Hangzhou Ascletis Pharma reported that chronic hepatitis B patients experienced a “functional cure” after being treated with its PD-L1 antibody. In a Phase IIb clinical trial, 42.9% of chronic hepatitis B patients who received ASC22 (envafolimab) ...
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Contents


Ascletis Says PD-L1 Induces “Functional Cure” in CHB Patients

Written by Richard Daverman, PhD.

Hangzhou Ascletis Pharma reported that chronic hepatitis B patients experienced a “functional cure” after being treated with its PD-L1 antibody. In a Phase IIb clinical trial, 42.9% of chronic hepatitis B patients who received ASC22 (envafolimab) experienced a sustained HBsAg loss. In 2019, Ascletis acquired China rights to develop ASC22 for viral diseases from Suzhou Alphamab. The company has also started trials of the PD-L1 for HIV in China and the US. Ascletis’s initial project was Ganovo, an interferon-free therapy for hepatitis C virus, which was approved for China use in 2018. More details....

Stock Symbol: (HK: 1672)

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Clover Bio’s COVID Vaccine Effective as Booster Against Omicron Variants

Written by Richard Daverman, PhD.

Shanghai Clover Biopharma reported its COVID vaccine produced a 19-fold increase in neutralizing antibody levels against the Omicron variant when used as a third-shot booster. Clover used its Trimer-Tag™ platform to develop SCB-2019, a stabilized trimeric form of the S-protein that is based on the original strain of the SARS-CoV-2 virus. It combined the antigen with Dynavax’s CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Clover expects the vaccine will prove to be an effective universal booster for all vaccines. More details....

Stock Symbol: (HK: 02197)

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BeiGene’s Phase III Data Shows PD-1 Effective as First Line Therapy for Esophageal Carcinoma

Written by Richard Daverman, PhD.

Beijing’s BeiGene announced positive results from a global Phase III trial of its PD-1 plus chemotherapy as a therapy for esophageal squamous cell carcinoma (ESCC). Tislelizumab plus chemotherapy increased overall survival to 17.2 months against 10.6 months for chemotherapy alone. The Phase III trial tested tislelizumab as a first-line therapy in patients with advanced or metastatic ESCC. The PD-1 is already approved as a second line ESCC treatment in China. In early 2021, BeiGene out-licensed ex-China rights for the PD-1 to Novartis in a $2.2 billion agreement. More details....

Stock Symbols: (NSDQ: BGNE; HK: 06160; SHA: 688235)

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Suzhou Ascentage to Start US Trial of Novel EED Protein Inhibitor

Written by Richard Daverman, PhD.

Suzhou Ascentage Pharma has been cleared to start US trials of its novel inhibitor of the embryonic ectoderm development (EED) protein, which will be tested in patients with solid tumors or hematologic malignancies. The EED protein can stimulate the methyltransferase activity of EZH2, which promotes the development and progression of tumors. According to Ascentage, APG-5918 is an orally active, potent, selective, small-molecule EED inhibitor with high binding affinity. By regulating tumor epigenetics and microenvironment, the company believes APG-5918 has the potential to overcome tumor resistance and deliver complete and durable tumor regression. More details....

Stock Symbol: (HK: 6855)

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Akeso Approved to Launch Dual Checkpoint Inhibitor for Cervical Cancer

Written by Richard Daverman, PhD.

Hangzhou Akeso announced its PD-1/CTLA-4 bi-specific antibody was approved to launch in China as a second line therapy for relapsed or metastatic cervical cancer (R/M CC) patients who progressed after platinum-based chemotherapy. Globally, cadonilimab injection is first dual immune checkpoint inhibitor bi-specific antibody approved for commercialization. Akeso is continuing to conduct multiple trials of cadonilimab as a first-line therapy for cervical cancer and in solid tumor cancer indications. More details....

Stock Symbol: (HK: 9926)

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Written by Richard Daverman, PhD.


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