Domestic Launch of SI-6603 and U.S. Approval
First written in FY2016. 14 of 33 entries say "Advanced", first in FY2017-Q1. Latest entry: 2026-09-10.
No other company in this theme has enough history to compare yet.
- 2026-09-10SoftenedOccurring Fact
「The reasons for the FDA's issuance of the CRL this time include the fact that deficiencies identified during an inspection of the drug-substance manufacturing facility had not been fully resolved, as well as deficiencies identified during a newly conducted cGMP inspection of the facility of the contract manufacturer for the drug product, which were judged to require corrective action.」
Following resubmission in March 2026, SI-6603 received a CRL, indicating that approval cannot be obtained based on the current application. The company is considering an early resubmission toward obtaining approval. - FY2026AdvancedAnnual report
「We subsequently completed our response to the FDA's additional observations and resubmitted the application to the FDA in March 2026.」
For SI-6603, the company completed its response to observations concerning manufacturing facilities, the active pharmaceutical ingredient and finished-product controls, and resubmitted the U.S. application in March 2026. Approval has not yet been reported. - 2026-05-13AdvancedEarnings
「We resubmitted the application to the FDA in March 2026.」
SI-6603 progressed to the resubmission stage after the company completed its response to the issues identified following the failure to obtain FDA approval. Approval has not yet been obtained. - FY2025SoftenedAnnual report
「In March 2025, we received a complete response letter from the U.S. Food and Drug Administration (FDA), and approval was not obtained. Although we aim to resubmit SI-6603 within 1 year of receiving the letter, a U.S. launch during the medium-term management plan period is difficult, making it difficult to achieve the numerical targets of ¥40.0 billion in sales and ¥7.0 billion in operating profit.」
SI-6603 was not approved in the FDA review, making a U.S. launch during the medium-term management plan period difficult. The company stated that it aims to resubmit within 1 year. - FY2025-H1AdvancedAnnual report
「In March 2024, we filed a Biologics License Application (BLA) for SI-6603, and in May of the same year the BLA was accepted by the U.S. Food and Drug Administration (FDA). We are currently responding to the review toward approval.」
SI-6603's U.S. development advanced to the review stage following the BLA filing and FDA acceptance. Approval had not yet been obtained. - FY2024-Q3RestatedAnnual report
「The number of Hernicore units supplied to medical institutions and our sales declined.」
The company continued to report declines in units supplied and sales for Hernicore, which has already been launched in Japan. - FY2024-Q3RestatedAnnual report
「Follow-up in the additional Phase III clinical trial was completed in March 2023, and in May of the same year we obtained topline results showing a statistically significant improvement in the primary endpoint. We are currently preparing for an early filing for approval.」
Following the topline results from the additional U.S. Phase III trial, SI-6603 remains in the preparation stage for an early approval application. - FY2024-Q2Units supplied and sales declinedAnnual report
「The number of Hernicore units supplied to medical institutions and our sales declined.」
The company reported declines in units supplied and sales for Hernicore, which had already been launched in Japan. There was no change in its approval or launch status. - FY2024-Q1AdvancedAnnual report
「Follow-up in the additional Phase III clinical trial was completed in March 2023, and in May of the same year we obtained topline results showing a statistically significant improvement in the primary endpoint. We will now prepare for an early filing for approval.」
SI-6603 completed follow-up in the additional U.S. Phase III trial and obtained topline results in May 2023 showing a statistically significant improvement in the primary endpoint. It moved to the preparation stage for an early U.S. approval application. - FY2023-Q1Units supplied remained at the prior-year level, while sales increased due to shipment timing adjustmentsAnnual report
「The number of Hernicore units supplied to medical institutions remained at the level of the same period of the previous year, but our sales increased because of shipment timing adjustments.」
Units supplied remained at the prior-year level, while the company's sales increased because of shipment timing adjustments. - FY2022AdvancedAnnual report
「Although the trial schedule had been delayed by the spread of COVID-19, patient enrollment in the additional Phase III clinical trial was completed in March 2022. Following a 1-year follow-up period, we plan to analyze the results and prepare the approval application.」
SI-6603 completed patient enrollment in the additional U.S. Phase III trial in March 2022 and progressed to the 1-year follow-up stage, followed by analysis and preparation of the approval application. - FY2022-Q2AdvancedAnnual report
「The number of Hernicore units supplied to medical institutions and our sales increased, reflecting the rebound from the decline in outpatient visits associated with the spread of COVID-19 in the same period of the previous year and the strengthening of information activities for medical institutions with our marketing partner.」
