-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Ovarian cancer ranks seventh in the ranking of common cancers in women, with 295,525 new cases in 2018.
Since more than 60% of ovarian cancer patients are at an advanced stage when they are diagnosed, and about 70% of patients have relapsed due to chemotherapy resistance, the mortality rate of ovarian cancer is generally high.
In China, ovarian cancer is the gynecological cancer with the highest mortality rate, with approximately 22,500 deaths every year.
The five-year survival rate of ovarian cancer patients in China is about 40%.
On May 7, 2021, China National Medical Products Administration (NMPA) conditionally approved Baihuize® for the treatment of advanced ovarian cancer and fallopian tube cancer that have received at least two lines of chemotherapy in the past and carry germline BRCA (gBRCA) mutations Or patients with primary peritoneal cancer.
Full approval for this indication will depend on the results of confirmatory clinical trials in progress.
The Center for Drug Evaluation (CDE) included relevant new drug marketing authorization applications into priority review in July 2020.
BeiGene is preparing for commercialization-related work and is expected to complete the commercial release of Baihui Ze® within this month.
NMPA's conditional approval of Baihuize® for the treatment of patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer is based on the key phase 2 partial clinical results of a phase 1/2 clinical trial (NCT03333915).
Baihuize® (Pamipali) is a PARP1 and PARP2 inhibitor.
Preclinical models have shown that it has pharmacological properties such as penetrating the blood-brain barrier and capturing PARPDNA complexes.
Independently developed by scientists from BeiGene at the Beijing R&D Center, Baihuize® is currently undergoing global clinical development as a monotherapy or in combination with other drugs to treat a variety of malignant solid tumors.
So far, more than 1,200 patients have been enrolled in clinical trials of Baihuize®.
A total of 113 patients with high-grade epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) with gBRCA mutation who have received at least two standard chemotherapy in the past were enrolled in the key phase 2 part of the trial in China, including 90 patients with advanced platinum-sensitive ovarian cancer (PSOC) and 23 patients with advanced platinum-resistant ovarian cancer (PROC).
The effectiveness data of Baihuize® is based on 101 patients with evaluable efficacy and was evaluated by the Independent Review Committee (IRC) according to RECIST v1.
1, including 82 patients with PSOC and 19 patients with PROC.
The median follow-up time for PSOC patients was 17.
0 months, the objective response rate (ORR) was 68.
3% (95% CI: 57.
1, 78.
1), and the median duration of response (DoR) was 13.
8 months (95% CI: 10.
97) , 20.
73); the median follow-up time of PROC patients was 11.
6 months, the ORR was 31.
6% (95%CI: 12.
6, 56.
6), and the median DoR was 11.
1 months (95%CI: 4.
21, 16.
59).
The overall safety profile of Baihuize® is based on 317 patients who received Baihuize® monotherapy in 3 clinical trials.
The most common adverse reactions (≥10%) are anemia, nausea, leukopenia, neutropenia, vomiting, fatigue, thrombocytopenia, loss of appetite, diarrhea, abdominal pain, aspartate aminotransferase (AST) Elevated, elevated alanine aminotransferase (ALT), elevated blood bilirubin, and lymphopenia.
55.
8% of patients experienced grade 3 and above adverse reactions, the most common (≥1%) were anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, fatigue, diarrhea, Nausea and elevated AST.
21.
5% of patients experienced serious adverse reactions, the most common (≥1%) were anemia and leukopenia. The most common adverse reactions (≥10%) reported in this key phase 2 clinical trial in China were anemia, leukopenia, nausea, neutropenia, vomiting, thrombocytopenia, loss of appetite, fatigue, abdominal pain, and elevated ALT.
High, diarrhea, elevated AST, lymphopenia, increased gamma glutamyltransferase, upper respiratory tract infection, increased blood bilirubin, malaise, weight loss, and dizziness.
71.
7% of patients experienced grade three and above adverse reactions, the most common (≥1%) were anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, diarrhea, γ-valley Elevated aminoacyltransferase, hypokalemia, abdominal pain, fatigue, upper respiratory tract infection, pancytopenia, and high blood pressure.
