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Recently, innovative drugs have gone overseas with good news
for a long time.
BeiGene announced that in a global Phase 3 clinical trial of the BTK inhibitor zebratinib (BRUKINSA) versus ibrutinib, zebratinib achieved progression-free survival (PFS) results in chronic lymphocytic leukemia/small lymphocytic lymphoma
indications.
On November 4, at the 2022 CIPEM Conference, Dr.
Wu Xiaobin, President, COO and General Manager of BeiGene China, delivered a speech
on "New Thinking on the Globalization of Innovative Drugs under the Great Changes Unprecedented in a Century".
When talking about the results of zebratinib, Wu Xiaobin couldn't hide his excitement: "We still have to believe that innovative drugs can go international, and now the overseas volume of zebratinib has exceeded that of China
.
" ”
Chinese innovative drugs should not only pursue First in class,
Chinese innovative drugs should not only pursue First in class,Me-better is just as important
Me-better is just as importantWhen analyzing the development path and status quo of innovative drugs in China, Wu Xiaobin first said that at present, the global research and development of innovative drugs is still concentrated in some popular targets, and the competition for some targets has become white-hot, including PD-L1, CD3, CD19, HER2, etc
.
Not only is the target competition intense, but innovative drug companies are also pursuing first-in-class, believing that micro-innovation is overdrawing industry resources
.
According to public information, innovative drugs have a variety of development modes, including me-too (drugs with the same target and similar mechanism of action as drugs that have been approved for marketing), me-better (drugs with advantages over marketed drugs) and first-in-class (drugs that have not yet been approved for any type of drug or have a new mechanism of action for the same target
).
However, Wu Xiaobin suggested that there is still a huge difference between our R&D capabilities and those of Western medicine, and we cannot blindly pursue to make big original drugs
in the absolute sense.
According to publicly available information,
Among the new drugs approved by the FDA in 2021, there are a total of 27 first-in-class drugs
.
in the absolute sense.
"The world's highest-selling drugs are not all first-in-class, first-in-class is not an absolute measure of the ability of innovative pharmaceutical companies, it also has the problem
of scope and safety.
" Wu Xiaobin said
.
Wu Xiaobin analyzed that the biggest benefit of China's innovative pharmaceutical companies is that the burden of patients is reduced and the population covered is increased
.
"On the one hand, the number of patients who can afford it will be greatly improved, and on the other hand, the irreplaceability of China's innovative drugs will also be enhanced
in the future.
" Wu Xiaobin said
.
Innovative medicines should also benefit developing countries
Innovative medicines should also benefit developing countriesIn recent years, China's innovative pharmaceutical companies have set sail, hoping to gain access in more countries through "going overseas" to achieve sales and market breakthroughs
.
In the case of BeiGene, according to its semi-annual report, BeiGene's BTK inhibitor BRUKINSA (zebratinib) has been approved for marketing in more than 50 countries and regions around the world, with global sales of 1.
514 billion yuan
.
Among them, BRUKINSA's sales in the United States increased by 504.
5% year-on-year to 1.
015 billion yuan
.
When talking about the overseas expansion of innovative drugs, Wu Xiaobin pointed out that innovative drug enterprises should be international, first, they can meet the unmet clinical needs of patients; Second, the foreign drug pricing system is different from China's, and innovative pharmaceutical companies can strive for more profits; Third, as far as the United States is concerned, its drug evaluation mechanism does not consider the price issue, as long as it can have better clinical results and meet a series of clinical trial requirements, it is highly likely to be approved
.
How to do a good job of innovative drugs going overseas? Wu Xiaobin made several suggestions, including building a localized business team and focusing on other developing markets
.
.
In terms of localized commercial teams, Wu Xiaobin revealed: "BeiGene's U.
S.
sales team is all local, and although the U.
S.
is a diverse society, drug sales require relationships, and this process of establishing diplomatic relations is more suitable for locals
.
”
Regarding the geographical selection of innovative drugs, Wu Xiaobin said that when innovative drugs go overseas, the United States and the European Union are associated with the United States and the European Union, which stems from the high profits and high returns
that their markets can provide.
At the same time, if it can be approved in European and American countries, it also means that the clinical efficacy of the drug has been verified
.
"However, it is the developing countries
that lack good medicines in the world more than developed countries.
How do we prove the value of innovative drugs in China? It is to repeat everything that has happened in China in the past ten years in other developing countries, so that most families do not need to smash pots and sell iron and sell houses to eat good medicine
.
Wu Xiaobin said
.
Taking PD-1 as an example, Wu Xiaobin mentioned that there are still large profit margins
for drug sales in other developing countries.
In China, a bottle is priced at 1,400 yuan, while Thailand is priced at 25,000 yuan, with a price difference of 17.
5 times, because Thailand has no local drug research and development capabilities, and can only rely on imports, which is an opportunity
for Chinese pharmaceutical companies.
