GA101 global Phase 3 clinical trial
First written in FY2017-Q1. 15 of 24 entries say "Restated". Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AdvancedAnnual report
「For GA101 (product name: Gazyva® intravenous infusion 1,000 mg; generic name: obinutuzumab), CHUGAI PHARMACEUTICAL CO.,LTD. filed an application to expand the indication to idiopathic nephrotic syndrome in May 2026.」
In addition to the existing clinical trials, an application to expand GA101's indication to idiopathic nephrotic syndrome was filed in May 2026. - 2026-05-15AdvancedRevision to earnings forecast
「GA101（製品名：ガザイバ®点滴静注1000mg、一般名：オビヌツズマブ）」については、中外製薬株式会社が、2026年5月に特発性ネフローゼ症候群を対象とした適応拡大申請を行いました。」
GA101について、既存の第三相試験に加え、特発性ネフローゼ症候群向けの適応拡大申請段階へ進んだ。 - FY2025-H1RestatedAnnual report
「For GA101 (product name: Gazyva® intravenous infusion 1,000 mg; generic name: obinutuzumab), a Phase 3 trial in lupus nephritis has been underway jointly with CHUGAI PHARMACEUTICAL CO.,LTD. since June 2022, a Phase 3 trial in pediatric idiopathic nephrotic syndrome has been underway since March 2023, and a Phase 3 trial in systemic lupus erythematosus without nephritis has been underway since October 2023.」
Three Phase 3 trials of GA101, targeting lupus nephritis, pediatric idiopathic nephrotic syndrome and systemic lupus erythematosus without nephritis, remain ongoing. - FY2024-Q3RestatedAnnual report
「For GA101 (product name: Gazyva® intravenous infusion 1,000 mg; generic name: obinutuzumab), a Phase 3 trial in lupus nephritis has been underway jointly with CHUGAI PHARMACEUTICAL CO.,LTD. since June 2022, a Phase 3 trial in pediatric idiopathic nephrotic syndrome has been underway since March 2023, and a Phase 3 trial in systemic lupus erythematosus without nephritis has been underway since October 2023.」
Three Phase 3 trials of GA101, targeting lupus nephritis, pediatric idiopathic nephrotic syndrome and systemic lupus erythematosus without nephritis, remain ongoing. - FY2024-Q2AdvancedAnnual report
「For GA101 (product name: Gazyva® intravenous infusion 1,000 mg; generic name: obinutuzumab), a Phase 3 trial in lupus nephritis has been underway jointly with CHUGAI PHARMACEUTICAL CO.,LTD. since June 2022, and a Phase 3 trial in pediatric idiopathic nephrotic syndrome has been underway since March 2023. In addition, a Phase 3 trial in systemic lupus erythematosus without nephritis was initiated in October 2023.」
In addition to the two existing Phase 3 trials, a Phase 3 trial of GA101 targeting systemic lupus erythematosus without nephritis was initiated in October 2023. - FY2024-Q1RestatedAnnual report
「For GA101 (product name: Gazyva® intravenous infusion 1,000 mg; generic name: obinutuzumab), a Phase 3 trial in lupus nephritis has been underway jointly with CHUGAI PHARMACEUTICAL CO.,LTD. since June 2022. A Phase 3 trial in pediatric idiopathic nephrotic syndrome has also been underway since March 2023.」
Two Phase 3 trials of GA101, targeting lupus nephritis and pediatric idiopathic nephrotic syndrome, remain ongoing. - FY2023AdvancedAnnual report
「For GA101 (brand name: Gazyva® intravenous infusion 1,000 mg, generic name: obinutuzumab), the company is conducting a Phase 3 clinical trial for lupus nephritis jointly with CHUGAI PHARMACEUTICAL CO.,LTD., which began in June 2022. In addition, the company began a Phase 3 clinical trial for pediatric idiopathic nephrotic syndrome in March 2023.」
For GA101, a Phase 3 trial in pediatric idiopathic nephrotic syndrome was initiated in March 2023, in addition to the Phase 3 trial in lupus nephritis. - FY2023-Q2RestatedAnnual report
「・For GA101 (brand name: Gazyva® intravenous infusion 1,000 mg, generic name: obinutuzumab), the company began a Phase 3 clinical trial for lupus nephritis jointly with CHUGAI PHARMACEUTICAL CO.,LTD. in June 2022.」
The company reiterates that it is continuing the domestic Phase 3 clinical trial for lupus nephritis that began in June 2022 for GA101. - FY2023-Q1AdvancedAnnual report
