Wei Kang was in a very good mood. This time, the only company in the world with a specific AD drug had created such a huge momentum. He had lost his mind and authorized the drug.
As an adult, of course it is best to keep it firmly in your own hands.
As for the previous anti-cancer drugs, Sanqing was still very weak at that time. It needed money but no money, needed people and no one. It still owed a lot of debt and was just waiting for the rice to fall into the pot. At that time, of course, it was necessary to cash out as soon as possible to get the first pot of gold. Just get a return on investment.
There is no rush now. Sanqing is already a large pharmaceutical company with money, people, and various resources. Of course, it has to start on its own and take advantage of the grand momentum to fully promote the overseas market.
Generally speaking, to enter the market of each country, you need to apply to the local drug regulatory department. Different regions adopt different standards and regulations. Entering the Eagle Country market requires passing the FDA, entering the Chinese market requires passing the CFDA, entering the Europa market requires CE certification, and entering the fur bear market also requires medical registration.
The authority of the FDA is reflected. If a drug is approved for sale by the FDA, it can almost open the door to most overseas countries. Although other countries also have their own drug review standards, they basically refer to the clinical data and standards of the FDA. .
There are probably several corresponding strategies for domestic pharmaceutical companies to enter overseas pharmaceutical markets, especially the Eagle Country market.
The first is to authorize joint development, commonly known as license out.
Companies with high-value research and development products often choose to jointly develop and promote products with local pharmaceutical companies in order to speed up the development and approval of products overseas. This cooperation model can obtain direct benefits due to milestone payments, and is the model chosen by most domestic pharmaceutical companies. .
Because the research and development of new drugs often involves a narrow escape, the investment is huge, and many pharmaceutical companies cannot survive. Therefore, they must recover the cost as soon as they have results, and authorized development is undoubtedly the best option.
Anticancer drugs before Sanqing chose this model.
Other domestic pharmaceutical companies also have many classic cases in this regard.
For example, the global cooperation agreement signed by BeiGene and Merck Serono in 2013 to jointly develop the second-generation braf inhibitor bgb-283 brought BeiGene a large amount of funds at a critical moment. Saved BeiGene at the critical moment.
The second is to set up overseas companies for independent research and development.
Some pharmaceutical companies have strong comprehensive strength and often choose to apply to the FDA themselves. If the drug is approved, the rights and interests will belong to them. At present, some large domestic pharmaceutical companies have obviously tasted the sweetness and have continued to work hard in this regard with fruitful results.
For example, Hengrui Pharmaceuticals, a leading domestic pharmaceutical company, has established a subsidiary company Hengrui Therapeutics in Yingguo to engage in project introduction and drug discovery activities. The company's drug candidates initially include three tumor drug candidates isolated from Hengrui, pyrotinib, shr-a1201, and shr1210 (PD1 monoclonal antibody).
In 2016, the company received a US$100 million investment from Hengrui Pharmaceuticals and an undisclosed blue-chip investment institution. Over the past 17 years, three of the four innovative drugs of Hengrui Pharmaceuticals that have been approved for clinical trials in Eagle Country have been submitted by its subsidiary Hengrui Therapeutics.
The third and final method is to apply for local funding in the country.
Such companies often refer to generic drug companies, and the declared varieties are generic drugs. The declaration of generic drugs is simpler than that of innovative drugs. Companies often do not choose to establish overseas subsidiaries, and there is no authorization for generic drugs. Therefore, most companies choose to declare to the FDA domestically, or choose a suitable Eagle Country service agency to assist in the filing.
This is because the original drugs from overseas pharmaceutical companies are very expensive, so the FDA will open clinical applications to cheap and high-quality generic drugs from other countries and approve them for marketing to reduce the burden on patients.
For example, the famous Tianzhu generic drugs are very popular in Eagle Country and have occupied 42% of the local generic drug market share.
There are also many domestic pharmaceutical companies involved. For example, Dongguang Pharmaceutical applied to the FDA last year for a new drug application for the anti-diabetic drug linagliptin (also known as Yingguo generic drug application) and was approved.
Develop an overseas expansion strategy and obtain approval from the FDA and other countries' drug regulatory agencies.
The subsequent commercial development of new drugs is also very important, which is mainly divided into two parts: promotion and sales.
