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The ovary is where life begins, however, when it becomes cancerous, it becomes the devil that takes the life of a woman! According to the latest statistics, there are 57,000 new cases of ovarian cancer and 27,000 deaths in China every year, such a high mortality rate, which is shocking!
There are 57,000 new cases of ovarian cancer and 27,000 deaths in China every year.Among gynecological malignancies, the incidence of ovarian cancer is second only to cervical cancer and endometrial cancer, but the 5-year survival rate is the lowest among gynecological tumors, only 39%.
Due to the hidden onset of ovarian cancer and the lack of effective clinical early screening methods, about 70% of ovarian cancer patients are found in the advanced stage
.
In addition, the treatment of ovarian cancer has been mainly surgery and chemotherapy, and there has been little major progress
in the past 30 years.
As the first single-agent targeted therapy for ovarian cancer, olaparib marks the era of targeted therapy for advanced ovarian cancer treatment
.
.
Olaparib is an oral polyadenosine diphosphate ribose polymerase (PARP) inhibitor
.
By inhibiting PARP, it reduces or even prevents cancer cells carrying damaged BRCA genes from carrying DNA repair, and kills cancer cells to die
.
About 60% of ovarian cancer patients have DNA homologous recombination defects, of which 20% belong to BRCA1/2 mutations, which is one of
the ideal indications for PARP inhibitors.
The original research of olaparib was jointly developed by AstraZeneca and Merck-MSD under the trade name Lynparza
.
The product was approved by the FDA in 2014 for the treatment of advanced ovarian cancer with BRCA mutation and is the world's first approved PARP inhibitor
.
In China, olaparib is also the first approved new drug
targeted for ovarian cancer.
In 2018, olaparib was approved to enter China under the trade name Lipzo, filling the gap
of nearly 30 years in the field of targeted new drugs for ovarian cancer in China.
In 2019, it was included in the national medical insurance Class B catalogue through negotiation, and the 2021 version of the medical insurance negotiation catalogue restricted the scope of use to include maintenance therapy after first-line platinum-containing chemotherapy after achieving complete or partial remission in advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer-naïve adult patients with germline or somatic BRCA mutations (gBRCAm or sBRCAm); Patients with
platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
In addition, in September this year, the list of drugs that passed the preliminary review of the adjustment of the national medical insurance catalogue in 2022 was announced, and olaparib tablets may have new indications to participate in follow-up medical insurance negotiations
.
of nearly 30 years in the field of targeted new drugs for ovarian cancer in China.
In 2019, it was included in the national medical insurance category B catalogue through negotiation
Since the launch of olaparib, with the continuous expansion of indications and the gradual increase in approved regions, its sales have soared, and it has been
little affected by latecomers.
It is reported that its global sales exceeded $3 billion in 2021, which is a well-deserved blockbuster drug
.
According to data from Minai.
com, after Olapali entered medical insurance, the sales of public hospital terminals (urban public hospitals + county-level public hospitals) grew rapidly, while the retail pharmacy terminals remained stable, and the public primary medical terminal market was yet to be developed
.
In 2021, the total sales of this product in the six major markets of the three major terminals exceeded 1 billion yuan
.
This year has also maintained a high-speed growth trend, and the market prospects are considerable
.
.
This year has also maintained a high-speed growth trend, and the market prospects are considerable
.
Olaparib's situation in the domestic market (: million yuan)
(Source: Minainet Database)
At present, olaparib is the exclusive variety of AstraZeneca, and no other generic drugs have been approved for marketing
in China.
And olaparib's compound patent expires in March 2024, the preparation patent expires in October 2029, and the purpose patent expires in November 2024
.
in China.
According to the statistics of Yao Rongyun, there are currently many domestic pharmaceutical companies participating in the first generic competition, namely Qilu Pharmaceutical (the first to report production), Shanghai Xuantai Pharmaceutical Science and Technology| Jiangsu Xuantai Pharmaceutical, Hunan Kelun Pharmaceutical, Shiyi Ouyi, and Sino-US East
China.
In addition, pharmaceutical companies such as Chongqing Yaoyou Pharmaceutical, Jiangxi Shanxiang Pharmaceutical and Nanjing Fangsheng He Pharmaceutical have also carried out BE trials
of olaparib.
The dispute over the first generic drug in China has become increasingly fierce
.
Domestic olaparib imitation application listing overview
(Source: WuRong Cloud China Drug Evaluation Database)