apollobio: drug approvals at same time in u.s. and china
——cancer and heart and liver diseases in thefiring line, hao nan reports.
abiomedicalinvestment company in beijing says it believes it can cut the waiting time fora pharmaceutical
drugapproved in the united states to make its chinese mainland debut from eightyears to none at all.
“apollobiois developing a fast track for u.s. biomedicine companies to enter chinesemarkets and helping chinese patients receive faster and more efficient medicaltreatment,” said qiu sinian, the company’s chairman.
thecompany launched the project, called by the same name, this year that, like theu.s. apollo space programs, will help launch a new era, this time in medicine,he said.
it normally takes eight years for overseas medications to receive clearance to be sold in china because of lengthy clinical trials and approval processes.
theproject also aims to create a model for collaboration between chinese and u.s.pharmaceutical companies, he said. the project will target nasdaq-listed u.s.companies that have drugs in the third phase of clinical trials in order tolimit investment risks. according to “getting pharmaceutical r&d back ontarget”, published in the nature chemical biology journal in 2011, about 53 percent of drugs in the third phase will likely be approved by the u.s. food anddrug administration.
drugsin three fields — cancers and cardiovascular and liver diseases — will be thefocus of the apollobio project.
“many chinese people suffer from these three kinds of diseases and urgently need better medicine,” mr. qiu said.
china has at least 130 million carriers of hepatitis b, 260 million patients with acardiovascular disease and 30 million tumor patients, according to guangzhoupico, one of china’s leading pharmaceutical market research institutes.
the apollobio project is simple: the company buys the patents of the u.s.-madedrugs and acquires the exclusive license. the company enters exclusive license agreements with u.s. bio-pharmaceutical companies and obtains exclusive rightsto develop, make and commercialize their drugs in china.
the company is now negotiating with four u.s. biomedical companies, and when agreement is reached, apollobio will apply for clinical trials of those drugsin china.
chen mingjian, founder of hollyhigh, financial adviser company of apollobio,speaking of the company’s strategy, said: “the aim is to bring together thebest technology from the u.s. and the best capital and market opportunities inchina to create a bigger and better company.”
hollyhigh is a chinese investment bank that was founded 18 years ago. late last year thechina food and drug administration adopted aseries of measures aimed at overhauling the drug review and approval system.
the cfda said investigational new drugs will be handled faster if the chineseapplicant “has filed the same application in the united states or in theeuropean union and the application was approved”.
for new drugs believed to have significant clinical value and that have not beensold in china, the cfda will grant the foreign drugmaker priority status. otherdrugs that receive the same priority include drugs for preventing and treatinghiv/aids, malignant tumors, rare diseases and severe infectious diseases.
in february, apollobio announced that it had gained a listing on china’s nationalequities exchange and quotations, the neeq, also known as the new third board.it plans to raise $500 million in investment for the project. it has raised 800million yuan ($123.3 million) so far.
manyu.s. biomedical companies, though interested in the project, are unsure whetherapollobio is capable of commercializing their drugs in china. apollobio hascollaborative relationships with three chinese industrial investors inresearch, production and marketing, mr. qiu said.
“shandong jincheng pharmaceutical will be responsible for making drugs, and join town pharmaceutical group has china’s largest marketing and logistics networks in the industry,” he said. haikouvaccine technology inc will be the research and development platform.
the neeq will provide opportunities to raise funds and draw r&d companies thathave benefited from china’s emerging capital market since last year, mr. qiusaid.
thecompany is also working with hong kong morningside ventures, which gives adviceon choosing drug projects in the u.s.
“morningsidehas ample experience in investing in foreign biomedicine companies,” qiu said.“we have invited several top experts and scientists to join the committee,including venture capital pioneer pitch johnson, project initiator chenmingjian and two key opinion leaders in liver diseases.”
theapollobio project is expected to build stronger ties between china and u.s. intheir partnership in the biomedical sector, including hepatology, insiders say.
johnsonsaid the future of global pharmaceutical lies in gene treatment. cancertreatment is creating ample business opportunities. he expects chinese andtheir u.s. counterparts to build mutual trust through the apollobio project.
onapril 12 apollobio teamed up with beijing remote horizon group, the country’sleading remote medical service firm, and the asia- pacific alliance of liverdiseases, the world’s largest liver diseases doctor’s alliance, to launch aproject called defeat hbv. the three have said they will find a cure forhepatitis b in china.
thecampaign is touted as the chinese version of the jade ribbon project, an eventinitiated by the asia liver center and the school of medicine at stanforduniversity in 2001.
itused the chinese character ren as a symbol, aiming to raise awareness amongasians, of hepatitis b.what they say
chineseresearchers in medicine talk about apollobio’s ambitious move to acquire theexclusive distribution rights to u.s.-made pharmaceutical drugs.
“aspecial vaccine for children’s pneumonia was adopted in the united states 10years ago but we still need to import it from the country.we expect a vaccineto help both chinese and u.s. children simultaneously. that’s why i appreciatethe apollobio project. if it succeeds, it could benefit generations upongenerations. a grand project needs big-picture investors and high-levelresearch organs.”
luyichen, former principal research scientist at harvardt.h.chan school of public health, and president of haikou vti biologicalinstitute in haikou, hainan province
“i was impressed by the apollobio project. it could significantly benefit thetreatment of hepatitis in china. the $5 million investment in research for theproject is expected to accelerate new drug research and development.”