Takeda Oncology

# Decades of Leadership in Oncology



***- With Marketing Authorization Submissions in the U.S., European Union and Japan Planned in 2023, Fruquintinib Offers a Potential New Treatment Option for Patients with Refractory Metastatic Colorectal Cancer***

***- Licensing Agreement for Fruquintinib Strengthens Takeda’s Growing Oncology Portfolio***

**OSAKA, Japan and CAMBRIDGE, Massachusetts** – **January 23, 2023**  – Takeda [TSE:4502/NYSE:TAK](https://www.takeda.com/investors/) today announced that it has entered into an exclusive licensing agreement with HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) and its subsidiary HUTCHMED Limited, for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau.

Approved in China in 2018, fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. Fruquintinib is orally administered and has the potential to be used across subtypes of refractory metastatic colorectal cancer (CRC), regardless of biomarker status.

“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” said Teresa Bitetti, President of the Global Oncology Business Unit at Takeda. “We have a strong track record of working with companies that share our focus on bringing transformative medicines to patients around the globe who need them. Working with HUTCHMED will enable us to expand our oncology portfolio, bringing us one step closer to achieving our aspiration to cure cancer.”

Takeda is committed to oncology and developing new medicines for cancer patients who have limited or ineffective treatment options. With a strong preclinical and clinical profile, fruquintinib offers a potential new treatment option for patients with refractory metastatic CRC, supporting the shared goal of Takeda and HUTCHMED to improve the lives of those living with cancer worldwide.

“We are pleased to be partnering with a company that shares our mission to improve treatment outcomes for cancer patients and has the scale and expertise in global drug development and commercialization to advance fruquintinib globally outside of China,” said Dr. Weiguo Su, Executive Director, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “We believe that fruquintinib has a very strong future and look forward to working with Takeda to unlock its potential.”

Positive results of FRESCO-2, the Phase 3 multi-regional clinical trial of fruquintinib in refractory metastatic CRC were presented at the European Society for Medical Oncology (ESMO) Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival (OS) in patients with metastatic CRC and was generally well tolerated.

The U.S. Food and Drug Administration (FDA) granted Fast Track designation for the development of fruquintinib for the treatment of patients with metastatic CRC in 2020. In December 2022, HUTCHMED initiated a rolling submission of a New Drug Application (NDA) for fruquintinib with the U.S. FDA, which is planned to be completed in the first half of 2023. This will be followed by planned submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a JNDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).

Under the terms of the agreement, Takeda will receive an exclusive worldwide license to develop and commercialize fruquintinib in all indications and territories outside of mainland China, Hong Kong and Macau. Subject to the terms of the agreement, Takeda will pay HUTCHMED $400 million upfront, up to $730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales. The deal is subject to customary closing conditions, including completion of antitrust reviews.

## About CRC

CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020. In the U.S., an estimated 155,000 patients were diagnosed with CRC and there were 54,000 deaths from the disease. In Europe, CRC was the second most common cancer in 2020 with approximately 520,000 new cases and 245,000 deaths. In Japan, CRC is the most common cancer with an estimated 148,000 new cases and 60,000 deaths in 2020. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options.

## About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, 2 and 3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.

## About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited ([**TSE: 4502/NYSE: TAK**](https://www.takeda.com/investors/ ) is a global, values-based, R\&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R\&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R\&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R\&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit  [**https://www.takeda.com**](https://www.takeda.com).

For more information, visit  [www.takedaoncology.com](https://www.takedaoncology.com/).

### Media Contacts:

**Japanese Media**\
Jun Saito\
<jun.saito@takeda.com>\
\+81 (0) 3-3278-2325

**Media Outside Japan**\
Carrie Fernandez\
<Carrie.Fernandez@Takeda.com>\
(215) 859-2605

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at:  [https://www.takeda.com/investors/sec-filings/](https://www.takeda.com/investors/sec-filings/)  or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.


