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1、Chinese drug makers increasingly looking abroad中国中国制药商越来越把目光投向海外制药商越来越把目光投向海外2015年成立的中国初创企业加科思制药最近从全球制药巨头艾伯维获得了2000 万美元的里程碑付款，这是加科思和艾伯维在 2020 年合作开始时支付的4500 万美元首期预付款之后的第一笔里程碑付款。Chinese startup Jacobio Pharmaceuticals,founded in 2015,recentlyreceived a$20 million milestone payment from global pharmace
2、utical giantAbbVie,marking the first milestone payment following the initial upfrontfee of$45 million at the outset of Jacobio and AbbVies collaboration inkedin 2020.The Hong Kong-listed startup is mainly engaged in the research anddevelopment of new drugs at the clinical stage.Its main drug develop
3、mentprojects include JAB-3068 and JAB-3312.Source:https:/ milestone payment was triggered by the inoculations of the firsttwo patients in the Phase-1/2 clinical trial of its SHP2 inhibitor JAB-3312 incombination with PD-1 antibody pembrolizumab and MEK inhibitorbinimetinib,respectively.SHP2 is an on
4、coprotein associated with multiple cancers,as well as apotential immunomodulator.Inhibiting SHP2 activity is therefore ofsignificant therapeutic interest as it can potentially reduce cancer cell growthand modulate immune responses to generate antitumor activities.Jacobio is just one of an emerging g
5、roup of Chinese pharmaceuticalcompanies with ambitions to rely on in-house discoveries and developglobal-standard first-in-class and best-in-class therapies.Such companiesare mostly biotech and biopharmaceutical startups.Many of them have been able to out-license their innovative productsto big-name
6、 pharmaceutical giants rather than focusing on in-licensing.Jacobio entered into a licensing agreement with AbbVie in May 2020to develop and commercialize SHP2 inhibitors,including JAB-3068 andJAB-3312.According to the collaboration agreement,AbbVie will be granted anexclusive license to the SHP2 po
7、rtfolio.Jacobio will continue to conductearly global clinical trials of JAB-3068 and JAB-3312 inhibitors,whileAbbVie will cover the R&D expenses.Upon completion of the trials,AbbVie will be in charge of globaldevelopment and commercialization.Jacobio will exclusively develop andcommercialize the SHP
8、2 inhibitors in the Chinese mainland,Hong Kongand Macao.Jacobio will also receive royalties from AbbVie from globalsales.Wang Yinxiang,chairman and CEO of Jacobio,said the company isthe second drug developer in the world to engage in clinical development ofan SHP2 inhibitor drug candidate,following
9、Novartis.JAB-3068 received investigational new drug approval from the USFood and Drug Administration to enter clinical development in January2018.JAB-3312 received investigational new drug approval from both theUSFDA and Chinas National Medical Products Administration in 2019.As of late June,there w
10、ere only six companies worldwide with SHP2inhibitors undergoing clinical trials,Wang said.When establishing the company,it was clear for us that we must focuson the global market,and to that end,only global-standard first-in-classdrugs,rather than me too approaches,will work.It will be of limited va
11、luefor Chinese companies to develop fast-follower drugs,and for the nextdecade,opportunitieswillmainlybeforcompaniesthatdevelopglobal-standard first-in-class drugs,he said.Since embarking on the collaboration,the company has been workingwith AbbVie to accelerate the global development of its SHP2 in
12、hibitors inclinical trials via either monotherapy or in combination therapy modalities atmore than 30 sites globally.The company has several projects to file for investigational new drugapprovals between 2021 and 2022,Wang said.According to Liu Jubo,CEO of Chinese biologics company EviveBiotech,the
13、nations pharmaceutical industry has been shifting from mainlyproducing generics to innovation-driven novel drug development,and strongindependent R&D capability will be the core competence of companiesseeking to achieve sustainable growth or expand their global footprint.Evive recently filed its Bio
14、logics License Application for Ryzneuta(also known as F-627)with the USFDA,following successful conclusion ofglobal Phase-3 clinical trials that met primary and secondary endpoints.Source:https:/ drug is a novel treatment for chemotherapy-induced neutropeniaa common side effect of many forms of chem
