On September 13, the pharmaceutical network has successfully completed the d-round financing, which shows that the mainstream investment institutions of China's health industry have begun to lay out the local enterprises of high-end preparations. After the long wind industry is funded, it will be introduced by the national "thousand talents program" to develop the inhalation preparations for treatment of respiratory diseases.
In recent years, domestic pharmaceutical companies are rapidly running around the country by seizing the opportunity of patent expiration for multinational drug companies. In the case of hengrui, which has made great progress in the internationalization of preparations, it has been approved by the United States FDA for the application of the multi-sidesai injection ANDA application, which is 20mg/ 1ml, 80mg/4ml and 160mg/8ml respectively. Products with a size of 40mg/ml have been approved in the us on February 15 this year.
Under the promotion of national internationalization strategy, the scale of Chinese generic drug "go to sea" is expanding, but the number of enterprises participating in the international division of labor is numbered.
To have money and talent strength of the local pharmaceutical companies, pharmaceutical preparations internationalization is go the way of imitation, or the road of innovation, is a question to answer, this relationship with China's pharmaceutical industry is a place in the international innovation, or on the path of similar to India.
Chinese medicine and health products import and export chamber of commerce, vice President of Xu Ming said: "China pharmaceutical enterprise internationalization of the road is not easy, after all, most companies from API to formulations, on sales of change too much, need to involve too many factors, has too many difficulties, such as wholesalers, retail companies, insurance companies, government departments, both need to gradually accumulate experience, and also need help from the partner."
Imitation is not a long-term solution
At present, the most notable in the international field of preparation is hengrui medicine and zhengda tianqing. Internationalization is a top priority in the strategy of hengrui medicine, which is an important step to prove innovation ability. So far, the company has officially approved the seventh ANDA number in the United States.
In 2016, hengrui pharmaceuticals earned less than 500 million yuan in overseas market, and many in the industry believe its international business revenue will exceed 1 billion yuan this year. Characters, deputy general manager of international YanBing think: "look, from the experience of many enterprises international certification just 'ticket', to really go into the overseas market, also need to develop marketable pharmaceutical product marketing."
So far, according to the FDA's Orange Book data, a total of 13 manufacturers in the United States have been approved by the FDA. Apart from sanofi, a former research firm, there are multinational pharmaceutical giants such as Pfizer, and generics giants such as TEVA and Dr. REDDYS.
Xia chunguang, vice President of the research institute of jiangsu zhengda tianqing pharmaceutical co., LTD., also believes that if he wants to enter the overseas market, he will achieve fame and fortune. For domestic pharmaceutical companies, in terms of "name", Europe and the United States, listed permission, a sense is equal to saving the consistency evaluation, is expected in the domestic bidding market advantage; From the perspective of "li", Chinese pharmaceutical companies can open up new markets and gain greater returns by virtue of price advantage.
"In the international market, the profits of generic drugs are indeed low, and the PQ certifications represented by the WHO public market, for example, are low in return," said the head of a drug company. We had contact with WHO many years ago, and they gave us a product that quoted prices that were almost close to our cost, and the profits were too low.
Domestic experience in international cooperation
Transnational cooperation has become the first step in the international innovation of Chinese pharmaceutical enterprises. In early 2016, zhengda shine and Johnson & Johnson pharmaceutical companies in the United States signed an exclusive license agreement, will be a potential innovative drugs to cure hepatitis outside mainland China of the international rights licensed to Johnson &johnson, the drug in the preclinical development stage, Johnson &johnson will carry out the global development of the product outside China, the production, registration and commercialization.
Under the agreement, j&j will pay a total of $253 million, down payment and mileage, as well as sales commissions after the sale.
Industry insiders believe that the technology provider is China, unlike the traditional Chinese and foreign cooperation models that provide technology and Chinese enterprises to provide production and channel. And in the field of innovation medicine, it is not uncommon for Chinese companies to provide technology for the development of new drugs in global markets jointly with international giants.
Coincidentally, in December 2015, the food and drug administration awarded anrotinib an orphan drug for ovarian cancer. At present, cp and partners are conducting clinical 1b/2a studies on the treatment of ovarian and endometrial cancer in the United States. After listing, the drug has a 7 year exclusive period in the United States, indicating that it has been recognized internationally.
This model of cooperation is becoming the way most domestic pharmaceutical companies need it. According to the reporter, on the one hand, the cost of conducting international multi-center clinical trials is very high, and there is still a lot of economic pressure for local pharmaceutical companies. On the other hand, if the drugs for clinical research need to be produced in China and sent to the us for clinical treatment, the efficiency will be very low and valuable time will be wasted.
On condition of anonymity in the industry said: "we drug used for the customs formalities for the exportation of international clinical than Europe and the United States is convenient, for these drugs are not approved by the public, customs formalities will be more complicated; And in Europe and America, as long as there are clinical approvals of regulators, it can be sent to all parts of the world.
For the pioneers such as hang ray, there have been many international experiences, one of which is to make market access. In the international market, the company is not a self-built team, but in cooperation with international giants, starting from speeding up the international sales process. Since 2014, hengrui has achieved better sales results in cooperation with international well-known enterprises such as Sandoz, Teva and Sagent. In particular, the injection of cyclophosphamide, henryl, and Sandoz, one of the largest generic drug companies in the United States, are responsible for marketing and sales in the U.S. market.
It serve as a milestone for hengrui pharmaceutical, huge cyclophosphamide market bring hengrui is hundreds of millions of yuan a year profit, also become internationalization path hengrui preparations contribute large profits in the first variety.
Hengrui pharmaceutical England international affairs development director stressed: "our experience is that, in the United States must find the right dealer, in the United States is not the only Kant, this several CVS, in fact, different sizes of dealers, their respective advantages in different fields. For different distribution companies, be sure to have an objective understanding. The most important lesson is that to do well in the us market, we must optimize our relationship with our dealers and maintain good faith. American dealers also have a small circle, and if you act against integrity, you will be eliminated from the market very quickly.
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