Takeda To Acquire Exclusive Worldwide (ex-China) License of HUTCHMED’s Fruquintinib, a Highly Selective, Oral VEGFR1/2/3 Tyrosine Kinase Inhibitor

Takeda’s EXKIVITY® (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC

Demonstrating Commitment to Patients with Hematologic Cancers and Other Blood Diseases, Takeda today announced that it will present 15 company-sponsored abstracts at the 64th American Society of Hematology (ASH) Annual Meeting being held December 10-13, 2022 in New Orleans. 

Takeda to Present Data at 64th American Society of Hematology (ASH) Annual Meeting, Demonstrating Commitment to Patients with Hematologic Cancers and Other Blood Diseases

Phase 3 Trial of ICLUSIG® ponatinib Met Primary Efficacy Endpoint in Frontline Ph+ ALL Where No Other Targeted Treatments are Currently Approved in the US

Phase 3 Trial of ICLUSIG® (ponatinib) Met Primary Efficacy Endpoint in Frontline Ph+ ALL Where No Other Targeted Treatments are Currently Approved in the US

## Oncology News



# Oncology Pipeline&#xA;

Discovering and developing innovative therapies to deliver potentially transformative treatments


Science

/science/

Medicines

/medicines/

Patients

/patients/

Investors

https://www.takeda.com/investors/

Partnerships

/partnerships/

Oncology Careers

/about/careers/

## About Takeda Oncology



# Divider Section

*This piece of sponsored content was produced by Re:think, the content marketing studio at The Atlantic. This article was originally published on* [*Atlantic Re:think*](https://www.theatlantic.com/sponsored/takeda-2022/can-we-cure-cancer-with-data/3779/)*.*

**Can We Cure Cancer with Data?**

Founded in the 18th  century as a traditional herbal medicine store in Osaka, Japan, Takeda has upheld a commitment to quality and innovation throughout its 240-year history. Today, as a global pharmaceutical company and a longtime innovator in the cancer research and treatment space, the organization is giving its Oncology Business Unit a dramatic data and digital transformation to better serve its patients at every step of their treatment journey. We spoke with Samer Ansari, the unit’s head of data, digital and technology, about why data and emerging technologies are critical to the discovery and development of new cancer treatments, and to the experience of patients and families suffering from these diseases.

**Atlantic Re:think:**  **Takeda’s Oncology Business Unit is unique in both structure and approach. Could you describe its mission and how emerging technology can play a role in achieving it?**

**Samer Ansari:**  Our business unit operates like a nimble biotech within a big pharmaceutical company, and it allows us to be very agile. That license to move with agility is fundamental because we are on a mission to cure cancer and must work with a sense of urgency—at the end of everything we do, there are patients waiting for innovative medicine to reach them as fast as possible. We are building industry-leading data and digital technologies that are helping us deliver on this commitment, enabling us to move at speed in our research and development and in our ability to reach people living with cancer.

**Atlantic Re:think:**  **What role do data and analytics play in cancer research and treatment?**

**Samer Ansari:**  Humans can only do so much in a small amount of time, and AI and machine learning are the augmenting factors that multiply what a human can achieve, ultimately creating greater efficiency and accuracy. The analogy I always think about is car racing. You can have the best car, but if the driver is not skilled enough to make those tight turns at the right time, the car alone cannot win the race. We have smart humans; we’ve cracked that. Now we’re empowering them with advanced data and technology capabilities to make sure that we can win the race for our patients.

Let me give you an example: A key objective for us is to make sure that our clinical trials are inclusive and diverse, and we’re trying to connect the right patient with the right trial at the right time, anywhere in the world. Data and digital technologies are a key accelerator here as we can model large and complex data sets on a frequent basis, predicting where trial-eligible patients may be and which clinical trial sites can meet trial-specific diversity goals. This then helps us connect with the right people and sites through digital channels to ensure timely engagements.