15、otherapy characterized by lowlevels of neutrophils,a type of white blood cell that fights infections.A record 271 cross-border licensing partnerships were concluded lastyearbetweenChinesepharmaceuticalcompaniesandmultinationalcompanies,including Roche,Bayer,AbbVie and Pfizer,data from ChinaBioshowed
16、.ChinaBio is a Shanghai-based consulting and advisory firmfocusing on the domestic life sciences industry.The figure represented an increase of nearly 50 percent from 2019 andmore than 300 percent from 2015.The largest out-licensing deal in 2020 was I-Mab BiopharmaspartnershipwithglobaldrugmakerAbbV
17、ieIncfortherightstolemzoparlimabalso known as TJC4which is an anti-CD47 monoclonalantibody discovered by the Shanghai-based company to treat multiple formsof cancer.Anti-CD47 therapies are one of the most competitive branches incancer drug development.The therapies target a signal that allows cancer
18、cells to avoid being attacked by the patients own immune system.According to the announcement in September 2020,the deal wasestimated to be worth more than$2.9 billion.In January this year,BeiGene Ltd and Novartis entered a collaborationand licensing agreement granting Novartis rights to develop,man
19、ufactureand commercialize anti-PD-1 antibody tislelizumab in North America,Europe and Japan.BeiGene will receive$2.2 billion from Novartis for the arrangement.The upfront cash payment will be$650 million and the company is eligibleto receive up to$1.3 billion on reaching regulatory milestones,and$25
20、0million on achieving sales milestones,in addition to royalties on future salesof tislelizumab in licensed territories.Although most of the licensing deals between Chinese pharmaceuticalcompanies and their foreign counterparts are in-licensing,the out-licensingdealsareseeingquickgrowthbecauseChinese
21、biotechandbiopharmaceutical companies now eye not only the domestic market,butalso the global market,industry experts said.Chinas biopharmaceutical industry has made enough breakthroughs tobe able to conduct research and development for cutting-edge drugs.Also,itneeds broader space than merely the d
22、omestic market to grow bigger,theysaid.Already the second-largest pharmaceutical market in the world,Chinasprescription drug market totaled 1.2 trillion yuan in 2020 sales,which,ifexcluding patent drugs of traditional Chinese medicine and generics,wasonly about 70 billion yuan.That was much smaller
23、than the US markets$900 billion,said Feng Ting,vice-president of Lilly Asia Ventures.The future of Chinese innovative pharmaceutical companies relies onsuccessful global operations,because that is the only way for Chinesepharmaceutical companies to grow into international pharmaceutical giants,said
24、Wu Xiaobin,president of BeiGene.Tislelizumab is the first drug from BeiGenes immuno-oncologybiologics program being developed globally for the treatment of a broadarray of both solid tumor and hematologic cancers.The company has established a strong global product R&D andcommercialization system,as
25、well as advanced facilities and manufacturingtechniques for production to support the launch and commercialization ofmore innovative drugs in overseas markets.In November 2019,its Brukinsa(zanubrutinib)was approved by theUSFDA to treat mantle cell lymphoma in adult patients,marking the firstcancer t
26、reatment developed in China to be approved for the US market.As of March,clinical trials conducted or planned by the companytotaledmorethan100,including25Phase-3orpotentiallyregistration-enabling clinical trials.Chinas innovative drug industry is undergoing a golden age ofdevelopment because China h
27、as made great progress in encouraging thedevelopment of innovative drugs,especially in terms of attracting andcultivating talent and improving the regulatory environment,she said.It used to take an average of three years for an innovative drug to getinvestigational new drug approval in the past.Now the time span hasnarrowed to about three months,Tang added.References:1.https:/ accessed on July 13,2021.2.https:/ accessed on July 13,2021.