「・For the lupus nephritis treatment GA101 (brand name: Gazyva® intravenous infusion 1,000 mg, generic name: obinutuzumab), the company began a domestic Phase 3 clinical trial jointly with CHUGAI PHARMACEUTICAL CO.,LTD. in June 2022.」
For GA101, the company began a domestic Phase 3 clinical trial for lupus nephritis in June 2022, in addition to the existing follicular lymphoma indication. - FY2021RestatedAnnual report
「In the pharmaceutical business, sales increased for royalty income from overseas sales of Uptravi, Defitelio, a treatment for hepatic veno-occlusive disease, Gazyva, a treatment for CD20-positive follicular lymphoma, sales of new products including Uptravi, and joint promotion income, among other items.」
Gazyva, derived from GA101, contributed to growth in pharmaceutical business sales together with joint promotion income and other items. - FY2021-Q3RestatedAnnual report
「In the pharmaceutical business, sales increased for royalty income from overseas sales of Uptravi, Defitelio, a treatment for hepatic veno-occlusive disease, Gazyva, a treatment for CD20-positive follicular lymphoma, sales of new products including Uptravi, and joint promotion income, among other items.」
GA101 (Gazyva), together with joint promotion income and other items, contributed to growth in pharmaceutical business sales. - FY2021-Q2RestatedAnnual report
「In the pharmaceutical business, sales of Uptravi, royalty income from its overseas sales, Gazyva, a treatment for CD20-positive follicular lymphoma, and co-promotion income increased. In addition, Defitelio, a treatment for sinusoidal obstruction syndrome launched in September 2019, contributed to net sales of ¥50.296 billion, an increase of 1.0% year on year.」
Following the start of joint sales, GA101 (Gazyva), together with Uptravi and other products, contributed to growth in pharmaceutical business sales. - FY2021-Q1RestatedAnnual report
「In the pharmaceutical business, sales increased for Uptravi, royalty income from overseas sales of the product, Gazyva, a treatment for CD20-positive follicular lymphoma, and joint promotion income, among other items.」
Following the start of joint sales, GA101 (Gazyva), together with Uptravi and other products, contributed to growth in pharmaceutical business sales. - FY2020-Q3RestatedAnnual report
「In the pharmaceutical business, revenue from industrial property rights and other sources declined compared with the same period of the previous year, when milestone income was recorded from Uptravi, an in-house-developed treatment for pulmonary arterial hypertension. However, growth in domestic sales of Uptravi, Vidaza, a treatment for myelodysplastic syndromes, and Zalutia, a treatment for urinary disorders associated with benign prostatic hyperplasia, together with Gazyva, a treatment for CD20-positive follicular lymphoma launched jointly with CHUGAI PHARMACEUTICAL CO.,LTD. in August 2018, contributed to net sales of ¥76.665 billion, an increase of 1.1% year on year.」
Sales of GA101 (Gazyva) continued to contribute to higher pharmaceutical business sales following the start of joint sales. - FY2020-Q1RestatedAnnual report
「In the pharmaceutical business, domestic sales of Uptravi, an in-house-developed treatment for pulmonary arterial hypertension, royalty income from its overseas sales, Vidaza, a treatment for myelodysplastic syndromes, and Zalutia, a treatment for urinary disorders associated with benign prostatic hyperplasia, increased. In addition, Gazyva, a treatment for CD20-positive follicular lymphoma launched jointly with CHUGAI PHARMACEUTICAL CO.,LTD. in August last year, contributed to net sales of ¥25.652 billion, an increase of 6.6% year on year.」
Following the start of joint sales, GA101 (Gazyva), together with Uptravi and other products, contributed to higher pharmaceutical business sales. - FY2019-Q3RestatedAnnual report
