Investor Relations

Pharmaceuticals Business

Kazuto Koizumi Member of the Board Managing Director
Head of Pharmaceuticals Group

Business Vision

We contribute to society through improved patient outcomes achieved as a result of innovation using our technological expertise, the stable supply of high-quality pharmaceuticals, and the provision of information.

Mid-term Business Strategy

Continue to grow with Speciality,
Biosimilar and Generic pharmaceuticals as our core areas.

Business Profile

The pharmaceuticals business has expanded operations by focusing on anti-cancer drugs and cancer-related agents since the launch of BLEO® in 1969. We have the largest lineup of cancer related products, including generic drugs, among Japanese pharmaceutical companies, and we are providing these products as well as highly reliable information on the cancer field to medical institutions. While moving forward with development of polymeric micelle anti-cancer drugs, which utilize nanotechnology, we have also been promptly working on the development of biosimilars. As early as 2014, we launched Japan’s first monoclonal antibody biosimilar. Through these activities, we are contributing to society by realizing improvements in patient outcomes and more efficient medical spending.

Pharmaceuticals Business

Mid- and Long-term Outlook for the Business

In the field of cancer treatment, our goal is to provide a stable supply of high-quality, affordable generic drugs and biosimilars, which will allow us to contribute to society by improving the efficiency of healthcare spending. That said, sales and profit of pharmaceuticals in Japan are expected to be significantly affected by the annual drug price revisions, and competition among companies is intensifying as well. A key challenge for our pharmaceuticals business is to continually bring to market new products in the areas where we are strongest, and which our competitors cannot provide. To that end, one of our goals is to help improve medical care by meeting a variety of medical needs, including researching and developing new anti-cancer drugs such as polymeric micelle anti-cancer drugs, improving the efficacy and reducing side effects of existing drugs, and more. We are furthermore aiming to build up our pipeline and grow our pharmaceuticals business over the medium to long term by exploring product introductions and licensing opportunities through cooperation with other companies.

Initiatives under Mid-term Business Plan “KAYAKU Next Stage

The fiscal year ended March 2020 saw the launch of PORTRAZZA®, a new biomedicine for treating squamous cell non-small cell lung cancer. We also signed a co-promotion agreement with Bayer for NUBEQA® tabs, a medicine used to treat prostate cancer. One of the key focus areas for this second year of “KAYAKU Next Stage” is to promote the specific benefits of these drugs and use them to provide new types of treatment for patients.
 The sales of biosimilars are increasing as the next growth field after generic drugs. We are therefore aiming to further expand the sales of biosimilars, and collect and provide more information in this field than ever before. Meanwhile, in terms of advancing MR activities during the “new lifestyle” brought about by the pandemic, constructing a system which can handle remote sales has become an urgent issue.
 In the area of R&D, we are promoting research for creating new products from a long-term perspective. In the field of generic anti-cancer drugs, we are responding to needs in medical settings by taking on the challenge of developing the drugs in highly-complex and devised dosage forms. We will furthermore proactively create alliances to enhance our product lineup.
 The stable supply of pharmaceuticals has become a concern, as factors such as regional conflicts abroad and the spread of the novel coronavirus threaten to stabilize supplies of raw materials and other items. It is essential that we build a solid supply chain and establish a comprehensive system to ensure products can be delivered in a stable manner.
 Furthermore, as a pharmaceutical company, it is our mission to supply products that meet all regulations and provide a high level of quality. The entire business group is committed to working together to provide safety and peace of mind to our customers.

Key Themes in Mid-term Business Plan

Theme Details of initiatives
Establishing safety and quality management systems
  • Always keep in mind the risks during operations and inspections Prevent reoccurrence and spread knowledge laterally by thoroughly investigating the causes of problems
Strengthening research and development
  • Pharmaceuticals Group unites to create new products that match medical needs in our areas of technical expertise and fields of specialty
Creating and providing intellectual added value
  • Create systems that enable the continuous introduction of new products to the market
Strengthening the business through internal and external partnerships
  • Expand pipeline by pursuing synergy in product launches, engaging in business alliances, and conducting M&A
  • Expand export and contracted production business for the Specialty Chemicals, International & IVD Division
Building a strong business base capable of supporting growth
  • Practice compliance and adhere to regulations to improve our presence as a company contributing to cancer treatment and to distinguish ourselves from our competitors.
  • Use management resources effectively to create a corporate structure capable of adapting to changes in the pharmaceutical industry
  • Promote the transfer of technology and knowledge, and foster the development of the next generation of human resources to strengthen our R&D, manufacturing, and sales structures

Topics

The pharmaceuticals business of the Nippon Kayaku Group focuses on “specialty drugs, biosimilars and generic drugs.” For the assurance of using we have established a reliable structure centered on enhancements to our anti-cancer drug and cancer-related medicine product lineup and the stable supply of such, together the provision of information on the proper use of such by MRs specializing in cancer treatments who possess an extensive knowledge of anti-cancer pharmacotherapy.

Launch of new biopharmaceutical Portrazza®

In November 2019, we launched the anti-cancer drug and anti-EGFR (epidermal growth factor receptor) human monoclonal antibody "Portrazza® Intravenous Infusion 800 mg." Eli Lilly and Company has been marketing this drug in Europe and the United States since 2015 as a treatment for advanced and recurrent squamous non-small cell lung cancer, and since we acquired its manufacturing and marketing rights in Japan in August 2019, we have been preparing for its release. We aim to enhance our product lineup in the oncology field by harnessing the strength we amassed through the marketing of 33 anti-cancer drugs, while we continue to focus on the manufacture, research and development of biopharmaceuticals, including biosimilars.

Signing of co-promotion agreement with Bayer Yakuhin, Ltd. on NUBEQA® tablets

In February 2020, we signed a co-promotion agreement in Japan with Bayer Yakuhin, Ltd. for the new drug for prostate cancer, NUBEQA® tablets. The drug is an androgen receptor inhibitor that has been approved for manufacturing and sale as a therapeutic drug for castration-resistant prostate cancer without distant metastasis by Bayer Yakuhin. The manufacture and sale will be conducted by Bayer Yakuhin, while information promotion at medical facilities will be conducted by medical representatives (MR) of both companies.
 Since the launch of BLEO® in 1969, we have a long track record of providing information on urinary tract tumors. With NUBEQA® tablets, we will contribute to improving medical care through collection of safety information and provision of information on appropriate use together with Bayer Yakuhin to expand treatment options.
 Through this joint effort with Bayer Yakuhin to provide healthcare professionals with information on the proper use of NUBEQA®, Nippon Kayaku would like to expand treatment options for patients and further contribute to the improvement of healthcare.

Focus on expanding market share of Infliximab BS “NK” and Trastuzumab BS “NK”

We are focusing on biosimilars as a growth field following generic drugs. We aim to increase the market share of Infliximab BS “NK”, which is a biosimilar of Infliximab formulation, and Trastuzumab BS “NK”, which is a biosimilar of Trastuzumab formulation.
 Going forward, we hope to contribute to society through increased streamlining of medical expenses with steady supply of high quality and economic biosimilars, and strive to provide and collect information in cultivating biosimilars as a major pillar of our business.

Pharmaceutical Approvals Obtained (as of Nov 10, 2021)

New drugs launched

Biomedicines

PORTRAZZA® (Generic name:necitumumab)

Anti-cancer drugs

Capecitabine

Pemetrexed

Cancer-related drugs

Aprepitant capsules

Drugs approved for additional indications * Public knowledge-based application

INFLIXIMAB BS

Capecitabine

Carboplatin

Imatinib

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