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ApolloBio: Drug Approvals at Same Time in U.S. and China

A biomedical investment company in Beijing says it believes it can cut the waiting time for a pharmaceutical drug approved in the United States to make its Chinese mainland debut from eight years to none at all.

“ApolloBio is developing a fast track for U.S. biomedicine companies to enter Chinese markets and helping Chinese patients receive faster and more efficient medical treatment”, said Qiu Sinian, the company’s Chairman.

The company launched the project, called by the same name, this year that, like the U.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.

The project 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 to limit investment risks. According to “Getting pharmaceutical R&D Back on target”, 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 and Drug Administration.

Drugs in three fields — cancers and cardiovascular and liver diseases — will be the focus 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 a cardiovascular disease and 30 million tumour 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.-made drugs and acquires the exclusive license. The company enters exclusive license agreements with U.S. bio-pharmaceutical companies and obtains exclusive rights to 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 drugs in china.

Chen Mingjian, founder of Hollyhigh, financial adviser company of ApolloBio, speaking of the company’s strategy, said: “The aim is to bring together the best technology from the U.S. and the best capital and market opportunities in China to create a bigger and better company.”

Hollyhigh is a Chinese investment bank that was founded 18 years ago. Late last year, the China Food and Drug Administration adopted a series of measures aimed at overhauling the drug review and approval system.

The CFDA said investigational new drugs will be handled faster if the Chinese applicant “has filed the same application in the United States or in the European Union and the application was approved”.

For new drugs believed to have significant clinical value and that have not been sold in china, the CFDA will grant the foreign drugmaker priority status. Other drugs that receive the same priority include drugs for preventing and treating HIV/AIDs, malignant tumours, rare diseases and severe infectious diseases.

In February, ApolloBio announced that it had gained a listing on china’s National Equities 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.

Many U.S. biomedical companies, though interested in the project, are unsure whether ApolloBio is capable of commercializing their drugs in china. ApolloBio has collaborative relationships with three Chinese industrial investors in research, 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. Haikou Vaccine Technology Inc. will be the research and development platform.

The NeeQ will provide opportunities to raise funds and draw R&D companies that have benefited from china’s emerging capital market since last year, Mr. Qiu said.

The company is also working with Hong Kong Morningside Ventures, which gives advice on choosing drug projects in the U.s.

“Morningside has 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 Chen Mingjian and two key opinion leaders in liver diseases.”

The ApolloBio project is expected to build stronger ties between China and U.S. in their partnership in the biomedical sector, including hepatology, insiders say.

Johnson said the future of global pharmaceutical lies in gene treatment. Cancer treatment is creating ample business opportunities. He expects Chinese and their U.S. counterparts to build mutual trust through the ApolloBio project.

On April 12, ApolloBio teamed up with Beijing Remote Horizon Group, the country’s leading remote medical service firm, and the Asia-Pacific alliance of liver diseases, the world’s largest liver diseases doctor’s alliance, to launch a project called Defeat HBV. The three have said they will find a cure for Hepatitis B in China.

The campaign is touted as the Chinese version of the Jade Ribbon project, an event initiated by the Asia liver centre and the school of Medicine at Stanford University in 2001.

It used the Chinese character “Ren” as a symbol, aiming to raise awareness among Asians, of Hepatitis B.

Chinese researchers in medicine talk about ApolloBio’s ambitious move to acquire the exclusive distribution rights to U.S.-made pharmaceutical drugs.

“A special vaccine for children’s pneumonia was adopted in the United states 10 years ago but we still need to import it from the country. We expect a vaccine to help both Chinese and U.S. children simultaneously. That’s why I appreciate the ApolloBio project. If it succeeds, it could benefit generations upon generations. a grand project needs big-picture investors and high-level research organs.”

Lu Yichen, former principal research scientist at Harvard T.H. Chan school of Public Health, and President of Haikou VTi Biological Institute in Haikou, Hainan province.

“I was impressed by the ApolloBio project. It could significantly benefit the treatment of Hepatitis in China. The $5 million investment in research for the project is expected to accelerate new drug research and development”, Cheng Jun, Deputy Dean of Beijing Ditan Hospital.

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