«From a commercial perspective, the six late-stage projects in our R&D pipeline are expected to achieve peak sales of USD 10 to 20 billion, with oveporexton leading the charge».

Andy Plump, Global President of R&D at Takeda, revealed this in a recent media interview. The orexin receptor 2- (OX2R) targeted drug he referred to recently took the spotlight at the 2025 World Sleep Congress (WSC) — with impressive global Phase III clinical data, this first-in-class (FIC) drug targeting the root cause of type 1 narcolepsy is expected to fundamentally change the treatment landscape, benefiting patients worldwide.
Just as the industry questioned Takeda's development prospects after its R&D pipeline adjustment, the company gave a forceful reply with oveporexton's progress as part of a group of six late-stage projects the company is moving to Phase III clinical trials for multiple indications, all of which will yield results over the next three years.
Facts prove that thanks to Takeda's focus on its core therapeutic areas coupled with a flexible R&D strategy (and despite ongoing pipeline adjustments) Takeda's product pipeline remains highly competitive, with Chinese innovation playing a key role.
Recently, PharmCube interviewed Andy Plump himself and Lin Wang, Takeda's R&D head for China and Asia Pacific, who revealed new highlights of the firms's key late-stage projects, the opportunities brought by external innovation, as well as Takeda's R&D strategy in view of the continuous development of Chinese innovative drugs in recent years.

Potential FIC Leads the Way as Takeda's Late-Stage Pipeline Gains Momentum

In Plump's view, oveporexton's journey — from R&D stage to showing efficacy in type 1 narcolepsy patients — is an excellent demonstration of Takeda's innovation capabilities.

«Drugs that demonstrate oveporexton's level of efficacy are very rare, especially for targets within the brain. We have uncovered a completely new pathway, and the results achieved are groundbreaking. It is pioneering a new standard of care and a new treatment field for narcolepsy patients». When discussing the drug's value today, Plump and Wang still cannot conceal their excitement.

According to results of the two clinical studies disclosed by Takeda, both the FirstLight (TAK 861 3001) and RadiantLight (TAK 861 3002) studies met all primary and secondary endpoints. Compared to placebo, a broad range of symptoms in type 1 narcolepsy showed statistically significant improvement. At week 12, all dose groups (1 mg twice daily and 2 mg twice daily) had P-values <0.001. To date, the candidate has been generally well tolerated, with a consistent safety profile across clinical studies.

This is undoubtedly one of the most exciting datasets presented at WSC. Plump also believes this product is exceptionally significant: «Oveporexton is the first drug to truly target the root cause of the disease; for many symptoms, this drug can truly allow patients to return to normal and live their lives like ordinary people again».

But the treatment's impressive efficacy is no accident. The molecule was initially discovered by Takeda at its Shonan research centre laboratory in Japan. According to Plump, to develop oveporexton, Takeda assembled its largest ever team of scientists for long-term research investment. The motivation for this endeavour is that for type 1 narcolepsy — a chronic, rare neurological disorder — existing therapies can only improve some symptoms.

It is worth mentioning that oveporexton's clinical achievements also relied on China's large patient population and research infrastructure. As head of Takeda R&D for China and Asia Pacific, Wang feels deeply about this: «China participated not only in the late-stage study but also in the Phase I trial. This allowed us to better understand how to conduct narcolepsy clinical trials in China and engage [Chinese] research institutions and doctors. These all contributed to the global data».

But this is only the beginning. With oveporexton leading the way, Takeda also sees significant opportunities to extend orexin biology beyond type 1 narcolepsy to other diseases.

Currently, Takeda has a second molecule, TAK 360 (an oral OX2R agonist), under development for type 2 narcolepsy and idiopathic hypersomnia. A third molecule will also enter the clinic later this year to explore potential indications in more common diseases. Furthermore, other key late-stage projects are about to see new progress, including Phase III data for psoriasis drug zasocitinib expected this year.

«Continuously challenging ourselves and optimising priorities is one of our key principles», explained Plump. Takeda's proactive decisions on early-stage projects and focus on advancing the late-stage pipeline embody this principle: «The investment scale in Phase III projects evinces the maturity and success of the pipeline».

Leveraging Chinese Innovation to Accelerate Global R&D

Takeda's ability to build this promising product pipeline is also supported by its open and flexible R&D foundation. Over 30 years of industry dedication and deep understanding of global markets have made Plump realise that achieving sustainable innovation ultimately requires not working behind closed doors but «both having excellent internal innovation and embracing external innovation».
«Although we have excellent scientists and laboratories, Takeda's own capabilities represent only a small fraction of global pharmaceutical innovation. Research estimates that about 75% of drugs initially originate from academic institutions and biotech companies», Plump further pointed out, emphasising that Takeda places great importance on collaboration globally.
To date, Takeda has over 135 ongoing collaborations. According to Wang, more than 40% of Takeda's global product portfolio comes from collaborative projects. In recent years, the burgeoning Chinese innovation has gradually become key for Takeda's strategic focus.
In 2022, after Takeda established its Asia Pacific R&D headquarters in Shanghai, it took on the mission of bringing Chinese innovation to the global stage.
To achieve this, on one hand, Takeda is conducting more early-stage research in China, oveporexton being an excellent example. «China's vast patient pool and significant unmet needs show us greater potential. We recognise that China can not only accelerate local R&D but also global R&D», said Wang. On the other hand, «we also hope Chinese innovation can integrate into Takeda's overall R&D strategy», creating a win-win situation.
PharmCube's NextBiopharm® database shows that since 2018, with the rapid development of China's innovative drug industry, pharmaceutical transactions involving Chinese companies have significantly increased. Over the past decade, there have been 1,077 out-licensing deals and 1,412 in-licensing deals, making China the second-largest participant in global pharmaceutical transactions. In recent years, the number of out-licensing deals from Chinese companies has increased substantially, with 22 in 2024 alone, accounting for 32% of global total. These transactions primarily focus on highly innovative drugs with R&D progress ranking in the global top five.

