Takeda Pharmaceutical: Accelerating Global Drug Innovation with China Speed

With a 238-year history, Takeda Pharmaceutical Company Limited is one of the largest pharmaceutical companies globally. Over the past three to four years, Takeda has strategically transitioned from a traditional small-molecule drug company to a leader in next-generation innovative therapies that go beyond small molecules, through continuous innovation and strategic investments and acquisitions, thereby truly leading global innovation.

At a media briefing held at the Takeda Asia Development Center, VCBeat interviewed Andy Plump, Global Head of Research and Development at Takeda Pharmaceutical Company Limited, and Lin Wang, Head of the Takeda Asia Development Center. They shared insights into Takeda’s innovative R&D strategy, with a particular focus on achievements and plans for China and Asia.

In Takeda’s strategic layout, China has become one of the four key regions for its global R&D, alongside the United States, Japan, and Europe. Actively responding to favorable domestic policies, Takeda is accelerating the delivery of innovative medicines to more patients in China while further advancing toward synchronized global R&D.

In 1781, Takeda Pharmaceutical Company Limited was founded in Osaka, Japan. Its founder, Chobei Takeda, defined the company’s four core principles: integrity, fairness, honesty, and perseverance. In 2014, Christophe Weber, the current Global President and CEO of Takeda, joined the company and further articulated a modernized version of Takeda’s values—“P (Patient), T (Trust), R (Reputation), B (Business).” Centering on patients, building social trust, strengthening reputation, and growing the business have been Takeda’s enduring commitments and practices over the years.

Over the past four to five years, Takeda has continuously expanded its international footprint and business operations through acquisitions. Two developments are particularly noteworthy: first, the acquisition of ARIAD Pharmaceuticals, which enriched Takeda’s drug portfolio in the field of solid tumors; second, last year’s $62 billion acquisition of Shire, a leader in rare diseases, marking the largest acquisition ever by a Japanese company. Building on its already strong presence in the rare disease sector, Takeda has further solidified its unassailable position in this field.

Andy Plump, President of Global R&D at Takeda Pharmaceutical Company Limited

Andy Plump, President of Global R&D at Takeda Pharmaceutical Company Limited, emphasized that it was not through acquisitions but through transformative innovation that Takeda truly became a global leading biopharmaceutical company.

He mentioned that Takeda currently has three core business areas: innovative biopharmaceuticals, plasma-derived therapies, and vaccines. Eighty percent of Takeda’s R&D investment is concentrated in its innovative biopharmaceuticals business, with a focus on groundbreaking and curative therapies to address high unmet clinical needs and target highly specific patient populations. Oncology, rare diseases, neuroscience, and gastroenterology are the four therapeutic areas where Takeda focuses its R&D efforts.

As the world’s largest pharmaceutical company dedicated to rare disease research and development, 50% of Takeda’s R&D pipeline has received orphan drug designation. “In fact, approximately 75% of our R&D pipeline consists of orphan drugs; however, we have not yet submitted designation applications for some of them to the relevant authorities,” said Andy Plump.

Strategically, Takeda has improved overall efficiency by reducing investment in fixed infrastructure and fostering collaborations. Over the past four years, Takeda has continuously increased its innovation investments, with 60% allocated to external partnerships. “We choose to collaborate with innovative institutions to achieve optimal resource allocation, thereby maintaining the company’s agility and efficiency,” added Andy Plump.

Since 2015, Takeda has conducted more than 50 clinical trials in Asia (excluding Japan), with over 30 of them carried out in China. The company has collaborated with 366 clinical trial centers in China, aiming to accelerate the delivery of innovative medicines to Chinese patients.

In the coming years, Takeda expects to introduce more than 10 innovative medicines to China. Additionally, Takeda is actively expanding its portfolio in areas such as next-generation cell therapies for oncology, gene therapies for rare diseases and neuroscience, and other next-generation curative treatments.

Takeda’s Position in China Within Its Global Strategy Is Growing Takeda established its Singapore office as part of the Takeda Asia Development Center in 2009, and entered China by setting up a Shanghai office in 2012. The company is committed to further advancing and accelerating clinical development in China to meet the healthcare needs of patients in China and across Asia. Since 2015, Takeda has allocated special funds for five consecutive years to support new drug development in China, with the aim of bringing products already launched globally to the Chinese market as quickly as possible.

