Anti-PD-1 Innovative Drugs-Inspiration from Sea Strategies

1.Hengrui Medicineof"Double Ai"Portfolio to total6Billions of dollarsSailor

2023Year10Month17day,Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to"Hengrui Medicine")Announce,Will be independently developed and have intellectual property rights.1class of new drugs,programmed death receptor-1(Programmed cellDeath protein 1, PD-1)The inhibitor carrilizumab (trade name: erica®)withRivoceranib(Domestic marketed product name is apatinib,Trade name: Eitan®) Joint(hereinafter referred to“Double Ai”Combination)for the treatment of hepatocellular carcinomaPaid License to U. S.Elevar Therapeutics Inc.(hereinafter referred to“Elevar Therapeutics”）,Elevate Therapeut"Double Ai"CombinationExclusive rights for the treatment of hepatocellular carcinoma.

Under the terms of the agreement, based on the initial marketing approval and actual annual net sales of karelizumab in the United States, Japan and the agreed European countries, respectively,Elevar TherapeuticsWill be after reaching a certain cumulative net salesTo HengruiMedicinePayment Accumulation6Sales milestones of $100 million and additional payments beyond a certain cumulative net sales, plus actual annual net sales20.5%of sales commission.HengruiMedicinewithElevar TherapeuticsThe further cooperation reached will strongly promote the global promotion of the "double AI" combination of liver cancer indications, and is expected to benefit more patients around the world.

In the above case, the way the enterprise uses to go to seaYes“Borrowing a boat to go to sea”,The first thing to "borrow a boat to go to sea" is to have excellent products, followed by finding suitable and reliable partners and being able to grasp the time node for cooperation with external parties.

2.HundredJi Shenzhouof Trellizumab out to sea

Terelizumab (trade name: Baizeran) is a humanized productIgG4resistancePD-1monoclonal antibody,designed to minimize the association of macrophagesFcγThe receptor binds to help the body's immune cells detect and fight tumors. Preclinical data suggest thatFcγReceptor binding activates antibody-dependent cell-mediated killingTcells, thereby reducing the resistancePD-1Antitumor activity of antibodies. At present, the global clinical development program of trellizumab has exceeded.30countries and regions to carry out more20Item registration-related trials, enrolled more1.2million patients.

2023Year9Month19Day, Baiji Shenzhou announcedThe European Commission (EC) Trellizumab has been approvedAs a monotherapy for the treatment of unresectable, locally advanced or metastatic esophageal squamous cell carcinoma with prior platinum-containing chemotherapy (ESCC) Adult patients.S. Food and Drug Administration (FDA) has also accepted TrellizumabOne marketing approval application for first-line treatment of unresectable locally advanced, recurrent or metastaticESCCPatients.

In the above case, the way the enterprise uses to go to seaYes“Shipbuilding to sea”,The first thing in "shipbuilding to sea" is a forward-looking global layout,For example, Baekje Shenzhou set a global goal at the beginning of product development, layout of global multi-center clinical research, and the control group took into account the differences in the practice of chemotherapy for esophageal squamous cell carcinoma in different countries and regions;The second is to deal with the pricing challenges of going out to sea,If the global pricing of drugs is subjectThe impact of "home country" drug prices, on this,Baiji ShenzhouPerhaps we can learn from the United States."Provide drug price concessions by means of discounts or rebates" to avoid disclosing the actual pricing of drugs, and the actual cost of treatment for patients is not equivalent to the real price of drugs..

The above summary hopes to bring some new inspiration to innovative pharmaceutical companies that want to go to sea.