**Atlantic Re:think:**  **What kind of organizations do you work with, and what is the nature of these partnerships? Why are these strategic partnerships important in the effort to treat, and ultimately cure, cancer?**

**Samer Ansari:**  Curing cancer is not something we can do alone. We’ve curated tremendous partnerships with leading pharmaceutical companies, health-care providers, diagnostic companies, hospital centers, community centers, academia and even the tech industry. In fact, I find that Takeda Oncology is increasingly reliant on digital innovation from outside of the health-care industry to aid in accelerating our efforts to discover, develop and deliver life-transforming cancer treatments. What these diverse partnerships have in common is that we share similar values and aim to create better experiences and outcomes for people living with cancer.

**Atlantic Re:think:**  **How does the era of hybrid physical-digital experience apply to cancer and oncology?**

**Samer Ansari:**  When it comes to early diagnosis of cancer, hybrid digital innovation can play a huge role. During the coronavirus pandemic, it was really heartbreaking to see that in-person diagnostics were delayed, and health-care professionals were finding out about patients’ illness much later in their cancer stage. Smart, small, nimble technology in people’s homes could provide early indicators through real-time data analytics to detect cancer in its earliest stages. It’s a huge unmet need and an even bigger opportunity to reshape the way we think about digital technology and the application of data. The industry has a long way to go in creating that holistic experience that is outcome-driven and value-based, and enables the patient to orchestrate a more personalized experience instead of making them undergo a standard experience from our company. I am proud of the fact that Takeda is already making progress with this mindset.

**Atlantic Re:think:**  **What are some of the challenges of working with new innovative forms of technology in the pharmaceutical industry?**

**Samer Ansari:**  All of us are on a learning journey to discover the ways in which unleashing the power of data and digital can impact how we work and what we can accomplish, including Takeda Oncology. I think companies that realize digital transformation isn’t a one-and-done shift, but a fast-evolving cultural change driven by innovative mindset, will be among the first to see improved performance and competitive positioning in their efforts to best serve people throughout their health-care journey. It is also extremely important to keep ethics and trust embedded in all our innovations, and that sense of responsibility is key.

**Atlantic Re:think:**  **What are the gaps in the current applications of technology that, once filled, could improve the cancer research and treatment experience?**

**Samer Ansari:**  Currently, early diagnosis and side-effect management is critical for the person living with cancer and for their caregiver. By monitoring the patient’s ongoing health progress on a real-time basis, we have access to more information that can help us, and their health-care providers, make better outcomes. The sooner we know, the more we know and the more we can help—that’s where there’s huge potential.


Atlantic Re:think Q&A with Samer Ansari, Takeda’s Oncology Business Unit Head of Data, Digital & Technology

Transforming Cancer Care Through Patient-Centric Partnership

The unspoken struggle of many people living with cancer lies in the financial burdens they face and the tough choices they must make for themselves and their loved ones as a result. Financial toxicity &ndash; the adverse financial effects of a cancer diagnosis &ndash; extends well beyond medical costs and is inclusive of daily living expenses including housing, transportation and food. How can the oncology community come together to address a health inequity this vast and complex for patients worldwide?

During a fireside chat for&nbsp;*The Atlantic, Takeda Oncology&rsquo;s Dion Warren, Vice President, Head, U.S. Oncology Business Unit, met with Carla Tardif, CEO of Family Reach, to answer this important question and discuss how partnerships can play a key role in addressing financial disparities among people living with cancer.*

___

&nbsp;

The unspoken struggle of many people living with cancer lies in the financial burdens they face and the tough choices they must make for themselves and their loved ones as a result.

Financial Toxicity: A Debilitating Side Effect of Cancer Care

![](https://res.cloudinary.com/takeda/image/upload/v1670825708/Takeda%2BOncology/siteassets/news/our-viewpoints/to-cure-cancer-let-scientific-discovery-grow/Teresa_Byline_Science_Growth.png)&ldquo;Plants grow better when they&rsquo;ve been repotted.&rdquo; This was one of my father&rsquo;s favorite sayings. And advice I heeded when I joined Takeda after many years of working at the same company. Ultimately, I knew that if I wanted to continue to grow and thrive, I needed to move and try something different.

