Reporter Zhang Xue.
On December 12, Baili Tianheng announced that it would license the global rights and interests of the new EGFR HER3 ADC drug BL-B01D1 outside China to Bristol-Myers Squibb (BMS), which became the first new bispecific antibody ADC drug successfully launched in China. The down payment of US$800 million and the potential total transaction amount of US$8.4 billion have both broken the record of a single project of domestic innovative drugs going overseas, once again proving that the R&D strength of domestic innovative drugs has been at the forefront of the world.
In 2023, known as the "first year" of Chinese pharmaceutical companies going overseas, the number of license-out (overseas authorization) of Chinese local pharmaceutical companies exceeded that of license-in (license introduction) for the first time, the scale of foreign licensing cooperation has repeatedly hit new highs, and a number of domestic innovative drugs have successfully entered the European and American markets and been approved for marketing.
The transaction between Baili Tianheng and BMS has once again ignited the market's confidence in the investment in the field of domestic innovative drugs. Industry insiders believe that the fact that these products and pipelines can go overseas is the result of the accumulation of the past 5 to 10 years, which represents that China's local innovation has changed from quantitative to qualitative.
The speed of domestic innovative drugs going overseas has been accelerated
According to the announcement, Baili Tianheng and BMS will share the global development expenses of BL-B01D1, as well as the profits and losses in the US market, and BMS will receive a sales share in the Chinese market, and outside the United States and China, Baili Tianheng will receive a sales share of BMS.
Under the terms of the agreement, BMS will make an upfront payment of US$800 million, near-term contingent payments of up to US$500 million, and milestone payments of up to US$7.1 billion, for a potential total transaction value of up to US$8.4 billion, to Systimmune, a wholly owned subsidiary of Baili Tianheng. Among them, the down payment of US$800 million and the potential total transaction amount of US$8.4 billion have both set a record for a single project of domestic innovative drugs to go overseas.
With the continuous development of domestic innovative drugs, China's pharmaceutical innovation has ranked among the forefront of global R&D, and innovative drugs and R&D technology platforms have gradually been recognized globallyAt the same time, the global financing environment for innovative drugs will improve in 2023, supply and demand will usher in a two-way rush, and the speed of domestic innovative drugs "borrowing ships to go to sea" will accelerate.
According to incomplete statistics from a reporter from Shanghai ** Daily, in the fourth quarter of this year alone, there were more than 15 overseas authorization projects in China, involving Hengrui Pharmaceutical, Henlius, Legend Biotech and Hansoh Pharmaceutical. Among them, Hengrui Pharmaceutical has the largest number of transactions, accounting for 3. There is also no shortage of blockbuster deals of more than $1 billion.
What's even more gratifying is that with the continuous advancement of the research and development of innovative drugs, in addition to "borrowing ships to go to sea", cases of "going to sea independently" are also emerging, and a number of new drugs have successfully entered the European and American markets and been approved for marketing this year.
In just over a month and a half, Bio-Thera's biosimilar bevacizumab injection (BAT1706) has received marketing approval from the FDA (Food and Drug Administration), becoming the company's second product to receive FDA marketing approval after tocilizumabJunshi Biosciences announced that the Therapeutic Products Administration (TGA) of Australia has accepted the marketing authorization application for its anti-tumor immune** PD-1 inhibitor toripalimab, which has been approved by the FDA, making it the first Chinese anti-PD-1 monoclonal antibody to be approved by the FDA. Yifan Pharmaceutical's third-generation leukocyte growth factor iberistim injection was approved by the FDA for marketing. Chi-Med's in-house developed oncology drug fruquintinib received FDA approval, making it the first and only highly selective inhibitor of all three anti-vascular endothelial growth factor (VEGF) receptors in the U.S. for the treatment of metastatic colorectal cancer.
From the perspective of drug types, with the improvement of the independent research and development capabilities of Chinese pharmaceutical companies, overseas drugs are no longer dominated by small molecule chemical drugs and antibody drugs, and bispecific antibody drugs and antibody drug conjugates with stronger targeting and more effective efficacy have increased their overseas sales, and domestic innovative drugs have gradually won a place on the world stage with a new generation of biotechnology.
Differentiating clinical value gains pricing power
In the industry, there is a saying: "If you don't go to sea, you're out." ”
On the one hand, the domestic centralized procurement policy and the national medical insurance negotiation have brought downward pressure on drug pricesOn the other hand, innovative drugs have a long cycle and large investment. Affected by this, the pressure on innovative pharmaceutical companies to recover their investment and even obtain profits is increasing, and it is urgent to break the situation. In this regard, the consensus of the heads of many innovative pharmaceutical companies interviewed is: "The research and development of new drugs must be global, and truly innovative drugs should pursue global effects." This means that for all companies that really make innovative drugs, going overseas is not an option, but a must.
Living up to expectations, overseas markets have indeed given more "premiums" to China's innovative drugs, which is not only related to the financing and payment ability of local medical insurance, but also has a close impact on the excellent product strength of the product itself in terms of unmet clinical needs.
As a pioneer in the U.S. innovative drug market, BeiGene's zanubrutinib has gained more pricing power based on the "head-to-head" clinical data of the Phase III clinical trial. According to a research report by Pacific**, BeiGene's zanubrutinib is sold at 17 times the price in overseas markets.
Recently, Takeda Pharmaceutical's official website announced that fruquintinib**, in collaboration with Chi-Med, is US$25,200 (5mg*21 capsules) (approximately RMB180,000), which is almost 24 times the domestic price. Junshi's partner Coherus also announced the price of PD-1 toripalimab in the United States, 889203 US dollar bottle, equivalent to more than 60,000 yuan, is more than 30 times the domestic price. Legend Biotech's BCMA Car-T** cilta-cel sales performance is also impressive. In the U.S. market, cilta-cel is priced second only to Kymriah, the world's first marketed product, at more than $460,000.
The higher ** has increased profits, and also encouraged pharmaceutical companies to further increase innovation, so as to create innovative drugs with truly differentiated clinical value.
The U.S. isn't the only destination. According to public data, China's largest export of pharmaceutical products to the "Belt and Road" countries is ASEAN, and the export volume has increased by 1 in the past 10 years8 times. At the same time, the export volume of China's pharmaceutical products to Latin American countries has also exceeded 10 billion US dollars. This year, the Middle East, North Africa and other places have also become important destinations for China's innovative drugs to go overseas.
In October, Hengrui announced that it had reached an agreement with Dr. Reddy's Laboratories, an Indian pharmaceutical company, to transfer the rights to develop and commercialize the self-developed small molecule targeted drug pyrotinib maleate tablets in IndiaIn September, BeiGene's PD-1 tislelizumab was approved for the first indication in the European Union, becoming the first domestic PD-1 to go overseas in EuropeIn March, Junshi Biosciences officially announced that it will establish a joint venture with Kanglianda Biotech to cooperate in the development and commercialization of PD-1 toripalimab in Southeast Asia.
How high can the rise of China's innovative drugs go in the future?How many legends will be created?We look forward to it even more.