The company strengthened information activities with its marketing partner and reported increases in units supplied and sales. - FY2022-Q1AdvancedAnnual report
「The number of Hernicore units supplied to medical institutions increased, reflecting the rebound from the decline in outpatient visits associated with the spread of COVID-19 in the same period of the previous year and the steady increase in new institutions supplied. Our sales declined because of shipment timing.」
Units supplied increased because new institutions continued to be added and the prior-year COVID-19 impact abated. The company's sales declined because of shipment timing. - FY2021New institutions supplied increased, but units supplied remained at the prior-year levelAnnual report
「Although the number of new institutions supplied with Hernicore increased steadily, the number of units supplied to medical institutions remained at the prior-year level because of the decline in outpatient visits associated with the spread of COVID-19. Our sales increased because of shipment timing.」
New institutions supplied increased, but units supplied remained at the prior-year level because of fewer outpatient visits, while the company's sales increased due to shipment timing. - FY2021-Q3RestatedAnnual report
「We began an additional Phase III clinical trial in the U.S. in February 2018 and were proceeding with a plan to complete follow-up in November 2022, but the trial schedule has been delayed, partly because the spread of COVID-19 in the U.S. increased trial suspensions at some medical institutions and subjects not attending visits.」
Although SI-6603 had already been launched in Japan, the additional trial toward U.S. approval remained delayed and continued based on the plan to complete it in November 2022. - FY2021-Q2AdvancedAnnual report
「Although Hernicore was affected by a decline in outpatient visits due to the spread of COVID-19, the number of units supplied to medical institutions increased because of steady growth in new institutions supplied. Our sales declined because shipments were high in the same period of the previous year. We continue to provide information to ensure appropriate use and safety and to collect post-marketing safety information so that more patients can access treatment.」
Despite fewer outpatient visits, units supplied increased as the number of new institutions supplied grew. Sales declined because shipments were high in the same period of the previous year, while appropriate-use and safety activities continued. - FY2021-Q1AdvancedAnnual report
「For Hernicore, the lumbar disc herniation treatment, we are working to provide more patients with access to treatment by providing information to ensure appropriate use and safety and collecting post-marketing safety information. Although our results in the first quarter were affected by a decline in outpatient visits due to the spread of COVID-19, the number of units supplied to medical institutions and our sales increased because of steady growth in new institutions supplied.」
For Hernicore, which had already been launched in Japan, the company continued its appropriate-use and safety activities. Despite fewer outpatient visits due to COVID-19, units supplied and sales increased as the number of new institutions supplied grew. - FY2020SoftenedAnnual report
「In addition, the spread of COVID-19 in the U.S. has led to an increase in trial suspensions at some medical institutions and in subjects not attending visits, causing delays in the trial's progress.」
While the Japanese launch of SI-6603 had been achieved, the additional trial toward U.S. approval was further delayed by trial suspensions and missed visits related to COVID-19. - FY2020-Q3RestatedAnnual report
「The number of Hernicore units supplied to medical institutions remained firm, and our sales also increased. We will continue working with our marketing partner to provide information to medical institutions on appropriate use and safety and seek steady market penetration.」
The company continued to report increases in units supplied and sales, together with ongoing information activities concerning appropriate use and safety. - FY2020-Q2AdvancedAnnual report
「The number of Hernicore units supplied to medical institutions increased steadily, and our sales also increased. We will continue working with our marketing partner to provide information to medical institutions on appropriate use and safety and to promote gradual market penetration.」
The company reported increases in units supplied to medical institutions and its own sales, while continuing information activities and gradual market penetration. - FY2020-Q1RestatedAnnual report
「For Hernicore, the lumbar disc herniation treatment launched in August 2018, we are working with our marketing partner to provide information to medical institutions on appropriate use and safety and to achieve gradual market penetration. Market penetration is progressing steadily.」
Following the domestic launch, the company continued providing information on appropriate use and safety and pursuing gradual adoption. It reported steady market penetration. - FY2019AdvancedAnnual report
