＜Pharmaceuticals＞

Development code / Product name, etc.	Indication	Target market	Stage	In-house In-license
SI-6603 Condoliase	Lumbar disk herniation	U.S.	Phase III	In-house
SI-613 Diclofenac Etalhyaluronate Sodium	Osteoarthritis	Japan	Phase III	In-house
	Knee osteoarthritis	U.S.	Phase II
SI-613-ETP Diclofenac Etalhyaluronate Sodium	Enthesopathy	Japan	Late-Stage Phase II
SI-614 Modified Hyaluronate	Dry eye	U.S.	Phase II / III	In-house

＜Medical Device＞

Development code / Product name, etc.	Indication	Target market	Stage	In-house In-license
SI-449 Cross-linked Chondroitin Sulfate	Adhesion barrier	Japan	Pilot study	In-house

(As of May 21, 2018)

SI-6603 is  a treatment option for lumbar disc herniation with the active pharmaceutical ingredient of condoliase. This is therapeutic agent with intradiscal administration. It does not require a general anesthesia and is less invasive to the patient than surgical treatment. As this agent specifically degrades GAGs in the nucleus pulposus, resulting in decrease in the pressure on the nerve root by a single administration of the agent, Seikagaku believes that this new treatment option is able to contribute to quality of life of the patient.

The Japanese Ministry of Health, Labour and Welfare (MHLW) approved the New Drug Application (NDA) of HERNICORE 1.25 units for intradiscal injection in Japan, indicated for the treatment of lumbar disc herniation, on March 23, 2018. HERNICORE was launched on August 1, 2018.

SI-613 is a formulation in which hyaluronic acid and a diclofenac (anti-inflammatory drug)

are chemically bound using Seikagaku’s own proprietary technology. SI-613 was designed to provide pain relief and anti-inflammatory effect by sustained release of diclofenac, and the joint function improving effect by hyaluronic acid. It is expected to provide prompt and sustained relief of the severe pain and inflammation associated with osteoarthritis and enthesopathy. Since SI-613 is administered directly into the joint cavity or near the tendon or ligament enthesis as an injectable treatment, the transfer of the NSAID into the systemic blood is extremely low, and it is expected to mitigate the risk of side effects reported in oral or transdermal administration of NSAID.

SI-614 is a modified hyaluronate that is produced using the Company’s proprietary technology. Ocular instillation of SI-614 in patients with dry eye is expected to protect
the ocular surface and promote corneal wound healing.

SI-449 is a powdered adhesion barrier whose main ingredient is cross-linked chondroitin sulfate developed using Seikagaku’s own glycosaminoglycan cross-linking technology. SI-449, which has the property of absorbing moisture and swelling, is expected to prevent or mitigate post-operative adhesion formation by forming a barrier between the surgical wound site and surrounding tissues after application.

Seikagaku is considering introducing SI-449 not only in Japan, but in global.