The clinical trials of pamipari include: • The phase 3 clinical trial of pamipari compared with placebo for maintenance treatment of platinum-sensitive patients with recurrent ovarian cancer (NCT03519230) • The use of pamipac in the treatment of patients with ovarian cancer Phase 2 clinical trial in patients with homologous recombination-deficient metastatic castration-resistant prostate cancer (NCT03712930) • Pamida, a phase 2 clinical trial in China for the treatment of patients with metastatic HER2-negative breast cancer with BRCA mutations ( NCT03575065) • Pamipa is used in a phase 2 clinical trial for the treatment of patients with advanced or inoperable gastric cancer (NCT03427814) • Pamipa in China is used for the treatment of advanced ovarian cancer, fallopian tube cancer, primary peritoneal cancer or advanced three Phase 1/2 clinical trial for patients with negative breast cancer (NCT03333915) • Pamidril combined with radiotherapy and/or temozolomide for the treatment of newly diagnosed or relapsed/refractory glioblastoma multiforme patients with phase 1b/2 Clinical trial (NCT03150862) • Phase 1b clinical trial of Pamipali combined with Temozolomide for the treatment of locally advanced or metastatic solid tumors (NCT03150810) • Pamipali combined with Bazin for the treatment of multiple malignant solid tumors 1b Ben Yong, MD, Chief Medical Officer of BeiGene Cancer Immunology, said: “Baihuize® is China’s first PARP approved for the treatment of platinum-sensitive and platinum-resistant patients with recurrent ovarian cancer.
Inhibitors, we are very excited about this. The unique design of Baihuize® is designed to reduce drug resistance and provide continuous anti-tumor remission.
As we announced last year at the European Society of Medical Oncology (ESMO) annual meeting, this highly selective PARP inhibitor can be used in patients It produced a fairly high objective response rate and was generally well tolerated.
We are very grateful to the patients and researchers who participated in the clinical trials, and look forward to Baihuize® becoming an important treatment option for patients with recurrent ovarian cancer in China.
In addition, we are evaluating Baihuize® in a number of other trials and indications, including the ongoing Phase 3 clinical trial of Baihuize® as a maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer.
"Reference source: https://ir.
beigene.
com/static-files/0283ea10-ce41-4c5e-8ddd-5bc55838b9d4
Since more than 60% of ovarian cancer patients are at an advanced stage when they are diagnosed, and about 70% of patients have relapsed due to chemotherapy resistance, the mortality rate of ovarian cancer is generally high.
In China, ovarian cancer is the gynecological cancer with the highest mortality rate, with approximately 22,500 deaths every year.
The five-year survival rate of ovarian cancer patients in China is about 40%.
On May 7, 2021, China National Medical Products Administration (NMPA) conditionally approved Baihuize® for the treatment of advanced ovarian cancer and fallopian tube cancer that have received at least two lines of chemotherapy in the past and carry germline BRCA (gBRCA) mutations Or patients with primary peritoneal cancer.
Full approval for this indication will depend on the results of confirmatory clinical trials in progress.
The Center for Drug Evaluation (CDE) included relevant new drug marketing authorization applications into priority review in July 2020.
BeiGene is preparing for commercialization-related work and is expected to complete the commercial release of Baihui Ze® within this month.
NMPA's conditional approval of Baihuize® for the treatment of patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer is based on the key phase 2 partial clinical results of a phase 1/2 clinical trial (NCT03333915).
Baihuize® (Pamipali) is a PARP1 and PARP2 inhibitor.
Preclinical models have shown that it has pharmacological properties such as penetrating the blood-brain barrier and capturing PARPDNA complexes.
Independently developed by scientists from BeiGene at the Beijing R&D Center, Baihuize® is currently undergoing global clinical development as a monotherapy or in combination with other drugs to treat a variety of malignant solid tumors.
So far, more than 1,200 patients have been enrolled in clinical trials of Baihuize®.
A total of 113 patients with high-grade epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) with gBRCA mutation who have received at least two standard chemotherapy in the past were enrolled in the key phase 2 part of the trial in China, including 90 patients with advanced platinum-sensitive ovarian cancer (PSOC) and 23 patients with advanced platinum-resistant ovarian cancer (PROC).
The effectiveness data of Baihuize® is based on 101 patients with evaluable efficacy and was evaluated by the Independent Review Committee (IRC) according to RECIST v1.
