Baiji Shenzhou Small Molecular Innovative Drug Global Industrialization Base Launched in Suzhou
六月清晨搅
发表于 2023-11-17 13:14:13
234
0
0
Shanghai Securities News China Securities Network News (Reporter Zhang Xue): The reporter learned from Baekje Shenzhou that on November 16th, the Baekje Shenzhou Small Molecule Innovative Drug Global Industrialization Base was completed and officially opened in Suzhou, Jiangsu Province.
It is reported that the newly completed industrial base has a construction area of nearly 50000 square meters and is expected to produce up to 1 billion solid formulations per capsule annually. The base has a commercial scale and flexible production capacity for clinical medication, which can quickly achieve high-quality transformation of large and small molecule independent research and development pipelines from laboratory to clinical product production and then to commercial production. It provides production support for the continuously growing product pipeline of small and medium-sized molecule commercial drugs and large and small molecule clinical candidate drugs. It is currently one of the few integrated bases in the world that can achieve the industrialization of new drugs.
At the beginning of the construction of the Suzhou base, advanced design concepts were introduced, strictly following the cGMP (current drug production quality management standards) of China, the United States, and the European Union, and establishing an internationally leading quality management system to meet the quality requirements of global supply of products, including Zebutinib. Zebutinib is the first independently developed anticancer drug in Chinese pharmaceutical history to be approved by the US Food and Drug Administration (FDA). It has been launched in over 65 markets worldwide, providing treatment and services to patients.
In September of this year, the Suzhou base in Baekje China passed the cGMP on-site inspection by the US FDA, marking that the Zebutinib produced by the Suzhou base has officially obtained the qualification for commercial supply to the US market. It also proves that the sustainability and high maturity of the quality system of the Suzhou base in Baekje China have been internationally recognized.
Since settling in the Suzhou Industrial Park in 2015, the Baiji Shenzhou Suzhou Base has established a clinical and commercial scale production capacity for small molecule drugs, as well as a production capacity for large molecule clinical raw materials; The Suzhou Pharmaceutical Research and Development Center of Baekje Shenzhou is also under construction.
Ou Leiqiang, co-founder, chairman and CEO of Baekje Shenzhou, stated that the opening of the Suzhou Innovative Drug Global Industrialization Base is of great significance to Baekje Shenzhou - it not only enhances Baekje Shenzhou's independent commercial production capacity, but also further strengthens the company's small molecule research and development capabilities in the later stage. Baekje will continue to invest and work together with partners to save the lives of more patients in China and even around the world.
CandyLake.com 系信息发布平台,仅提供信息存储空间服务。
声明:该文观点仅代表作者本人,本文不代表CandyLake.com立场,且不构成建议,请谨慎对待。
声明:该文观点仅代表作者本人,本文不代表CandyLake.com立场,且不构成建议,请谨慎对待。
猜你喜欢
- Baekje Shenzhou PD-1 has been approved by FDA as the second product in China after Junshi Biotechnology
- After a series of twists and turns, the core product of Baekje Shenzhou, Baekze An, has become the second domestically produced PD-1 approved in the United States
- BeiGene: Net profit for 2023 is approximately -6.716 billion yuan
- BeiGene: Chief Financial Officer Wang Aijun will resign on July 19th
- Company Review | BeiGene has suffered continuous losses in the past 7 years, and its stock price is under pressure. Can the new CFO bring a turning point?
- More than 40% reduction in losses in the first half of the year, but multiple peers have achieved profits. BeiGene is facing increasing peer pressure
- AbbVie sues for infringement again, BeiGene denies allegations: this move is intended to prevent project development
- Domestic innovative drug leader faces another 'patent challenge': AbbVie accuses BTK degradation agent of infringement, causing BeiGene's stock price to suffer a setback
- BeiGene denies AbbVie's accusation of "stealing trade secrets": will launch a firm defense and development projects will not be interrupted as a result
- BeiGene responds to AbbVie's lawsuit alleging theft of trade secrets: with the intention of obstructing the development process
-
9月が終わり、映画・テレビ業界が暗躍している。最近、愛奇芸の創始者でCEOのGONG宇氏は、映画・テレビ業界が長短の変化、AIの変化、中国映画・テレビドラマの海外進出の変化の3つの変化を経験していると発表した。 ...
- 寒郁轩良
- 前天 14:17
- 支持
- 反对
- 回复
- 收藏
-
10月1日、理想自動車が9月に納入したデータによると、9月に理想自動車が新車53709台を納入し、前年同月比48.9%増となった。 今年第3四半期、理想自動車は前年同期比45.4%増の152831台を納入した。今年9月30日現在、 ...
- 就放荡不羁就h
- 11 分钟前
- 支持
- 反对
- 回复
- 收藏
-
ネットワーク状況監視サイトDownDetectorによると、オーディオストリーミングプラットフォームSpotifyは日曜日に約3時間にわたる障害を経験した後、正常に回復し、ピーク時には米国の4万人以上のユーザーに影響を与 ...
- hecgdge4
- 前天 09:33
- 支持
- 反对
- 回复
- 收藏
-
百済神州(688235.SH)はA株の有名な革新薬企業で、2017-2024年上半期、同社の各期の研究開発投資はA株の化学製薬会社(申万二級)の中で最も高く、研究開発費用は合計600億元を超えた。 しかし、百済神州にとって ...
- wylz8473
- 3 天前
- 支持
- 反对
- 回复
- 收藏