When a drug is approved by the FDA, those products that have been authorized for transfer and have overseas partners will be developed through the partners for distribution and market development. For most pharmaceutical companies that have not cooperated before approval, they choose to be distributors and distributors themselves. Terminal pharmacy development.
Follow-up development is divided into two aspects, just like a person's left and right legs, both are indispensable. Both aspects need to work together to maximize the commercial sales of the drug.
One aspect is overall branding.
As the saying goes, food and grass must go first before troops are deployed. After a drug is approved, whether at home or abroad, it needs the strong support of KOL public figures.
In China, pharmaceutical companies will invite doctors to host or participate in launch meetings to lay the foundation for future products.
Also in Eagle Country, before and after a drug is approved, overall market promotion of the drug is a necessary part of the company's work.
In addition to educating the market and letting more doctors and patients know about product approval information, the extensive information exposure on social media also lays the foundation for later search for distributor partners and increases the bargaining chips.
In terms of promotion focus, innovative drugs emphasize the advantages and value of drugs, while generic drugs emphasize the cost-effectiveness of drugs. Price wars have a natural advantage for China, a rising star.
On the other hand, we are looking for partners, including distributors, pharmacies and hospitals.
In addition to the leading companies that have been approved, most domestic pharmaceutical companies have a weak foundation in this area and need continuous accumulation.
Enterprises can find partners on their own, or they can choose to cooperate with professional service organizations to complement each other's advantages, gain time to establish cooperation with local dealers as soon as possible, and enable products to achieve sales results as soon as possible.
The pharmaceutical sales market in overseas countries is very different from that in China. Most domestic drugs are controlled by hospitals, and pharmacies only serve as a supplement to some over-the-counter drugs.
In the pharmaceutical market of Eagle Country, hospital medicines are mainly concentrated on the inpatient side, while the retail side composed of distributors and retail pharmacies is the bulk of drug sales.
In 2018, Eagle Country’s medical expenditure reached 18.9% of the national GDP, US$3.7 trillion, of which prescription drug expenditure accounted for 12%. The entire prescription drug market is approximately US$440 billion, with an average of 12 prescriptions issued per person per year and per capita consumption of US$1,150.
Patients in Eagle Country seek medical treatment from doctors. Doctors can only write prescriptions and cannot sell medicines in hospitals or their own clinics. Patients can go to any pharmacy to buy the medicines they need after receiving a prescription. The cost is borne by the patient and insurance (government medical insurance). + commercial insurance) is paid on a pro-rata basis.
The process is simple, but the drug sales system behind it is very complex, reflecting a complex chain of interests.
In the entire drug sales chain, pharmaceutical companies earn approximately 70% of the revenue. Some analysts believe that the profits from Eagle Country's patented drugs even exceed those of the tobacco industry.
Monopoly operation, free pricing and insurance payment have made Eagle Country the largest drug consumer and the largest drug market in the world. Pharmaceutical manufacturers around the world are all eager to try their skills in Eagle Country.
Soon after, Sanqing issued another announcement on its official website, announcing the official establishment of Sanqing’s overseas subsidiary.
"The overseas subsidiary of Sanqing Pharmaceutical has been officially established recently and is recruiting talented people. We welcome capable, courageous, and enterprising pharmaceutical industry talents to apply and join in this great event."
"The internationalization process of domestic pharmaceutical companies is like a river flowing eastward, and we are moving forward in this torrent. In the near future, Sanqing Pharmaceutical's overseas sales market will continue to make breakthroughs and reach new highs. And then create a truly world-class pharmaceutical company."
This time Sanqing goes overseas, in addition to clinical application work, expanding overseas distributors and retail pharmacies, and building a local sales team are top priorities.
At the same time, a wave of recruitment of international talents has also been launched. Due to the reputation of the new effective drug for Alzheimer's disease, many industry talents have been attracted by the news and have come to invest.
At the same time, various countries also immediately announced the introduction of Sanqing AD specific drugs.
In terms of approval procedures, they are all passed as quickly as possible, striving to carry out clinical trials as soon as possible and speed up the marketing process.
Patients and their families in Western countries were relieved to learn that the new drug was finally about to begin Phase III clinical trials.
One after another, they went to relevant hospitals and clinical research institutions to register and apply.
After all, wasn't it that they had been making trouble for so long just to participate in clinical trials as soon as possible?
Now, patients can’t wait and are waiting for this new drug to save their lives.