Leveraging favorable policies in China, Takeda is accelerating drug innovation in the country, with its Shanghai office now upgraded to serve as the headquarters of Takeda’s Asia Development Center. Since 2017, China has become one of the four key regions in Takeda’s global R&D network, alongside the United States, Japan, and Europe. “This means that for any of Takeda’s global projects, China must be included from the early development stages, ensuring synchronized development and new drug application submissions in China, the U.S., Japan, and Europe, so that Takeda’s innovative medicines can benefit Chinese patients at the earliest opportunity,” said Wang Lin.

Wang Lin, Head of Takeda Asia Development Center

Currently, among Takeda’s 40 clinical-stage pipeline products globally, 25 have China development plans, including six in oncology, six in gastroenterology, four in rare diseases, and nine in neuroscience, with the remaining programs also being accelerated.

“As a regional development center, one of our missions is to achieve synchronized development with global teams, bringing Takeda’s innovative drugs to patients in China and Asia as quickly as possible,” said Wang Lin. “Secondly, leveraging our geographical advantages in China and Asia, we are committed to amplifying the voices of Asian and Chinese patients on the global stage, ensuring that their needs are better addressed in global drug development.”

Wang Lin believes that for Takeda or rare disease patients, now may be the best time.

China released its first batch of 121 rare diseases last year, 18 of which have been included in the National Reimbursement Drug List. Additionally, the recently published “List of Clinically Urgent New Drugs Already Marketed Abroad” shows that rare disease treatments account for nearly half of the entries. The high domestic demand for rare disease medications presents a significant opportunity for Takeda Pharmaceutical Company Limited in the Chinese market.

On the first list of clinically urgent new drugs, there are three Takeda products: Entyvio (vedolizumab, for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis), Vpriv (for the treatment of Gaucher disease), and Firazyr (for the treatment of hereditary angioedema). Takeda has already submitted new drug approval applications for the first two products, while the submission for the third is in preparation. The second list includes Replagal, for the treatment of Fabry disease, for which a new drug application has also been submitted.

Takeda is also actively following up on certain innovative rare-disease drugs from the former Shire portfolio that have already been launched overseas; several new drug registration applications have been submitted, while others are still in preparation.

“Innovation alone is not enough; speed is also essential,” said Wang Lin. “Takeda aims to fully leverage China’s favorable policies, respond to the needs of patients and physicians, and accelerate the delivery of innovative medicines to more patients in China through proactive communication with regulatory authorities and close collaboration with CRO partners.”

Wang Lin shared three specific examples of how China’s new drug approval environment creates opportunities for accelerating Takeda’s innovation.

The first is NINLARO®, a proteasome inhibitor for the oral treatment of multiple myeloma, which was approved in China in 2018, only 2.5 years later than in the United States. It is the first drug in China to be approved based on domestic bridging studies. Furthermore, the overall survival data from China facilitated its approval in the European Union, as these were the first data to demonstrate that NINLARO® significantly improves patient survival.

The second example is TAK-788, a first-in-class product. It is a novel, potent, and selective small-molecule tyrosine kinase inhibitor targeting non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. At Takeda, this was also the first drug to undergo synchronized development in China and globally. China initiated patient enrollment for the ongoing pivotal study shortly after the United States, recruiting 30 Chinese patients within just three months. This enrollment rate far exceeded the global average, making China the first region to complete patient enrollment. In China, the incidence of this rare form of NSCLC associated with EGFR exon 20 insertions is several times higher than the global average. The case of TAK-788 demonstrates that China can play a leading role in global drug development in certain specific disease areas.

The third example is TAK-935, a drug for the treatment of developmental and epileptic encephalopathies (DEE), which is currently undergoing early Phase II clinical trials to verify its efficacy in specific patient populations from the perspective of its mechanism of action. This marks the first proof-of-concept trial with global participation that China has joined. To date, 27 patients in China have been enrolled in the clinical trial, ranking first globally in terms of enrollment numbers.

Wang Lin believes that a series of favorable policies introduced in China in recent years have transformed the country from a participant in global drug development into a contributor, and even a leader.

“Based on my more than 20 years of experience in the pharmaceutical industry, I have never seen any country drive health and healthcare at the national level like China, nor witness such rapid and substantial development in its innovation ecosystem, including in driving the research and development of products for rare diseases. It is truly remarkable,” said Andy Plump. “From a policy and regulatory perspective, we see that the adjustments China has made are driving innovation, and doing so very rapidly.”

“As Asia’s largest pharmaceutical company, we are committed to collaborating with the entire pharmaceutical innovation ecosystem to accelerate drug development in China and Asia, thereby contributing to global pharmaceutical innovation,” said Wang Lin.