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News and Trends 20 Jul 2023

Endometrial cancer drug receives breakthrough therapy designation in China

HUTCHMED (China) Limited has announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to the combination of fruquintinib and sintilimab (a PD-1 antibody) for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed at least one line of platinum-based […]

July 20, 2023 - 4 minutesmins - By Jim Cornall

In Depth 19 Jul 2023

Genetic engineering giants: is China poised to lead the way?

For many people, when they hear China and genetic engineering in the same sentence, it is often synonymous with scandal, and gene-edited babies may spring to mind. And, although it is true that nearly five years ago, researcher He Jiankui infamously claimed he had created the first ever gene-edited babies, before going to prison for […]

July 19, 2023 - 7 minutesmins - By Willow Shah-Neville

News and Trends 31 Mar 2023

Ablaze Pharmaceuticals to develop first-in-class therapy for liver cancer in China

Ablaze Pharmaceuticals, a biotech company focused on developing targeted radiotherapy (TRT) to benefit cancer patients in China, is developing plans for a first-in-class novel peptide drug candidate against GPC3. The proprietary GPC3-targeting peptide is being licensed from RayzeBio. Upon in-license of product candidates by Ablaze from RayzeBio, Ablaze will be responsible for clinical development and […]

March 31, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 17 Mar 2023

Likang gets trial ok for China’s first personalized cancer vaccine

Likang Life Sciences has received implied approval for the clinical trial of its personalized neoantigen-targeted vaccine for advanced solid tumors, LK101 injection. This is the first personalized neoantigen vaccine and mRNA editing product approved by China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to enter the clinical stage. Likang submitted […]

March 17, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 17 Feb 2023

Report: China leads the way with phase 1 studies

Novotech, an Asia Pacific biotech CRO, has published a new global report on phase 1 trial activity including current metrics on fast growth regions and therapeutic areas. The data analysis found that Asia Pacific has been the fastest-growing region for phase 1 clinical trials in the last 10 years, reaching a share of 58% in […]

February 17, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 9 Jan 2023

Cartherics granted first patent in China

Cartherics Pty Ltd, a biotechnology company developing immune cell therapies for the treatment of cancer, has been granted a Chinese patent, “Genetically modified cells and uses thereof.” The patent provides a proprietary position for multiple development candidates in Cartherics’ pipeline. Specifically, it covers Cartherics’ chimeric antigen receptor (CAR) targeting tumor-associated glycoprotein-72 (TAG-72), along with T […]

January 9, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 3 Jan 2023

Legend Biotech new drug application approved in China

Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its new drug application (NDA) for ciltacabtagene autoleucel (cilta-cel). This submission is based on data from the confirmatory phase 2 clinical study CARTIFAN-1, conducted in China, which evaluated the efficacy and safety of cilta-cel in adult patients with relapsed or […]

January 3, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 19 Dec 2022

Jacobio’s cancer treatment given breakthrough therapy designations by China CDE

Jacobio Pharma’s in-house KRAS G12C inhibitor JAB-21822 has been granted breakthrough therapy designations in China. The designations are for the second line and above treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation. The designations were granted by the Center for Drug Evaluation (CDE) of the National Medical Products […]

December 19, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 14 Nov 2022

Nuance Pharma’s RSV vaccine cleared for trial in China

Nuance Pharma says China’s Center for Drug Evaluation (CDE) has approved its investigational new drug (IND) application supporting its pivotal phase III clinical trial of MVA-BN RSV vaccine against respiratory syncytial virus (RSV) in adults in China. MVA-BN RSV is being developed for the prevention of RSV in older adults. The vaccine incorporates five distinct RSV […]

November 14, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 14 Nov 2022

HUTCHMED announces positive gastric cancer study results in China

HUTCHMED (China) Limited has announced initial results from FRUTIGA, a phase III study of fruquintinib combined with paclitaxel in 703 Chinese patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The trial was positive, having met one of the primary endpoints of statistically significant improvement in progression-free survival (PFS), which is clinically meaningful. The other […]

November 14, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 8 Sep 2022

First patient dosed in China trial with drug to treat non-Hodgkin lymphoma

The dosing of the first patient at a clinical trial in China for patients with relapsed/refractory non-Hodgkin lymphoma (NHL) was announced yesterday (September 7). CASI Pharmaceuticals and BioInvent International AB are running the phase 1, dose-escalation and expansion study of BI-1206. The treatment is a fully human monoclonal antibody (mAb) that targets FcyRIIB, in combination […]

September 8, 2022 - 2 minutesmins - By Liza Laws

News and Trends 5 Sep 2022

Astellas ‘encouraged’ by menopause symptom treatment results in China

Astellas Pharma Inc. has announced topline results from its phase 3 MOONLIGHT 3 clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night […]

September 5, 2022 - 4 minutesmins - By Jim Cornall

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