The export of ice from pharmaceutical preparations is coming soon

Business Club September 9th The pharmaceutical companies are accelerating their integration, multinational pharmaceutical companies have entered the Chinese market, and domestic pharmaceutical companies are playing a more important role in the international pharmaceutical industry. At present, the basic conditions for the export of preparations for local pharmaceutical companies are already in place, and the timing of industrial upgrading has come. Companies that challenge successful patents are expected to enjoy the most lucrative profits in the field of generic drugs.

Exports of preparations for pharmaceutical companies in China are facing breakthroughs. The main opportunities exist at the stage of patent expiration and afterwards, including three levels of generic imitation, challenging patents, and licensing during the patent period. The core elements of competition are cost and technology. Resources. Among them, challenging patents are a comprehensive manifestation of the technical strength of generic pharmaceutical companies and are expected to bring in excess profits. Currently, only Hisun Pharmaceutical can challenge patents in China.

For most local companies, they do not have the strength to challenge patents and authorized generic drugs. Applying for or purchasing ANDA production licenses in the field of generic drugs after the expiration of patents is a realistic option for entering mainstream markets in Europe and America. The generic name drug stage generic drugs export specification market needs to meet three major conditions: 1. The product has the qualification to regulate the market sales, including the production line certification and product certification; 2. The product can have a cost advantage. Among them, the accessories and package materials with low cost and in line with European and American standards are the biggest obstacles to the current domestic product export; 3. They can be sold to terminals through unimpeded channels. In short, it is through "entry clearance, cost clearance, and sales clearance." At present, the above three barriers have already been broken or have already achieved the basis for breakthroughs.

The number of DMF documents indicates that raw material companies have entered the regulatory market. Since 2003, the number of DMF documents obtained by Chinese pharmaceutical companies in the United States has accounted for more than 10%. China has become a major global supplier of many APIs. Business, such as statins, Puli drugs, heparin and so on. Under the background of the globalization of raw material supplies, it is not impossible for pharmaceutical companies to find raw materials that meet the regulatory market standards for overseas expansion. In terms of sales, at this stage, local companies still do not have the ability to sell overseas. It can be solved by cooperation with foreign production companies or commercial enterprises, combining the other party's sales advantage with its own cost advantage, and can also make up for short-term sales by purchasing overseas companies. In foreign countries, a large number of drugs are sold through chain pharmacies. In the United States, pharmacies and mailing services account for more than 50% of sales of pharmaceuticals, unlike domestic sales of more than 70% of drugs sold in hospitals. Relatively speaking, the sale of generic drugs is not as difficult as in China. Local manufacturers can fully cooperate with foreign pharmaceutical chain companies to provide OEM or private label products when they have enough production symbols in the future.

Policies support the formulation of export companies to replenish domestic formulation business. The tax rebate rate for the export of pharmaceutical preparations has been raised from 13% to 15%; in some provinces and municipalities, companies that have the scale of preparations and export to the European and American regulatory markets can enjoy separate pricing. In the "Drug Prices Management Approach (Draft for Soliciting Opinions)" released in June 2010, it was also clearly pointed out that the government's price authority for "drugs produced in China and exported to international mainstream markets" could formulate drugs for specific companies. And adjust the price. Shenzhen Lijian and other companies have succeeded in expanding the domestic formulation market through the export of preparations. In the future, more manufacturers will choose this route.

China's raw material medicine, generic medicine, and innovative medicine companies have different ways to achieve generic brand name export. 1. Raw material medicine companies can gradually realize the export of preparations and realize the integration of raw material preparations such as Hisun, Huahai; 2. The domestic generic pharmaceutical companies rely on good raw material bases in China and are expected to directly cross raw material exports and realize the export of preparations. , such as Renfu, East China, etc.; 3. Innovative drug companies may implement agent exports at the patent drug level, such as Hengrui Pharmaceutical. We recommend investors to invest heavily in investing in Hisun Pharmaceutical, Renfu Pharmaceutical and Hengrui Pharmaceutical. At the same time, it is advisable to pay attention to other companies that have the potential to realize the export of formulations, such as Jingxin Pharmaceutical and Meiluo Pharmaceutical.

What needs to be reminded is that China's generic drug exports are at risk of fluctuations in their performance. As a new entrant to the international market, its sales scale cannot temporarily compete with foreign large-scale pharmaceutical manufacturers. It requires a certain amount of time to adapt to the sales methods and channels, and faces the risk of performance fluctuations.