When a small drug maker here got U.S. Food and Drug Administration approval for an AIDS drug this past summer, the Chinese pharmaceutical industry quietly passed an important milestone. As far as the...
When a small drug maker here got U.S. Food and Drug Administration approval for an AIDS drug this past summer, the Chinese pharmaceutical industry quietly passed an important milestone. As far as the agency can tell, it is the first time a Chinese drug company has won permission to export finished drugs to the U.S.Expect a lot more pharmaceutical makers here to get the green light over the next few years. Even as Chinese products are drawing increased scrutiny, the nation's generic-drug industry is gearing up for the export of finished medicines. It is still small -- India's generics-export powerhouse is 10 times as big. But China is already the world's largest producer of raw materials for drugs, and manufacturing those raw materials is a stepping-stone to making the completed product.That is what happened at Ranbaxy Laboratories Ltd. India's biggest Indian pharmaceutical company by sales started out in 1961 making drug ingredients. In 1988, a Ranbaxy plant in Toansa, India, won FDA approval to export raw pharmaceutical ingredients to the U.S. Ten years later, Ranbaxy launched the first of its own products, the antibiotic cefaclor, in the U.S. following FDA approval. Now, North America is the company's largest market, contributing $391 million in revenue to its $1.34 billion total for last year.Zhejiang Huahai Pharmaceutical Co., the domestically listed Chinese drug maker that won FDA approval this summer, is 'exactly an example of a Chinese company today attacking the developed markets,' says Yusuf Hamied, chairman of Cipla Ltd., one of India's top drug companies.Dr. Hamied calls the Chinese 'brilliant scientists and brilliant chemists' and warns that 'India is no match for them if they pick up their English language and pick up a little on regulatory approvals, which they're doing very fast anyway. They are a major, major threat to India, no doubt about it.'To export its medicine, Huahai must wait until May 2012, when a U.S. patent held by Boehringer Ingelheim GmbH for the AIDS drug nevirapine, which the German company markets under the brand name Viramune, is set to expire. But the FDA imprimatur will make it easier for Huahai to get other approvals and attract American drug partners. Huahai now hopes to replicate its FDA performance with other pharmaceutical products and to start exporting a finished-dosage Alzheimer's drug to Europe as early as next year.Huahai, for the time being, doesn't plan on following in the footsteps of the Indian generics titans that revolutionized an industry by actively challenging the patents of blockbuster drugs in the courts. 'Currently, we don't think we have that kind of capability or technical knowledge of doing a patent,' says Jessica Yu, Huahai's regional representative for North American and Japanese drug sales. 'It costs a lot of money and what we are focusing so far is manufacturing.'Huahai currently sells nevirapine to the Chinese government for around $3.50 for one bottle of 60, 200-milligram pills. The company hopes to bid through the Clinton Foundation to sell drugs to Africa. The Clinton Foundation didn't reply to a request for comment.Whether or not it meets that goal of exporting finished products, the Huahai nevirapine approval is likely to be the starting point of any time line drawn years from now, when China's finished-generics industry is likely to have become a force to reckon with.Major markets already depend on China for raw drug ingredients, as well as for commodities like vitamin C, for which Chinese manufacturers provide more than 85% of the supply used in the U.S. With it's low costs, China has become the world's largest exporter of raw ingredients for pharmaceuticals. Indeed, China's growing dominance in manufacturing is steadily increasing its power to set the prices of a wide variety of industrial and consumer products. Konda Reddy, a health-care analyst in India for Frost & Sullivan, a research and consulting firm, says Chinese prices for raw pharmaceutical materials are already 10% to 15% below those of their Indian rivals.Previously 'the Europeans were afraid of India,' says Jinsong Du, a health-care analyst in Hong Kong with Credit Suisse. Now, he says, 'it's China; the growth is so huge.'The current alarm over toxic drugs, toiletries and toys from China could pose a major marketing challenge to China's would-be generics-export industry. For the past year, China's own drug-regulatory agency, the State Food and Drug Administration, has been embroiled in a huge corruption investigation, culminating in the execution of its former chief, Zheng Xiaoyu, in July for taking bribes from drug companies to speed approvals, the same month Huahai won its FDA approval.In the spring of 2006, at least 11 people fell ill and five of them died after taking injections of a medicine used to treat inflammation of the gallbladder made by Qiqihar No. 2 Pharmaceutical Co. because the company, to save money, had used diethylene glycol -- the same chemical that the FDA said recently might be in toothpaste produced in China.Increased scrutiny of goods made in China could complicate the effort of Huahai