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Seikagaku (4548) · InitiativeAdvanced

Joint Development and Sales Partnership for SI-613 with ONO PHARMACEUTICAL CO.,LTD.

First written in FY2017. 5 of 8 entries say "Advanced", first in FY2018-Q2. Latest entry: FY2021.

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ProgressHeldSoftenedWorseAdvancedFY2018-Q2RestatedFY2019-Q2 – FY2020-Q1AdvancedFY2020-Q2 – FY20212017: 220172018: 120182019: 220192020: 120202021: 22021
Same theme, other companies
Joint Development and Sales Partnership for SI-613 with ONO PHARMACEUTICAL CO.,LTD.A theme 1 companies write about · 0 as a headwind · 1 as a tailwind

No other company in this theme has enough history to compare yet.

Full recordFilings, disclosures and news, newest first
  1. FY2021AdvancedAnnual report

    「In Japan, we obtained marketing approval on 23 March 2021 for the indications of osteoarthritis of the knee and hip under the name Joicur joint injection 30 mg, a joint-function improvement agent, and began sales in May of the same year.」

    For SI-613, jointly developed and commercialized with Ono Pharmaceutical Co., Ltd., the company obtained domestic marketing approval and launched Joyclu.
  2. FY2021-Q3AdvancedAnnual report

    「The Pharmaceutical Affairs and Food Sanitation Council's Second Subcommittee on Drugs deliberated on the product in January 2021, approving the indication for the knee and hip joints. The company will continue to take appropriate steps toward obtaining marketing authorization in coordination with its commercialization partner.」

    For SI-613, being jointly developed and commercialized with Ono Pharmaceutical Co., Ltd., the company received approval for the knee and hip joint indications and progressed to the stage of working with its commercialization partner to obtain marketing authorization.
  3. FY2020-Q3AdvancedAnnual report

    「Based on the results of 3 Phase III clinical trials conducted in Japan, we filed an application in January 2020 for domestic marketing approval for the indications of osteoarthritis of the knee, hip and ankle joints.」

    For SI-613, being jointly developed with Ono Pharmaceutical Co., Ltd., the company proceeded to file a domestic marketing authorization application based on the results of the 3 domestic Phase III clinical trials.
  4. FY2020-Q2AdvancedAnnual report

    「For SI-613, a treatment for osteoarthritis, 3 domestic Phase III clinical trials have been completed, and preparations are under way to file for approval during the current fiscal year based on their results.」

    For SI-613, being jointly developed with Ono Pharmaceutical Co., Ltd., all 3 domestic Phase III clinical trials were completed, and the company moved on to preparations for filing a domestic marketing authorization application.
  5. FY2020-Q1RestatedAnnual report

    「For SI-613, a treatment for osteoarthritis being jointly developed in Japan with Ono Pharmaceutical Co., Ltd., follow-up ended in June this year for the clinical trial covering osteoarthritis in four sites other than the knee, one of the three Phase III clinical trials being conducted jointly. The company then proceeded to the analysis of the data obtained.」

    The joint development of SI-613 with Ono Pharmaceutical Co., Ltd. is continuing, and 1 of the 3 Phase III clinical trials completed follow-up and moved to the data analysis stage. Specific trial progress is recorded in the development pipeline thread.
  6. FY2019-Q2RestatedAnnual report

    「・Promote the development of SI-613 as a next-generation treatment to improve joint function.」

    The company has reiterated its policy of developing SI-613 as a next-generation product as a key strategy in its medium-term management plan.
  7. FY2018-Q2AdvancedAnnual report

    「SI-613, a treatment for osteoarthritis: joint development and exclusive commercialization rights in Japan. Contract term: from the date of execution until the corresponding date 10 years after product launch, renewable every 2 years thereafter.」

    The collaboration with Ono Pharmaceutical Co., Ltd. on the joint development and commercialization of SI-613 in Japan progressed from the basic agreement stage to execution of a definitive agreement, establishing the joint development and exclusive commercialization rights in Japan and the contract term.
  8. FY2017First statedAnnual report

    「In May 2017, the company entered into a basic agreement with Ono Pharmaceutical Co., Ltd. concerning the joint development and commercialization of SI-613 in Japan. The parties will continue discussions toward executing a definitive agreement.」

    The company entered into a basic agreement with Ono Pharmaceutical Co., Ltd. for the joint development and commercialization of SI-613 in Japan and moved into discussions toward a definitive agreement.
Moved together

"Strengthening Core Technologies and the Development Pipeline in Glycoscience" moved the same way as this thread, in the same document, in 5 of its 8 moves.

522222★123456
  1. ★This thread
  2. 1Strengthening Core Technologies and the Development Pipeline in Glycoscience5×
  3. 2Developing the LAL business as one of the pillars of growth2×
  4. 3Strengthening Artz Sales Expansion into Outlying Chinese Regions2×
  5. 4Strengthening the Opegane Product Lineup through the Launch of Shellgan2×
  6. 5Tightening Reimbursement for Hyaluronic Acid Injections in the U.S.2×
  7. 6Launch of the U.S. Phase I/II Clinical Trial of SI-7222×

★ is this thread; numbers match the list above. The number on a line is how many documents both moved the same way in; lines between the other threads count the documents they moved together in too. Threads that move together often sit closer.

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