Investor Relations

Pharmaceuticals Business

Kazuto Koizumi Member of the Board Managing Director
Head of the 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

As part of national social security reforms, the government shows that the pharmaceutical industry shall change to have an industrial structure with high drug discovery capabilities led by the pursuit for further innovation, etc. Further, steps toward improving the quality of healthcare and alleviating national burden, based on a basic policy that calls for a dramatic overhaul of the drug pricing system, are expected.
 Amidst these circumstances, the pharmaceuticals business contributes to society through medical expense optimization made possible through the stable supply of cost-effective, high quality, inexpensive generic drugs and biosimilars in the cancer treatment field. Additionally, we have taken the first steps towards transitioning to the domestic production of biosimilars sought after for industrial development.
 We are also growing the pharmaceuticals business to provide further improvements to healthcare by responding to various healthcare needs, such as improving the effectiveness and side effects of existing medications through research and development into polymeric micelle anti-cancer drugs.

Initiatives under Mid-term Business Plan “KAYAKU Next Stage

In the specialty field, we will continue to promote clinical trials of NK105 within KAYAKU Next Stage, with a scheduled completion of December 2020.
 Additionally, we are continuing preparations of Portrazza®, a treatment for squamous cell non-small cell lung cancer introduced as a new biopharmaceutical Nippon Kayaku is hoping to launch sometime during the fiscal year ended March 31, 2020. Efforts are also underway to manufacture Portrazza® locally in Japan. Looking ahead, we will actively pursue to alliance activities to further bolster our product lineup.
 With regard to biosimilars—an area of focus for growth—the addition of Trastuzumab BS to our lineup in the cancer field has called for even greater information provision and collection activities. We will look to leverage our expertise in the cancer field to help grow our biosimilars into a major pillar of the Company’s business.
 In terms of generic anti-cancer drugs, we will continue to pursue difficult challenges relating to unique formulations in order to ensure the stable supply of medicines while meeting the needs of those working in the field of healthcare.
 Looking ahead, we will continue to contribute to society by “continuously providing patients with the best products through ceaseless progress and the combined forces of our consciences” based on the KAYAKU spirit.

Key Themes in Mid-term Business Plan

Theme Details of initiatives
Establishing safety and quality management systems
  • Continuously operate a quality assurance system that is uniform to the Pharmaceuticals Group and strengthen response capabilities to maintain stable operations
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
  • Establish Cultivecs business platform, an R&D structure at a pharmaceuticals research laboratories, and manufacturing equipment at the Takasaki Plant to enable domestic bio manufacturing
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.

Specialty drugs

Phase II clinical trials of NK105, a polymeric micelle anti-cancer drug, now underway

Phase II clinical trials of NK105, a proprietary-developed polymeric micelle anti-cancer drug, have been continuing since February 2018, testing its effectiveness in breast cancer patients. NK105 is a DDS (Drug Delivery System) pharmaceutical containing paclitaxel as an active ingredient within a polymeric micelle. We will continue to look to meeting healthcare needs by improving the effectiveness and side effects of existing anti-cancer drugs.

PORTRAZZA® go on sale

Portrazza® Injection went on sale in November 2019. Portrazza® Injection is a human anti-EGFR monoclonal antibody that Eli Lilly and Company has been selling in Europe and the US since 2015 as a therapeutic agent (market name: Portrazza™) for advanced or metastatic squamous non-small cell lung cancer. Nippon Kayaku took over the marketing authorization holder from Eli Lilly Japan on August 1st 2019.

Biosimilars

Expanded indication of TRASTUZUMAB BS “NK” for breast cancer

TRASTUZUMAB BS NK, a Trastuzumab (gene recombination pharmaceutical) biosimilar went on sale in August 2018 with an indication for advanced/relapsed gastric cancer preventing curative resection where an overexpression of HER2 is detected. An additional indication was later applied for breast cancer where an overexpression of HER2 is detected, eliminating the indication mismatch with the prior drug in August 2019.

Generic drugs

Expanded indication for the TEMOZOLOMIDE Tab. “NK”

Indications for the generic drug TEMOZOLOMIDE Tab. “NK” 20 mg and 100 mg, which was indicated for use for malignant glioma, were expanded in February 2019 to include indications for use for relapsed or refractory Ewing sarcoma.

GEFITINIB Tab. “NK” go on sale

GEFITINIB Tab. “NK” 250 mg, a generic drug that acts as an anti-malignant tumor agent/EGFR (epidermal growth factor receptor) inhibitor, went on sale in June 2019.

CAPECITABINE “NK” and APREPITANT “NK” capsules go on sale

CAPECITABINE Tab. “NK” 300 mg, the anti-cancer agent generic drug, and APREPITANT capsules 125 mg “NK”, 80 mg “NK” and Set “NK”, the selective NK1 receptor antagonist antiemetic agent, went on sale in December 2019.

Pharmaceutical Approvals Obtained (as of Apr 22, 2019)

New drugs launched

Biomedicines

PORTRAZZA® (Generic name:necitumumab)

Anti-cancer drugs

GEFITINIB

Capecitabine

Cancer-related drugs

Aprepitant capsules

Drugs approved for additional indications * Public knowledge-based application

INFLIXIMAB BS

TRASTUZUMAB BS

TEMOZOLOMIDE

Status of Drug Development (as of Nov 7, 2019)

Drugs currently in clinical trials

Biosimilars

CT-P10 (Generic name: rituximab)

Anti-cancer drugs

NK105 (Polymeric micelle paclitaxel)

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