I often reflect on my father&rsquo;s advice, and the power of this metaphor, when I think about our approach to growing our pipeline and fostering innovation at Takeda.

## **Planting the seeds of science**

Takeda has a long-rooted history of scientific discovery aimed at transforming the patient experience going back to 1781, when our founder, Chobei I, first began selling traditional herbal medicines. Over time, enduring scientific curiosity and commitment to patients became rooted in Takeda&rsquo;s values.

Today, these values guide our oncology pipeline strategy, focused on leveraging the power of innate immunity. Our innovative strategy is designed for a new era of oncology research &ndash; one we believe may hold the key to outsmarting cancer&rsquo;s evasion abilities through cutting-edge science leveraging the power of innate immunity.&nbsp;

Our immune system is comprised of the innate immune system and the adaptive immune system. Currently approved immunotherapies primarily target adaptive immunity (which includes T cells) rather than innate immunity (which includes powerful &lsquo;first responder&rsquo; cells, including natural killer cells).&nbsp;

New studies indicate the potential to broaden the impact of immunotherapy treatments by activating these two interdependent parts of the immune system to work together to achieve immediate (innate) and specific (adaptive) responses to threats, including cancers.&sup1;<sup>-</sup>&sup2; Our goal is to harness the power of innate immunity to introduce new classes of immunotherapies that can lead to deep, durable responses and bring the potential of immunotherapy to more cancer patients.

## **Cultivating our ecosystem**

We say we welcome innovation from everywhere, and we mean it. We&rsquo;re eager for insight and contributions from experts &ndash; internal or external &ndash; who share our vision and aspiration to cure cancer. Our philosophy that &ldquo;science is smarter&rdquo; is behind the cross-pollination of knowledge in our teams. From our clinical scientists to our regulatory managers, we combine the power of diverse and experienced scientific minds to deliver our best and develop medicines with curative intent.

We also draw and build upon the expertise and experience of medical professionals, industry colleagues, advocates, academia, government, policymakers, payers and others. Scientific partnerships inform our clinical development approach and foster shared knowledge and insight to find the best way to attack cancer. Our scientific collaborations are making an impact &ndash; as is our collaboration with patient groups who share our conviction to create a world where[ all patients](https://www.takedaoncology.com/patients/patient-advocacy/) have access to the treatment *and the support they need in their battle against cancer. &nbsp;&nbsp;*

To grow, it is important to have the right conditions. To bloom, continued care and encouragement are essential. And to thrive, we must be open to exploring new ground. In our battle against cancer, it is with this mindset that we approach new challenges, and know that with each day, and each development, we are moving closer to our goal.

*To learn more about leadership within Takeda Oncology and our growing pipeline, catch Teresa&rsquo;s[ **interview**](https://www.pharmavoice.com/news/woman-of-the-week-takeda-oncologys-teresa-bitetti/629823/) with the PharmaVoice Woman of the Week podcast.*

*For more information about how we are exploring the untapped potential of the innate immune system, please visit[ **Our Approach to Harnessing Innate Immunity**](https://www.takedaoncology.com/science-research/innate-immunity/). &nbsp;&nbsp;*

*&nbsp;*

*&nbsp;*

*References*

&sup1; *Chang RB, Beatty GL. The interplay between innate and adaptive immunity in cancer shapes the productivity of cancer immunosurveillance. J Leukoc Biol. 2020;108(1):363-376. doi:10.1002/JLB.3MIR0320-475R &nbsp;*

&sup2; *Hartl CA, Bertschi A, Puerto RB, et al. Combination therapy targeting both innate and adaptive immunity improves survival in a pre-clinical model of ovarian cancer. J Immunother Cancer. 2019;7(1):199. Published 2019 Jul 30. doi:10.1186/s40425-019-0654-5*

"Plants grow better when they've been repotted." I often reflect on the power of this metaphor when I think about our approach to growing our pipeline and fostering innovation at Takeda.

To Cure Cancer, Let Scientific Discovery Grow

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