returning to a reasonable range by collecting them, allowing them to out more health-care spending to support new drugs, the market cake is limited every year, and squeezing into the health-care list is still a big test for every drugmaker

"In the on-the-go negotiations on new drug licensing cooperation, the other side is very important to how much you have a say in the Chinese market, what ability you have in terms of registration, how long the product can pass the approval, and compliance issues.
is what capacity is available for access to the health insurance directory.
" Jiang Hua pointed out, "In the current BD cooperation, the partners in essence is no longer just research and development capabilities, but enterprises from research and development, production to sales of comprehensive capabilities."
"