April 26, 2021

Seikagaku Announces Launch of PyroSmart NextGen™
Recombinant LAL Reagent by Associates of Cape Cod, Inc.
Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) announced today that its overseas subsidiary
Associates of Cape Cod, Inc.*1 (Massachusetts, U.S.A.; “ACC”) has decided to launch PyroSmart
NextGen™ recombinant LAL reagent in April 2021.
PyroSmart NextGen™ is a new endotoxin-detecting*2 reagent commercialized by ACC that ismanufactured using recombinant technology resulting from research and development conducted
over many years at Seikagaku.
Applying recombinant technology to produce PyroSmart NextGen™ without using blood harvested
from horseshoe crabs, a raw material used in the manufacture of traditional Bacterial Endotoxin
Testing (BET) reagents will enable customers to achieve their sustainability goals without a forcedchange to test methodology or laboratory equipment.
PyroSmart NextGen™ is a next-generation BET reagent designed to deliver highly reliable
quantitation of endotoxins. It consists of recombinant proteins of Factor C, Factor B, and a
coagulating enzyme precursor, which are components of horseshoe crab blood cells. Since
PyroSmart NextGen™ follows the same enzymatic cascade pathway as naturally sourced products
and utilizes the same test methods and instrumentation, it is a direct replacement for traditional
naturally sourced reagents, ensuring consistency with the endotoxin-detecting reagents used in themanufacture of pharmaceuticals, such as injectable drugs and vaccines, as well as medical devices.
The market introduction of PyroSmart NextGen™ is the successful completion of focused efforts tolaunch a new class of BET reagent and is the next step in the revenue growth strategy as outlined
in Seikagaku’s mid-term management plan. ACC is responsible for development of the Seikagaku
Group’s LAL business in markets outside Japan, and will market the product globally. A productlaunch in Japan is planned for May or later in 2021.
PyroSmart NextGen™ Product Photo1

< Reference Information >*1 Associates of Cape Cod Inc. (ACC)
Associates of Cape Cod Inc. (ACC), a wholly owned subsidiary of Seikagaku, was the first FDAlicensed LAL manufacturer. ACC was established in 1974, became a Seikagaku subsidiary in
1997, and currently plays a central role in the global Bacterial Endotoxin Testing (BET) andclinical glucan detection sectors. ACC’s reagent production facility, located at their campus in
Falmouth Technology Park in Massachusetts, is vertically integrated with an end-to-end
manufacturing operation that extends from harvesting horseshoe crab blood cells, a reagent raw
material, to manufacturing, testing, packaging/labeling and distributing endotoxin and glucan invitro diagnostic agents. From that location, ACC also offers customers in-house contract testingservices for BET and clinical glucan product testing.
*2 Endotoxins
Endotoxins are a component of gram-negative bacteria. Since endotoxins exhibit strong
pyrogenic activity even in minute amounts and serious side effects can be triggered byendotoxin contamination of pharmaceuticals and other products, they must be rigorously
controlled pursuant to regulations in the manufacture of pharmaceutical products and medicaldevices.
< Cautionary Notes >This press release contains forward-looking statements regarding future management strategies orperformance forecasts. These descriptions are based on judgments derived from information that iscurrently available to Seikagaku and are subject to risk and uncertainty. Actual results and developments
may differ significantly from these descriptions due to various factors. Information about pharmaceuticalproducts or medical devices (including products currently in development) contained in this press releaseis not intended to constitute an advertisement or medical advice.

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