On January 4, the PD-1 field received two blockbuster news.
One is that Junshi Bio announced the termination of the sales cooperation with AstraZeneca on PD-1, and the two sides held hands for just 10 months to catch up with the AstraZeneca sales pattern adjustment, and the county team was merged, and there was no time to take care of partners.
Junshi Bio's Triplelizumab is the first domestic PD-1 listed, but it has not been able to build a first-mover advantage, and it has not been able to stir up waves by the hands of AstraZeneca, which has to be said to be an industry regret.
But PD-1's successors are still in the footsteps. Also on January 4, 3SBio announced that its subsidiary, Sunshine Guojian, had licensed PD-1 product 609A to Syncromune in the United States for the global interest in the combination therapy of tumor immunotherapy syncrovax.
Under the agreement, 3SBIS will receive benefits such as down payments, milestone payments, and other incentives, totaling hundreds of millions of dollars. This is the first overseas authorization of China's domestic PD-1 in the context of the new drug industry being looked down upon in 2022.
China's PD-1 market is like a besieged city, people outside the circle squeeze their heads and want to come in, and people in the circle want to go out for better survival. The opportunity still exists, and in this competition that marks the pattern of China's innovative drug market, no one is willing to concede defeat first.
The New Year is off to a great start
Since the beginning of 2021, important changes have taken place in the biomedical industry.
The participation of medicare has greatly disrupted the PD-1 market, which was originally defending its territory. At present, all the domestic PD-1s that meet the conditions have entered the medical insurance, and none of the imported varieties have entered the medical insurance. The varieties of Corning Jerry and Kangfang Bio, which failed to catch up with the 2021 medical insurance negotiations, gave a large discount on the price and competed for users as much as possible.
It is foreseeable that the domestic PD-1 that has been listed in 2022 will enter the medical insurance, and the price war between each family will become more and more fierce.
Is there any hope for the PD-1? This question was asked from 2017 to 2022.
Overseas is considered to be the best export of China's PD-1, after all, there is no serious bargaining in mainstream markets such as Europe and the United States. Companies see overseas promotion and License-out as important spaces for PD-1 growth in the future.
However, not every PD-1 can find overseas buyers. The product pattern in the international market is solidified, K drugs and O drugs occupy the mainstream, and other brands themselves are not easy to survive. Going overseas, it is not only the price, but also the quality of the product.
China's PD-1 field is facing double pressure: domestic needs low prices, foreign countries need to ensure high quality, forcing enterprises to invest in research and development and cost control to take a two-pronged approach.
This is why many innovative pharmaceutical companies are stretched thin to develop the PD-1. The development of PD-1 involves a lot of resource investment, I am afraid that there will be enterprises that will be unsustainable, so there is a saying in the industry that "competition in 2022 is known".
There are nearly 100 PD-1 varieties in the domestic market, why can 609A become the first to go to sea in 2022?
According to the statistics of the Health Bureau, the domestic PD-1 can be queried to carry out clinical practice in the United States no more than 4 varieties, 609A is one of the few Sino-US clinical double-reported varieties, Phase I clinical completion in the United States, which is the premise of overseas recognition and cooperation.
The person in charge of research and development of 609A told the Health Knowledge Bureau that the products developed later have the advantage of being a latecomer and can be compared with the PD-1 that has been listed in China, "Preclinical studies have shown that drug activity, animal pharmacokinetics, pharmacodynamics, etc. have reached or exceeded similar varieties." At present, 609A is carrying out clinical trials in China and the United States, mainly for breast cancer, liver cancer, etc., and is also developing some small cancer species.
In addition to product quality, another key is cost.
As a veteran domestic biopharmaceutical company, Sunshine Guojian has the earliest large-scale monoclonal antibody production line built in China. The Health Bureau has learned that the company's 40,000L certified commercial capacity is still one of the largest capacities in use in China.
In terms of pipeline layout, the existing varieties of Sunshine Guojian are all antibody drugs, which can ensure the maximum use of its own production capacity and ensure the supply of drugs.
A new model of cooperation that achieves mutual success
In this transaction, the authorization of 609A only involves the global interest of syncrovax in the combination therapy of tumor immunization, that is, the joint use of tumor treatment with US equipment. Therefore, the overall licensing fee of the transaction is not much compared with the overseas BD of beiGene, Junshi, Cinda and other pharmaceutical companies.
This is the first step in the "going out" of the company's PD-1 product, and the company retains a global interest in 609A outside of any syncrovax therapies.
The Health Bureau has learned that Syncromune's main business is the development of innovative therapies in the field of oncology, and the cooperation with Sunshine National Health will bring long-term help to it. The innovative therapy, Syncrovax itself, is in the research and development stage, and the selection of reliable PD-1 products in the pharmaceutical component is crucial to its successful development.
Clinical quality, affordable and stable supply of PD-1 are Syncromune's appeal to pharmaceutical partners. Therefore, combining these needs, 609A is the best choice.
In China's biopharmaceutical industry, it is difficult to find more senior players. In 2002, China's earliest monoclonal antibody production line was born in sansheng Guojian's predecessor, CITIC Guojian. Listed in 2005, "Yesep" is the first monoclonal antibody drug in the field of rheumatism treatment in China.
The company has more than 16 years of experience in monoclonal antibody production – what this means for the young Chinese biopharmaceutical industry is a natural way to understand.
Such production capacity can provide significant cost advantages and supply stability guarantee in overseas licensing cooperation.
The Health Bureau learned from within Sansheng Guojian that this overseas authorization is an important attempt for the company to go to a higher level of internationalization, in addition to bringing additional cash flow and income to the company, there is an overseas licensing foundation and an international development background, which is a more important goal. The cooperation between the two sides provides a strong endorsement of the future seaward path of the 609A and other products.
At present, 609A has carried out a number of Phase II clinical studies in China, and domestic clinical studies will further promote overseas clinical progress.
International strategies have been practiced for a long time
In fact, it is not the first time that 3SBio Group's products have been licensed overseas.
The case of 3SBI Health's parent company, 3SBI Pharmaceuticals license-out, dates back to 2014, when the gout drug Pecciticase (polyethylene glycolated recombinant Candida uridase) was licensed to Selecta for the development of gout combination therapy SEL-212. Currently, SEL-212 is used in the U.S. Phase III clinical trial for chronic refractory gout, and 3SBio also received a milestone payment of $4 million in 2019.
Under the consciousness of global BD, 3SBio and 3SBIS Guojian have not stopped the rhythm of license-in. In 2017, 3SBio introduced Toray Corporation's worldwide exclusive naforapin hydrochloride oral collapse tablets Remitch to the Chinese market, the only oral drug approved in the world for dialysis itching. At present, Remitch has been successful in the domestic Phase III bridging clinical trial, and has submitted a listing declaration and accepted.
Sunshine Guojian's overseas strategy is more focused on the cooperation of large molecules. In December 2019, Sunshine Guojian announced that it has cooperated with Verseau in the United States and has selected two monoclonal antibodies with PSGL-1 and VSIG-4 targets to introduce into China. In the same period, Sunshine Guojian negotiated with the Swiss company Numab and was allowed to introduce 5 antibodies.
Just when the market was looking forward to when Sunshine Guojian would achieve product output, the company won hundreds of millions of dollars with a PD-1, which surprised the market.
Relevant people familiar with pharmaceutical BD said that under the current fierce competition pattern, the PD-1 in the Phase I clinical stage in the United States can still be sold at this price, "the technology should not be ordinary."
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