Semaglutide Approved for Weight Management in China; Multiple Biopharma Companies Announce Clinical and Regulatory Milestones

丨National Science 2023Science and Technology Progress Award Announced

On June 24, the 2023 National Science and Technology Awards were announced in Beijing. A total of 250 projects were selected for the three major awards, including 49 National Natural Science Awards (1 first prize and 48 second prizes), 62 National Technology Invention Awards (8 first prizes and 54 second prizes), and 139 National Science and Technology Progress Awards (3 special prizes, 16 first prizes, and 120 second prizes). To meet the strategic needs of the country, a number of landmark achievements have been made in the fields of transportation, electronics and information, advanced manufacturing, medical and health, agriculture, etc., among which 32 projects and 1 innovation team in the medical and health field were awarded.

Multiple projects related to biopharmaceutical innovation have stood out. These projects cover various aspects including circular RNA research, cell fate regulation, T-cell immune mechanisms, inflammation and cancer transformation, translational medicine research in hematology, discovery and application of extracellular small RNAs, research on new subpopulations of immune cells, and the development of vaccines for hand, foot, and mouth disease. (Science and Technology Daily)

丨NMPA Seeks Opinions on Further Optimizing the Review and Approval Process for Overseas Drugs Already on the Market That Are Urgently Needed in Clinical Settings

On June 25, to expedite the approval and market entry in China of clinically urgent drugs already approved overseas, meeting the pressing clinical needs of patients, the National Medical Products Administration (NMPA) drafted the "Announcement of the National Medical Products Administration on Further Optimizing the Review and Approval Procedures for Clinically Urgent Drugs Already Approved Overseas (Draft for Public Comment)" and is now soliciting public opinions. (NMPA)

丨Hengrui Pharma Announces Phase 2 Clinical Data for Bispecific Antibody Therapy

On June 24, Hengrui Pharma announced that the results of its proof-of-concept Phase 2 clinical study (TRAILBLAZE study) evaluating SHR-1701, a PD-L1/TGF-βRII bispecific antibody developed in-house, administered as neoadjuvant therapy with or without chemotherapy for unresectable stage III non-small cell lung cancer (NSCLC), were officially published in full online by the prestigious international academic journal Cancer Cell. SHR-1701 is a novel bifunctional fusion protein targeting PD-L1 and TGF-β, currently undergoing Phase 3 clinical trials for gastric cancer, perioperative treatment of gastric cancer, and first-line treatment of cervical cancer. Researchers conducted a proof-of-concept trial to evaluate neoadjuvant SHR-1701 with or without chemotherapy, followed by surgery or radiotherapy outcomes in untreated unresectable stage III NSCLC. The researchers concluded that neoadjuvant SHR-1701 combined with chemotherapy (followed by surgery or radiotherapy) demonstrated promising efficacy and tolerable safety in patients with unresectable stage III non-small cell lung cancer. Surgical conversion was feasible in a significant proportion of patients (1/4) and associated with better survival outcomes. (Hengrui Pharma)

丨SANEGENEBIO's RNAi Therapy Approved for Clinical Trials

On June 24, the CDE website announced that SANEGENEBIO's Class 1 new drug SGB-9768 injection received implied permission for clinical trials. It is intended to be developed for the treatment of complement-mediated kidney diseases, including adult IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. According to publicly available data from SANEGENEBIO, this is an RNAi drug targeting complement C3 protein, which has previously been approved in New Zealand to conduct Phase 1 clinical studies. As introduced in SANEGENEBIO’s press release, SGB-9768 is a siRNA-GalNAc conjugate targeting complement C3. It utilizes the company's innovative technology to deliver into liver cells and inhibits the synthesis of hepatic C3 through RNAi. Preclinical research data shows that this product can effectively and continuously reduce C3 synthesis. The safety, efficacy, and stability of GalNAc-delivered siRNA drugs have been verified by substantial data. Additionally, SGB-9768 allows for dosing once every three or six months, offering advantages such as low treatment frequency, good patient compliance, and long-lasting efficacy. (SANEGENEBIO)

丨SIMM's Self-Developed Anti-Tumor New Drug Glumetinib Approved for Marketing in Japan

On June 24, Japan's Ministry of Health, Labour and Welfare approved the targeted c-Met kinase inhibitor Glumetinib tablets (R&D code: SCC244) for marketing in Japan to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations. The drug was further developed by Shanghai Haihe Biopharma Co., Ltd., which holds global independent intellectual property rights. Glumetinib is the first innovative drug independently researched and developed by Chinese scientists and a Chinese biopharmaceutical company to be approved for marketing in Japan, marking another significant achievement for China's innovative drugs going global. Due to its significant clinical efficacy and dual advantages of safety and tolerability, Glumetinib was granted conditional marketing approval as a breakthrough therapy drug by China’s National Medical Products Administration (NMPA) in March 2023 and was awarded orphan drug designation by the U.S. Food and Drug Administration (FDA).