1, including 82 patients with PSOC and 19 patients with PROC.
The median follow-up time for PSOC patients was 17.
0 months, the objective response rate (ORR) was 68.
3% (95% CI: 57.
1, 78.
1), and the median duration of response (DoR) was 13.
8 months (95% CI: 10.
97) , 20.
73); the median follow-up time of PROC patients was 11.
6 months, the ORR was 31.
6% (95%CI: 12.
6, 56.
6), and the median DoR was 11.
1 months (95%CI: 4.
21, 16.
59).
The overall safety profile of Baihuize® is based on 317 patients who received Baihuize® monotherapy in 3 clinical trials.
The most common adverse reactions (≥10%) are anemia, nausea, leukopenia, neutropenia, vomiting, fatigue, thrombocytopenia, loss of appetite, diarrhea, abdominal pain, aspartate aminotransferase (AST) Elevated, elevated alanine aminotransferase (ALT), elevated blood bilirubin, and lymphopenia.
55.
8% of patients experienced grade 3 and above adverse reactions, the most common (≥1%) were anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, fatigue, diarrhea, Nausea and elevated AST.
21.
5% of patients experienced serious adverse reactions, the most common (≥1%) were anemia and leukopenia. The most common adverse reactions (≥10%) reported in this key phase 2 clinical trial in China were anemia, leukopenia, nausea, neutropenia, vomiting, thrombocytopenia, loss of appetite, fatigue, abdominal pain, and elevated ALT.
High, diarrhea, elevated AST, lymphopenia, increased gamma glutamyltransferase, upper respiratory tract infection, increased blood bilirubin, malaise, weight loss, and dizziness.
71.
7% of patients experienced grade three and above adverse reactions, the most common (≥1%) were anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, diarrhea, γ-valley Elevated aminoacyltransferase, hypokalemia, abdominal pain, fatigue, upper respiratory tract infection, pancytopenia, and high blood pressure.
The clinical trials of pamipari include: • The phase 3 clinical trial of pamipari compared with placebo for maintenance treatment of platinum-sensitive patients with recurrent ovarian cancer (NCT03519230) • The use of pamipac in the treatment of patients with ovarian cancer Phase 2 clinical trial in patients with homologous recombination-deficient metastatic castration-resistant prostate cancer (NCT03712930) • Pamida, a phase 2 clinical trial in China for the treatment of patients with metastatic HER2-negative breast cancer with BRCA mutations ( NCT03575065) • Pamipa is used in a phase 2 clinical trial for the treatment of patients with advanced or inoperable gastric cancer (NCT03427814) • Pamipa in China is used for the treatment of advanced ovarian cancer, fallopian tube cancer, primary peritoneal cancer or advanced three Phase 1/2 clinical trial for patients with negative breast cancer (NCT03333915) • Pamidril combined with radiotherapy and/or temozolomide for the treatment of newly diagnosed or relapsed/refractory glioblastoma multiforme patients with phase 1b/2 Clinical trial (NCT03150862) • Phase 1b clinical trial of Pamipali combined with Temozolomide for the treatment of locally advanced or metastatic solid tumors (NCT03150810) • Pamipali combined with Bazin for the treatment of multiple malignant solid tumors 1b Ben Yong, MD, Chief Medical Officer of BeiGene Cancer Immunology, said: “Baihuize® is China’s first PARP approved for the treatment of platinum-sensitive and platinum-resistant patients with recurrent ovarian cancer.
Inhibitors, we are very excited about this. The unique design of Baihuize® is designed to reduce drug resistance and provide continuous anti-tumor remission.
As we announced last year at the European Society of Medical Oncology (ESMO) annual meeting, this highly selective PARP inhibitor can be used in patients It produced a fairly high objective response rate and was generally well tolerated.
We are very grateful to the patients and researchers who participated in the clinical trials, and look forward to Baihuize® becoming an important treatment option for patients with recurrent ovarian cancer in China.
In addition, we are evaluating Baihuize® in a number of other trials and indications, including the ongoing Phase 3 clinical trial of Baihuize® as a maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer.
"Reference source: https://ir.
beigene.
com/static-files/0283ea10-ce41-4c5e-8ddd-5bc55838b9d4