A previous Stifel Research report indicated that in 2024, over 33% of assets in-licensed by large pharmaceutical companies came from China. It can be said that Chinese innovation is becoming a preferred choice for MNCs to enhance their pipeline strength.

As an active participant in this trend, Takeda clearly has a more defined understanding of innovation. In Plump's view, innovation is not merely about discovering new targets; there exists vast potential for innovation within existing fields as well. True innovation is what can genuinely change patient treatment outcomes. This is Takeda's primary principle in external collaborations.

In 2023, Takeda secured the overseas rights authorization for HUTCHMED's fruquintinib, which best exemplifies this principle. Although fruquintinib targets an established target as opposed to a novel one, it achieved best-in-class status. Plump stated that in the first two years since its overseas launch, fruquintinib's sales were three to five times the initial projections.

At the end of last year, Takeda's China and Asia Pacific R&D headquarters and the ATLATL Innovation Center established a joint laboratory through an innovative collaboration model, dedicated to translating clinically identified targets or ideas into actual drug development. In Wang's view, this is a typical example of Takeda's collaboration with China's innovation ecosystem. In the future, «through ATLATL, Takeda will further expand connections with a broader ecosystem in China», she said.
In recent years, Takeda's accelerated efforts in the Chinese market are precisely due to its high regard for China's innovative capabilities.
In fact, after a decade of evolution, China's innovative drug industry has presented an entirely new landscape, its engineering capability, efficiency and innovation all leaving a deep impression on Plump. «These three elements combined together constitute China's unique ecosystem. I believe that in the next five years, China will become a major force in global R&D, much like Boston».
With the continuous evolution and leap of China's innovation capabilities, Wang emphasised, «In the past two to three years, China has produced many best-in-class and potential first-in-class innovations. Even in Takeda's collaborations with top Shanghai hospitals, we have seen targets with first-in-class potential».
According to her: «Now researchers can work closely with doctors and hospitals. Doctors identify new targets for certain diseases and can quickly relay feedback to researchers. This cycle is closed and highly efficient». Clearly, China's innovative drug ecosystem, having achieved a closed loop of innovation, is fostering more original innovations. For instance, in Takeda's key focus areas — oncology, gastroenterology & immunology, and neuroscience — oncology and immunology are witnessing significant breakthroughs in China.

Internal and External Excellence to Maintain a Competitive Advantage

Currently, by embracing external innovation, Takeda's R&D pipeline has been continuously strengthened. Its simultaneous self-renewal efforts synergise with external innovation, collectively reflecting Takeda's persistent pursuit of more efficient research capabilities.
Over the past decade, Takeda's R&D strategy has undergone multiple upgrades and iterations — from initially focusing solely on small-molecule drugs to today's precision strategy centred around four core technologies. Each adjustment has been made in response to industry trends and kept pace with the times. As the helm of Takeda's R&D, Plump, who joined Takeda in 2015, has deep feelings about this.
Regarding the current strategy, he summarised: «First, we must delve into the mechanisms most likely to meet patient needs. Second, we must accelerate speed, balancing efficacy and efficiency. Additionally, we must dare to stop projects — a well-considered and swift decision is better than prolonged indecision».
In its Q4 2024 financial report, Takeda disclosed a significant trimming down of its pipeline. The outcome of this overhaul in the clinical pipeline was opposite to what the outside world feared — not only was there no innovation continuity issue, but the late-stage pipeline demonstrated robust potential. As Plump previously stated, Takeda's R&D philosophy has shifted from «pursuing all possibilities» to «deeply empowering the core».
Under such a focused strategy, deep integration of new technologies like AI and digitalisation has become a key enabler and core competitive advantage for Takeda. In Plump's view, every company will use new technologies in the future; the difference lies in who can quickly embrace and proficiently apply them. Therefore, over the past few years, Takeda has pursued excellence both internally and externally — building and maintaining proprietary technologies internally while openly seeking digital collaborations externally.
Confidence in new technologies and the implementation of an open strategy have positioned Takeda among the first pharmas to initiate their digital transformation. Plump revealed: «In the next one to three years, all Takeda R&D projects will be empowered by digitalisation and AI. We are reshaping the entire approach to drug discovery, with digitalisation as the starting point and foundation».
China's prominent advantages in technologies such as AI and digitalisation also provide significant potential to empower Takeda's global R&D. In fact, Chinese innovation has become a new development opportunity that pharmaceutical giants cannot ignore today. «Thanks to advantages in R&D quality and efficiency, we hope to further deepen our R&D strategy in China», Wang stated firmly.
As Takeda continues to implement its focus on core and open innovation strategy and increasingly invests in the Chinese market, it is not difficult to believe that after oveporexton, it will also introduce more blockbuster products, empowered by China's innovation ecosystem while contributing its solutions to the global healthcare field.