and other Chinese companies to sell their products overseas. One Huahai customer, Kraemer & Martin GmbH in Germany, declined to comment on its relationship with the company, while another prospective partner didn't reply to a request for comment.Still, the green light for Huahai's AIDS drug, granted even amid the outcry over the Chinese exports, suggests the mechanism is in place for the country's pharmaceutical-export industry to grow. The raw materials so far have continued to flow, and major companies stand by their Chinese sourcing.'Our global head of operations comes here every year just to make sure that this relationship and this supply are reliable,' says Yin Xudong, AstraZeneca PLC's vice president of primary care for in China. Chinese drug companies are the main suppliers of the raw ingredients needed to make AstraZeneca's Seroquel, a blockbuster that is used to treat schizophrenia and other mental disorders, according to Mr. Yin. Sales of the drug were $3.4 billion last year.China is struggling to stem a steady flow of counterfeit drugs; fake Viagra tablets, for instance, can be bought in airport lounges here. But even though enforcement can be spotty or even nonexistent, the country does have relatively strict laws that, at least on paper, protect drug patents. That situation stands in stark contrast to lax patent laws that were the norm for years in India and allowed a generation of Indian drug companies to thrive by churning out cheap copycat pills with impunity.'Inside China, the intellectual-property rights, as far as the drug patents are concerned, are actually good in terms of the actual laws,' says Mr. Yin. 'The enforcement may have a problem. We will see counterfeits. But the Chinese SFDA will not issue a new drug license for a compound that we already have a patent for. That will not happen.' As a result, he says, 'We don't see this as a major threat to us.'Over the past three decades, Indian generic-drug makers such as Cipla, Ranbaxy and Dr. Reddy's Laboratories Ltd. have made over the industry by competing fiercely with Western multinationals over drug pricing. The implications have been profound not just for the industry but for consumers, who can purchase cheaper Indian versions of the drugs their doctors prescribe.India's share of the finished-generics export market, at around $4 billion in 2005, still dwarfs China's, which was $380 million for the same period. But because it had such a small base in 2004, that was up 23%, according to figures compiled by Credit Suisse.China also had 14% of the $31 billion market for raw pharmaceutical materials, known as active pharmaceutical ingredients, or APIs, as of 2005. That compares with India's 6%. China's rise could threaten other countries, too. Italy, for example, at 10%, is the second-biggest producer of raw pharmaceutical materials.The pharmaceutical food chain consists of companies that manufacture the chemicals needed to produce ingredients, the ingredients themselves, the finished generic drugs -- China's new horizon -- and, finally, the companies that invent new drugs. There are 906 Chinese companies with active pharmaceutical ingredients listed in the FDA's drug-registration database, according to Christopher C. Kelly, a spokesman for the FDA in Washington.There are other Chinese companies hoping to win a share of the generics market. Most, like Huahai, are raw-materials exporters aiming to travel up the food chain. For example, Hisun Pharmaceutical Co., established in 1956, is now one of China's largest producers of APIs. And Shanghai Desano Chemical Pharmaceutical Co. exports materials for AIDS drugs to India, Thailand and Brazil.Huahai, based in Linhai, on China's eastern coast, was founded by Chen Baohua in 1989. He started the company with an initial investment of around $5,000 and 12 employees mixing chemicals in a one-room warehouse. The 44-year-old Mr. Chen now owns 27% of the company's stock and manages Huahai's 2,200 employees.Huahai used to focus on hypertension drugs but now makes a stable of generic medicines. Though still very small, it saw sales nearly triple to 557 million yuanlast year from 187 million Chinese yuan in 2002. The company's profit has more than doubled in that same period, rising to 110 million yuan from 50 million yuan. The stock price has also soared in recent years. Huahai currently gets 90% of its revenue from APIs, most of which are exported to drug companies in more than 30 countries.In April, the FDA sent two officials to inspect Huahai's finished-dosage factory. Xu Pijie, the 42-year-old plant manager, remembers the officials asking hard questions and giving specific advice on how to improve the manufacturing processes.'They had very detailed specifications about how to wash all the equipment,' Mr. Xu says. 'I was a little nervous.'今年夏季，中国浙江临海的一家小药厂──浙江华海药业股份有限公司生产的抗艾滋病药物获得了美国食品和药物管理局的认证，不经意间，中国的制药业也平静地通过了一个重要的里程碑。FDA迄今为止的数据显示，这是中国制药企业首次获准向美国出口成品药。 预计今后几年里将有更多的中国制药企业获得FDA的绿灯。尽管中国产品的质量引起了越来越多的关注，但中国的仿制药行业正在大力推进成品药的出口。中国在这方面刚刚起步──印度的仿制药出口规模是中国的10倍。不过，中国已经是世界上最大的原料药生产国，而原材料加工是生产成品药的基础。 这也是印度Ranbaxy Laboratories Ltd.走过的道路。这家印度销售额最大的制药企业成立于1961年，当初也是主要生产原料药。1988年，Ranbaxy在印度Toansa的一家工厂获得了FDA的认证，得以向美国出口原料药。10年后，在得到FDA批准后，Ranbaxy在美国推出了首个自己的产品──抗生素头孢克洛。如今，北美已成为这家企业最大的市场，去年该公司的总收入为13.4亿美元，其中有3.91亿美元来自北美。 印度最大制药企业之一Cipla Ltd.的董事长尤素福