「In addition, sales of Gazyva, a treatment for CD20-positive follicular lymphoma jointly launched with CHUGAI PHARMACEUTICAL CO.,LTD. in August of the previous year, and milestone income from Uptravi, among other factors, contributed to sales increasing 13.1% year on year to ¥75,798 million.」
Following approval and launch, GA101 (Gazyva) contributed to higher pharmaceutical business sales. - FY2019-Q2AdvancedAnnual report
「・The company had been jointly developing the follicular lymphoma treatment GA101 (brand name: Gazyva®, generic name: obinutuzumab) with CHUGAI PHARMACEUTICAL CO.,LTD. CHUGAI PHARMACEUTICAL CO.,LTD. filed for marketing approval in August of the previous year, approval was obtained on 2 July of the current year for the indication of CD20-positive follicular lymphoma, and the product was launched on 29 August.」
GA101 progressed beyond the marketing approval application and approval stages and was launched on 29 August 2018. - FY2019-Q1AdvancedAnnual report
「・The company had been jointly developing the follicular lymphoma treatment GA101 (brand name: Gazyva®, generic name: obinutuzumab) with CHUGAI PHARMACEUTICAL CO.,LTD. CHUGAI PHARMACEUTICAL CO.,LTD. filed for marketing approval in August of the previous year, and approval was obtained on 2 July of the current year for the indication of CD20-positive follicular lymphoma.」
GA101 progressed from the joint development and marketing approval application stage to the stage of obtaining approval for the indication of CD20-positive follicular lymphoma. - FY2018-Q3RestatedAnnual report
「・The company had been jointly developing the follicular lymphoma treatment GA101 (generic name: obinutuzumab) with CHUGAI PHARMACEUTICAL CO.,LTD., which filed for marketing approval in August 2017 for the indication of CD20-positive B-cell follicular lymphoma.」
The company reiterates that GA101 was at the marketing approval application stage in August 2017. - FY2018-Q2AdvancedAnnual report
「The company had been jointly developing the follicular lymphoma treatment GA101 (generic name: obinutuzumab) with CHUGAI PHARMACEUTICAL CO.,LTD., which filed for marketing approval in August 2017 for the indication of CD20-positive B-cell follicular lymphoma.」
GA101 progressed from the joint development and Phase 3 clinical trial stage to the stage of filing for marketing approval for CD20-positive B-cell follicular lymphoma. - FY2018-Q1RestatedAnnual report
「・For the non-Hodgkin lymphoma treatment GA101 (generic name: obinutuzumab), the company is conducting a Phase 3 international joint clinical trial with CHUGAI PHARMACEUTICAL CO.,LTD. in patients with low-grade non-Hodgkin lymphoma.」
The company continues its joint international Phase 3 clinical trial of GA101 with CHUGAI PHARMACEUTICAL CO.,LTD. - FY2017-Q3RestatedAnnual report
「For the non-Hodgkin lymphoma treatment GA101 (generic name: obinutuzumab), the company is conducting a Phase 3 international joint clinical trial with CHUGAI PHARMACEUTICAL CO.,LTD. in patients with low-grade non-Hodgkin lymphoma.」
The company continues its joint international Phase 3 clinical trial of GA101 with CHUGAI PHARMACEUTICAL CO.,LTD. - FY2017-Q2RestatedAnnual report
「For the non-Hodgkin lymphoma treatment GA101 (generic name: obinutuzumab), the company is conducting a Phase 3 international joint clinical trial with CHUGAI PHARMACEUTICAL CO.,LTD. in patients with low-grade non-Hodgkin lymphoma.」
The company reiterates that it is conducting a joint international Phase 3 clinical trial of GA101 with CHUGAI PHARMACEUTICAL CO.,LTD. - FY2017-Q1First statedAnnual report
「For the non-Hodgkin lymphoma treatment GA101 (generic name: obinutuzumab), the company is conducting a Phase 3 international joint clinical trial with CHUGAI PHARMACEUTICAL CO.,LTD. in patients with low-grade and intermediate- to high-grade non-Hodgkin lymphoma.」
The company is conducting a joint international Phase 3 clinical trial of GA101 with CHUGAI PHARMACEUTICAL CO.,LTD.