Pharma Frontiers: Daily Digest of Global Pharmaceutical News – Jul 9

1.Ascentage Pharma's Olverembatinib Approved for Marketing in Macau, China

On July 8, Ascentage Pharma announced that olverembatinib has officially been approved by the Macau Special Administrative Region’s Institute for the Supervision and Administration of Pharmaceuticals (ISAF) for marketing. The approved indications include: treatment of chronic myeloid leukemia (CML) in chronic phase (-CP) and accelerated phase (-AP) in adult patients who are resistant to any tyrosine kinase inhibitor (TKI) and possess the T315I mutation; and treatment of CML-CP in adult patients who are resistant and/or intolerant to first- and second-generation TKIs. Olverembatinib, being the first and only third-generation BCR-ABL inhibitor approved for marketing in our country, is undeniably significant. The development of this medication primarily addresses the resistance challenges faced by previous generations of inhibitors, particularly against various drug-resistant BCR-ABL mutations including the T315I mutation. The research and development of olverembatinib have focused on expanding its inhibitory spectrum against BCR-ABL mutations, thereby enhancing therapeutic effectiveness. According to current published research results, olverembatinib has achieved several key clinical evidences. Overall, these findings indicate that olverembatinib demonstrates significant therapeutic efficacy in treating CML patients, further supporting its use as an effective option for CML treatment.

2.Haisco Approved for Market Release of Crisugabalin Capsules for Specific Indications

On July 8th, Haisco announced that it had recently received a "Drug Registration Certificate" for the Class 1 innovative drug Crisugabalin Capsules from the National Medical Products Administration. This product, independently developed by Haisco with proprietary intellectual property rights, is an oral γ-aminobutyric acid (GABA) analog. It interacts with voltage-sensitive calcium channel α2δ receptors in the central nervous system, reducing the influx of calcium ions through voltage-dependent calcium channels. This mechanism decreases the release of excitatory neurotransmitters such as glutamate, noradrenaline (NE), and substance P, exhibiting analgesic, antiepileptic, and anti-anxiety activities. Prior to this, the product was first approved in May 2024 for the indication of "adult diabetic peripheral neuropathic pain." The newly approved indication is "for the treatment of adult diabetic peripheral neuropathic pain and postherpetic neuralgia." Compared to other drugs targeting the same receptor, Crisugabalin Capsules provide superior target binding dissociation activity, expected improved analgesic efficacy, and do not require titration during administration. Overall, its safety profile is good and controllable, making it a potentially preferred treatment for adult diabetic peripheral neuropathic pain and postherpetic neuralgia, benefiting a broader population of patients.

3.Zhikang Hongyi Biological's highly selective ETA antagonist successfully met the primary endpoint in its Phase 2 clinical trial

On July 8, Zhikang Hongyi Biological announced that its clinical Phase 2 study of the highly selective endothelin receptor A (ETA) antagonist SC0062, one of its core pipeline products, achieved its primary endpoint in a Phase 2, 2-SUCCEED trial for IgA Nephropathy (IgAN) in patients with chronic kidney disease (CKD) exhibiting proteinuria. The trial results demonstrated that SC0062 significantly reduced proteinuria compared to the placebo group, displaying a clear dose-response relationship, with clinically and statistically significant outcomes. SC0062 showed good safety, with no adverse reactions like sodium and water retention observed in patients treated with SC0062. Furthermore, the combination use of SC0062 with SGLT2 inhibitors as a standard treatment exhibited good safety in the study as well. These latest results will be presented at an upcoming international medical conference. SC0062 is a novel molecule designed specifically for chronic kidney disease, functioning as a highly selective endothelin receptor A (ETA) antagonist that can improve renal blood flow, reduce proteinuria, and alleviate inflammatory and fibrotic processes. The development of SC0062 aims to enhance drug safety, such as reducing adverse reactions like sodium and water retention, which is associated with blocking the endothelin receptor B (ETB). The 2-SUCCEED trial is an ongoing multicenter, randomized, double-blind, placebo-controlled, dose-ranging exploration, Phase 2 clinical trial designed in two cohorts (IgA nephropathy and diabetic nephropathy) to assess the efficacy and safety of SC0062 capsules in patients with proteinuric chronic kidney disease.

4.Tonghua Dongbao initiates Phase Ib clinical trial for GLP-1R/GIPR agonist as a weight loss treatment

Tonghua Dongbao has recently initiated a Phase Ib clinical trial (CTR20242389) for its GLP-1R/GIPR dual agonist, THDBH120, as recorded on the Clinical Trials Registration and Information Disclosure Platform. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of THDBH120 in obese participants in China with repeated administration. The primary endpoints of this Phase Ib clinical study include the incidence and severity of adverse events (AEs), assessed per NCI-CTCAE (version 5.0) at Day 78, including symptoms, laboratory findings, vital signs, physical examination, 12-lead ECG, hypoglycemia, and injection site reactions. Secondary endpoints include pharmacokinetic (PK) parameters post-multiple subcutaneous administrations, pharmacodynamic (PD) parameters, and the percentage of participants developing anti-drug antibodies along with the titers of these antibodies.

