Four domestic PD-1 all out to sea Hengrui, Junshi, Baiji, Xinda who overseas strength is the strongest?

01 Ripley single anti-sea finally, the last local PD-1 also announced the sea route! On February 1st Regeneron announced that it had entered into a partnership with Coherus BioSciences on the development and commercialization of its self-developed anti-PD-1 monoantigen Terripri monoantigen injections in the United States and Canada.
Under the terms of the agreement, Regeneron will grant Permission to Coherus Triculi monoanti and two optional items, such as execution, and receive down payments totalling up to $1.11 billion, optional project execution fees and milestone payments.
will work with Coherus to develop the Ripley monolith, which is responsible for all commercial activities in the United States and Canada.
's two options are mainly the right to choose or prioritize the four new cancer drugs owned by Regent Bio, including the options of JS006 (anti-TIGIT monoantigen) and JS018-1 (next-generation modified IL-2 cytokine drugs), as well as the priority negotiation rights of two unreclosed early stage checkpoint inhibitor antibody drugs.
will receive a down payment of $150 million under the terms of the specific cooperation.
For the Ripley monolith project, resuscant will receive a cumulative milestone of no more than $380 million, plus a 20% sales share of the net annual sales of Terripley monoliths in the licensed area, upon the corresponding milestone event.
for the JS006 and JS018-1 projects, Regency Will receive $35 million per project implementation fee.
the corresponding milestone event, Regency Will receive a cumulative milestone of no more than $255 million per project, plus an 18% share of the net annual sales of optional items in the licensed area.
will work together to develop Ripley monoanti and other licensed drugs, and Coherus will pay up to $25 million a year for co-development of each licensed drug.
, chief executive of Regeneron Bio, said, "Ripley Monoanti is expected to be the first domestically commercialized domestic anti-PD-1 monoantigen in overseas markets.
cooperation with Coherus will be an important part of Reus Bio's expansion of its global commercial network.
look forward to working closely with Coherus to establish Theprint's market position in the United States and Canada.
, a leading biosynthic drug company founded in 2010 in the heart of California's Silicon Valley, according to Its website.
its product pipeline has a number of biosynthic drugs, such as Pfeisting, Beval pearl mono-resistance (licensed from Cynda Bio in January 2020), Adamo mono-resistance, Inasip, Reju mono-resistance, Abersip, etc.
that more than 2,100 patients have been treated with Ripley monoantigen in clinical trials.
,000-year-old Priebus was included in the health-care list in the 2020 health-care negotiations for treatment of non-excisive or metastasis melanomas that have failed to receive systemic treatment in the past.
Junshi Bio expects more data from major studies to be released in the next three years, with 15 ongoing or completed critical registered clinical trials, including the International Multi-Center Study, assessing the effectiveness of different treatment options in a variety of solid tumors, covering lung, nasopharyngeal, esophageal, stomach, bladder, breast, liver, kidney and skin cancers.
02 four domestic PD-1 overseas strength? It is worth noting that this deal on the Ripley single-resistance means that the domestic PD-1 "Four Little Dragons" are all out to sea.
so what is the clinical progress of these four out-of-sea PD-1s abroad? Prior to License out, Junshi was also pursuing a strategy of double reporting between China and the United States for the Terriple single resistance.
Currently in the U.S., Ripley's single-drug treatment for nasopharyngeal cancer has been recognized by the FDA as a breakthrough therapy, and the FDA is expected to submit the fda's first biological product licensing application (BLA) for the certificate this year.
addition, the FDA awarded Ripley one fast-track qualification (mucosal melanoma) and three orphan drug qualifications (mucosal melanoma, nasopharyngeal cancer, soft tissue sarcoma).
over the next two years, Regency Bio and Coherus plan to submit more New Adaptation Certificates for Ripley monoantigens to the FDA for the treatment of a variety of rare and high-risk cancers, including non-small cell lung cancer.
