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CSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO., LTD.

石药集团明复乐药业(广州)有限公司

CSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO., LTD. (formerly known as "Guangzhou Recomgen Biotech Co., Ltd.") was founded in Guangzhou in 2000, is an innovative biopharmaceutical company focusing on the large-scale serum-free continuous animal cell culture technology and the R&D of new biologicl drugs. In 2022, it was merged into CSPC Pharmaceutical Group Limited (stock code: 1093). In the future, the company will follow the strategic planning of the Group and continue to enrich macromolecule product pipelines, to become an important basis of CSPC in the Greater Bay Area of China.

rhTNK-tPA, the latest generation specific thrombolytic drug dependently developed by the company, was approved in 2015, filling the gap in this field in China. As the Significant New drugs Creation Project during 12th Five-Year plan and the only third-generation rhTNK t-PA product in China, rhTNK-tPA is the only drug that can be injected intravenously in a single dose, which is conventient and suitable for emergency treatment and out-of-hospital thrombolysis as needed. It will enhance the treatment rate, improve the clinical benefit as well as reduce the personal and societal medical burdens in terms of patients with acute myocardial infarction received thrombolytic therapy.

The Phase III clinical trial of rhTNK-tPA for the treatment of acute ischemic stroke (AIS) has completed the enrollment of patients. This research is aimed to improve the accessibility of the drug and save more lives of stroke patients, and reduce the disability rate. We look forward to fill the gap of the third-generation thrombolytic drugs in treating ischemic stroke worldwide.

With the mission of Social responsibility on shoulders, Human health in heart, we will continuously focus on technological innovation and drug quality, aiming to build the world's top brand of thrombolytic therapy and becoming a leading biopharmaceutical company globally.

Development History
  • founded in Guangzhou

  • obtained the IND approval of three recombiant protein products including rhTNK-tPA

  • initiated the registrational clinical trial of rhTNK-tPA, with Fuwai Hospital as the lead hospital

  • started the building of manufacture plant

  • finished the clinical trial of rhTNK-tPA for the treatment of acute myocardial infarction (AMI)

  • submitted the NDA of rhTNK-tPA to CDE

  • completed the construction of GMP manufacture plant

  • rhTNK-tPA was approved by NMPA

  • started the clinical trial of rhTNK-tPA for AIS, with Beijing Tiantan Hospital as the lead hospital
  • finished the Phase II clinical trial of rhTNK-tPA for acute ischemic stroke and initiated the Phase III clinical trial
  • rhTNK-tPA was included in the National Medical Insurance Catalogue (NRDL)
  • merged into CSPC and renamed as CSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO., LTD.
Enterprise Culture
  • Our mission

    Social responsibility on shoulders, Human health in heart

  • Our spirit

    Generous, Dedicated, Persevering, Aspiring

  • Our vision

    To build a top brand of thrombolytic therapy, to be a leading enterprise in biopharmacy

  • Our values

    Aspiring and Persevering

Be sincere

We know very well,
Only like-minded people can accumulate strength;
Only with sincerity at heart can we achieve win-win cooperation;
Only by gathering collective intelligence can we move forward with excellence.
We firmly believe that,
April showers bring May flowers!
We, with our vision, are practicing our common mission:
To build the first international brand of thrombolysis,
Achieve excellent biopharmaceutical companies!

Social Responsibility
We promise:

Safety and sustainability have always been a priority in what we do. We place a high value on our corporate social and environmental responsibility.

We believe in creating value for society by continuously innovating scientific solutions to develop medicines that meet future needs.

We provide a safe workplace for our employees, care about their lives and encourage a positive work environment together.

We sincerely hope that all employees will continue to grow and progress.

We comply with regulations and ethics and operate with integrity, which are the basic principles of our business everywhere.

We want to achieve "zero accidents",aiming to eliminate accidents at work, reduce emissions and water consumption, avoid waste, and improve safety and sustainability.