「Although development of SI-6603, the lumbar disc herniation treatment known domestically as Hernicore, took time to reach approval, the Japanese launch was achieved in August 2018.」
Following Japanese marketing approval, SI-6603 was launched domestically as Hernicore in August 2018. U.S. development remained at the stage of conducting additional trials. - FY2019-Q3RestatedAnnual report
「For Hernicore, the lumbar disc herniation treatment launched in August 2018, we are actively providing information to medical institutions to promote appropriate use and ensure safety, while working with our marketing partner to achieve gradual market penetration. As this was the first year after launch, our sales were small.」
Following the Japanese launch, the company continued providing information to support appropriate use and safety and pursued gradual adoption with its marketing partner. Company sales were small in the first year after launch. - FY2019-Q2AdvancedAnnual report
「KAKEN PHARMACEUTICAL CO.,LTD., our marketing partner, began selling Hernicore, the lumbar disc herniation treatment, on 1 August 2018. We will seek gradual market penetration while promoting appropriate use.」
Following Japanese marketing approval, SI-6603 was launched as Hernicore on 1 August 2018. The company also stated that it would promote gradual adoption while encouraging appropriate use. - FY2019-Q1AdvancedAnnual report
「Hernicore, the lumbar disc herniation treatment for which domestic marketing approval was obtained in March 2018, will be launched by KAKEN PHARMACEUTICAL CO.,LTD., our marketing partner, on 1 August 2018.」
SI-6603 received Japanese marketing approval and a launch date through the marketing partner was set. Concrete progress toward the Japanese launch was made, but the product had not yet launched as of the filing date. - FY2018-Q3RestatedAnnual report
「We aim to launch the lumbar disc herniation treatment SI-6603 in Japan, obtain U.S. approval, and enter new markets with existing products.」
The medium-term plan continues to include the Japanese launch and U.S. approval of SI-6603. This filing reports no new approval or trial results. - FY2018-Q2SoftenedAnnual report
「The Phase III clinical trial of SI-6603 conducted in the U.S. showed pharmacological effects, but did not demonstrate a statistically significant improvement in the primary endpoint, reduction in leg pain 13 weeks after administration. No major concerns such as adverse effects were identified, and the safety of the product was confirmed. We will consider and prepare for an early repeat of the Phase III clinical trial in the U.S. in consultation with the U.S. Food and Drug Administration (FDA) and Ferring Pharmaceuticals, our licensee.」
The Phase III trial for U.S. approval did not demonstrate a statistically significant improvement in its primary endpoint, so the company moved to considering and preparing for a repeat Phase III trial. Safety was confirmed. - FY2018-Q1RestatedAnnual report
「Under this plan, we aim to further expand sales in the U.S., our priority region, obtain Japanese approval and U.S. approval for SI-6603, a treatment for lumbar disc herniation, and enter new markets with existing products.」
The target of launching SI-6603 in Japan and obtaining U.S. approval remains part of the medium-term plan. - FY2017RestatedAnnual report
「For SI-6603 in Japan, for which we filed an application for marketing approval with the Ministry of Health, Labour and Welfare in January 2014, the review of quality control in the manufacturing process is continuing. We will continue working toward early approval.」
Japanese approval had not yet been obtained; the review of quality control matters was continuing, and efforts toward early approval were under way. - FY2017-Q3RestatedAnnual report
「Under this plan, we aim to further expand sales in the U.S., our priority region, obtain Japanese approval and U.S. approval for SI-6603, a treatment for lumbar disc herniation, and enter new markets with existing products.」
The target of launching SI-6603 in Japan and obtaining U.S. approval remains part of the medium-term plan. - FY2017-Q2SoftenedAnnual report
「We had aimed to obtain Japanese approval for the lumbar disc herniation treatment SI-6603 during the fiscal year ending March 2017, but the review of quality control matters has taken longer than expected, making approval during the fiscal year difficult. We will continue working toward approval.」
The target of obtaining Japanese approval during the fiscal year ending March 2017 was unlikely to be met because the review of quality control matters had taken longer than expected. - FY2017-Q1AdvancedAnnual report
「Research and development expenses increased significantly as the U.S. open-label study of the lumbar disc herniation treatment SI-6603 progressed.」
The filing reports progress in the U.S. open-label study of SI-6603. It does not state that the Japanese launch or U.S. approval had been completed. - FY2016First statedAnnual report
「We aim to launch the lumbar disc herniation treatment SI-6603 in Japan and obtain approval in the U.S.」
In Japan, the approval review was continuing and approval was targeted during the fiscal year ending March 2017. In the U.S., patient enrollment in the Phase III trial had been completed and follow-up was under way.