January, Baiji Shenzhou sold its PD-1 product to Novaral for Reilly Pearl for a total of $2.2 billion.
This is the second time that Baiji Shenzhou has withdrawn its overseas interests in Reilly Pearl, and in 2017 the company gave its PD-1 entity development interest in Asia (excluding Japan) a $1.393 billion transaction price for Xinji, which was later acquired and reclaimed as Reilly Pearl Single Resistance until the transaction took place.
, however, that although Baiji has always had the will of License out, the clinical strategy for the single resistance of Reilly Zhu has been carried out simultaneously with the Sino-American double report.
According to Baiji's research and development pipeline, there are currently 6 different adaptation certificates for Reilly-Zhu single resistance in the United States for the third phase of key clinical, including 2-line non-small cell lung cancer, 1-line hepatocellular carcinoma, 1-line stomach cancer, 1-line esophageal squamous cell carcinoma, and three trials in the field of solid tumors, blood tumors have entered clinical phase 1b.
partners in the Xinda PD-1 sea-going strategy have been Lilly, so from the very beginning of the clinical trials of Xindelli monoantigen in the United States, Lilly is responsible.
According to Lilly's official website, Lilly has been on the Cynda Bio and Lilly contract research and development of the Xindili monoanti is intended to be listed in the U.S. market layout, the application for adaptation certificate for non-small cell lung cancer, is currently in the clinical first stage.
domestic side, Xinda's recent performance announcement shows that in 2020 Xindili single resistance completed sales of more than 2 billion yuan.
and Hengrui's internationalization is a three-fold discount, its U.S. interests first authorized to go out and then withdraw.
September 2015, Hengrui Pharmaceuticals sold its foreign interest in PD-1 antibody SHR-1210 with independent intellectual property rights to Incyte, U.S., for the first time by a Chinese company to transfer innovative biopharmaceuticals abroad with a down payment of $25 million plus a total of $770 million.
in February 2018, Hengrui Pharmaceuticals' agreement with Incyte to develop PD-1 antibodies was terminated.
to withdraw its overseas interests, Hengrui Pharmaceuticals decided to independently promote international multi-center clinical trials, including in the United States.
Hengrui's official website shows that the company has six major research and development centers, the United States Hengrui was founded in 2005, it is understood that the United States research and development center is mainly engaged in clinical research of new drugs, new drug technology projects introduced or transferred, and responsible for the FDA to declare and register drugs.
2011, Hengrui's anti-tumor drug, ErichCon, has been approved by the FDA for sale in the United States, the first product ever sold in the United States.
year to the end of 2019, Hengrui's overseas revenue accounted for 2.72%, or about 633 million yuan.
GBI data show that Hengrui overseas has a randomized, controlled, open, international multi-center Phase III clinical study on PD-1 antibody SHR-1210 combined with apatinist bisoraphine for the first-line treatment of advanced hepatocellular carcinoma, with multiple centers including China and the United States.
, the target number of international experiments was 510, and the number of participants is now 214, with the first participants joining on 10 June 2019.
as of this date, the clinic did not send more relevant clinical progress news to the FDA in the United States.
, however, on April 20, 2020, Karelli Pearl Re-authorization of its PD-1 to Korea's Crystal Genomics (CG) for $87.75 million.
agreement states that CG will receive the exclusive clinical development, registration and marketing rights of Henri Pharmaceuticals' PD-1 antibody injection kariliju monoantigen in Korea for research and development and sale of Karelli pearl monoantigen for all human diseases.
note that in this partnership, Hengrui Pharmaceuticals also announced the establishment of a joint management committee with CG to conduct strategic supervision of the development and marketing of licensed products.
Joint Management Committee consists of three representatives of Hengrui and three representatives of CG.
agreement will continue until the end of the sales schedule unless terminated early as agreed by both parties.
is not hard to guess, this may be Hengrui Pharmaceuticals experienced the termination of cooperation with Incyte, re-authorization overseas response.