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Latest KeyMed Biosciences News
Sep 22, 2022
China CDE Grants CMG901 Breakthrough Therapy Designation for Claudin 18.2-Positive Advanced Gastric & Gastroesophageal Junction Cancer Share: CHENGDU, China, Sept. 22, 2022 /PRNewswire/ -- Keymed Biosciences (HKEX:02162) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted CMG901 the Breakthrough Therapy Designation for the treatment of advanced gastric and gastroesophageal junction(GEJ) cancer which have relapsed and/or are intolerant to prior therapies. About CMG901 CMG901 is a Claudin 18.2-targeted antibody-drug conjugate (ADC) developed for the treatment of Claudin 18.2-expressing solid tumors. In April 2022, the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation[i] and Orphan Drug Designation[ii] as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancer which are resistant/refractory to prior therapies. About CDE's Breakthrough Therapy Designation CDE's Breakthrough Therapy Designation is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, BTD provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later. For additional information, please visit website: http://en.keymedbio.com/ Reference [i] FDA granted CMG901 fast track designation for unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies. News release. Keymed Biosciences. April 19, 2022. Accessed September 12, 2022. https://prn.to/3jXET0G [ii] CMG901 for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma was granted the orphan-drug designation by the Food and Drug Administration of the United States. News release. Keymed Biosciences. April 12, 2022. Accessed September 12, 2022. https://prn.to/3vGqR9o
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KeyMed Biosciences Frequently Asked Questions (FAQ)
When was KeyMed Biosciences founded?
KeyMed Biosciences was founded in 2016.
Where is KeyMed Biosciences's headquarters?
KeyMed Biosciences's headquarters is located at Building D2, Chengdu.
What is KeyMed Biosciences's latest funding round?
KeyMed Biosciences's latest funding round is IPO.
How much did KeyMed Biosciences raise?
KeyMed Biosciences raised a total of $84.3M.
Who are the investors of KeyMed Biosciences?
Investors of KeyMed Biosciences include Hankang Equity Investment Management and Legend Star.
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