THDBH120 is a dual-target agonist for the glucagon-like peptide-1 (GLP-1) receptor and the glucose-dependent insulinotropic polypeptide (GIP) receptor, integrating the insulin-potentiating effects of both GLP-1 and GIP into a single peptide molecule. It also aims to enhance metabolic stability and improve glycemic control through further molecular design, potentially fulfilling clinical needs unmet by single molecule or combination therapies for diabetic patients, and it hopes to be a blockbuster drug for longer-lasting diabetes management.

Among its peers, Eli Lilly’s dual GIP and GLP-1 receptor agonist Tirzepatide has been launched in the United States, Europe, Japan, and China, prescribed alongside diet control and exercise to improve glycemic control in adults with type 2 diabetes. In November 2023, the FDA approved a new indication for Tirzepatide for the treatment of obesity.

5.Vision Biological's Novel EGFR Inhibitor Approved by China's NMPA for Phase 1/2 Clinical Trials

On July 8, Vision Biological Pharmaceuticals announced that China's National Medical Products Administration (NMPA) has approved its novel EGFR inhibitor, WSD0922, for a phase 1 bridging and phase 2 expansion clinical trial in China. This trial is aimed at patients with advanced/metastatic non-small cell lung cancer (NSCLC) with C797S mutation progressing after first-line treatment with third-generation EGFR inhibitors. According to a press release from Vision Biological Pharmaceuticals, WSD0922 is a proprietary fourth-generation EGFR/EGFRvIII-targeted inhibitor with the potential to penetrate the blood-brain barrier. It is intended to be developed for use against central nervous system (CNS) metastases and brain tumors associated with NSCLC. The drug has the potential to overcome resistance mechanisms of various first-line third-generation EGFR inhibitors and may treat EGFRvIII-driven glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA). WSD0922 has demonstrated favorable pharmacokinetics and safety in completed phase 1 dose escalation and ongoing expansion cohorts at Mayo Clinic, particularly in NSCLC patients with CNS metastases and recurrent brain gliomas post Osimertinib (Osimertinib) treatment, including those with C797S mutations and EGFRvIII-positive recurrent brain gliomas. The phase 1/2 clinical trials in China will lay the groundwork for China to join an international multicenter phase 2 trial already approved by the U.S. FDA, which uses WSD0922 for advanced/metastatic NSCLC with C797S mutation progressing on first-line Osimertinib. The anticipation is that WSD0922 will soon address the unmet clinical needs associated with resistance to first-line third-generation EGFR inhibitors characterized by the C797S mutation.

6.Ovid Therapeutics Announces Phase 1 Clinical Trial Data for OV888/GV101 Capsules

Recently, Ovid Therapeutics, in collaboration with Graviton Bioscience, announced the safety, tolerability, and pharmacokinetic results of their OV888/GV101 capsules from a Phase 1 clinical trial conducted in healthy volunteers. The OV888/GV101 capsule is a highly selective and potent inhibitor of ROCK2. Proper regulation of the ROCK2 pathway has been proven essential for endothelial function in blood vessels, as abnormal activation of this pathway is a critical component in the pathogenesis of central nervous system diseases, including hemorrhages and the formation of brain and spinal cord lesions. Preclinical studies have shown that the OV888/GV101 capsules can cross the blood-brain barrier and are highly selective for ROCK2. The Phase 1 study achieved its objectives, demonstrating good safety and tolerability of the OV888/GV101 capsules with no serious adverse events reported. Secondary endpoint results indicated that at the targeted clinical dosage, the OV888/GV101 capsules achieved the desired pharmacokinetic profile, supporting once-daily dosing. Additionally, the OV888/GV101 capsules exhibited biological activity in subjects and produced dose-dependent pharmacodynamic effects within the planned therapeutic dose range. Ovid and Graviton plan to initiate a Phase 2 clinical study in patients with cerebral cavernous malformations later this year.

7.Hinova Pharmaceuticals' small molecule anti-tumor new drug has been approved for clinical trials in the United States

On July 7, Hinova Pharmaceuticals announced FDA approval of the Phase 1/2 clinical trial application for HP537 tablet intended for the treatment of hematological malignancies. Previously, the application for clinical trials of HP537 in China was approved by China's NMPA in February 2024. HP537 is a small molecule antitumor drug developed independently by Hinova Pharmaceuticals, functioning as a p300/CBP inhibitor. p300/CBP is involved in cell cycle progression and cell growth, differentiation, and development, and is highly expressed and activated in tumors, acting as a key regulatory factor for tumor cell growth. The HP537 tablet works by binding to the bromodomain (BRD) of p300/CBP, blocking the p300/CBP signaling pathway and inhibiting the enzymatic activity of p300/CBP, thereby suppressing the growth of tumor cells. This product is primarily intended for the treatment of hematological malignancies, including but not limited to multiple myeloma, non-Hodgkin's lymphoma, acute myeloid leukemia, and myelodysplastic syndromes. Results from preclinical studies on HP537 were featured in the Late-Breaking Research session at the 2024 AACR Annual Meeting held in April. Preclinical studies indicated that HP537 exhibits good efficacy and safety with high activity, high selectivity, and favorable oral bioavailability.

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