丨Semaglutide Approved for Weight Loss Indication in China

On June 25, the NMPA approved the listing application in China for Novo Nordisk's Wegovy (semaglutide injection for long-term weight management). As the world’s first and currently only glucagon-like peptide-1 receptor agonist (GLP-1RA) weekly formulation for long-term weight management, Wegovy can achieve an average weight loss of 17% (16.8kg) and provide patients with multiple health benefits beyond weight reduction, with its safety widely validated. The approval of this innovative drug will offer a breakthrough health weight management solution for patients with overweight and obesity (initial BMI greater than or equal to 30kg/m²; or between 27kg/m² and 30kg/m² with at least one weight-related comorbidity), ushering in a new era of obesity treatment in China through scientific, effective, and safe means. (Novo Nordisk)

丨Johnson & Johnson's Talique Approved in China

On June 25, Johnson & Johnson announced that its innovative therapeutic drug Talique (Tetrisotuzumab Injection) has been officially approved by the NMPA as a monotherapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody). Talique is the first bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3 to be approved for the treatment of RRMM, and it has previously been approved for marketing in countries or regions such as the United States and the European Union. (Johnson & Johnson)

丨Ivy Pharma's Novel Class 1 Drug for Dry Eye Disease Initiates Phase 1/2 Clinical Trial in the U.S.

On June 25, Aiviva Pharma announced that the clinical trial of its Class 1 innovative drug IVW-1001 for the treatment of dry eye disease has been initiated in the United States, with the first subject dosed. According to Aiviva Pharma's press release, IVW-1001 is a novel TRPM8 cold receptor agonist designed to treat the signs and symptoms of dry eye disease. This is the first-in-human (FIH) clinical trial of IVW-1001 launched in the U.S., which will be conducted across more than 10 clinical centers in the country. The trial aims to rigorously evaluate the safety, tolerability, and efficacy of IVW-1001. (Aiviva Pharma)

丨Merck's Pembrolizumab Approved for New Indication in China

On June 25, the NMPA website announced that MSD's anti-PD-1 monoclonal antibody pembrolizumab had received approval for another new indication. According to MSD's press release, the approved indication for this drug is: in combination with trastuzumab, fluoropyrimidine-based, and platinum-based chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS≥1) as assessed by a validated test. So far, the number of indications for pembrolizumab approved in China has reached 14. In May 2021, pembrolizumab received accelerated approval in the United States, in combination with trastuzumab, fluoropyrimidine, and platinum-based chemotherapy for the first-line treatment of patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. (MSD)

丨AstraZeneca's Key Lung Cancer Drug Osimertinib Receives Approval for New Indication in China

On June 25, the NMPA official website announced that the new indication marketing application for AstraZeneca's osimertinib mesylate tablets has been approved. Osimertinib (osimertinib), developed by AstraZeneca, is an irreversible third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is reported that the newly approved indication for this drug is first-line treatment in combination with chemotherapy for EGFR-mutated advanced non-small cell lung cancer (NSCLC). Osimertinib, a key lung cancer treatment drug under AstraZeneca, has demonstrated confirmed clinical efficacy in non-small cell lung cancer patients. Currently, osimertinib has been approved as a monotherapy in more than 100 countries and regions, including the United States, the European Union, China, and Japan. Approved indications include first-line treatment for patients with locally advanced or metastatic EGFRm non-small cell lung cancer, second-line treatment for patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer, and adjuvant treatment for early-stage EGFRm non-small cell lung cancer. (AstraZeneca)

丨Stone Pharma's First Cell Therapy Approved for Clinical Trials

On June 25, CSPC Pharmaceutical Group announced that its mRNA-LNP-based chimeric antigen receptor (CAR)-T cell injection, SYS6020, had received implied permission for clinical trials in China. It is being developed to treat relapsed or refractory multiple myeloma. This marks the first significant achievement in CSPC's strategic efforts in the cell therapy field. SYS6020 is an mRNA-LNP-based cell therapy product. By expressing a CAR that specifically recognizes the BCMA antigen, it targets and eliminates BCMA-positive cells within patients, achieving therapeutic effects. Compared with traditional CAR-T products, SYS6020 boasts advantages such as high cell viability, high CAR positivity rate, no risk of tumorigenicity caused by genomic integration, and reduced side effects like cytokine release syndrome (CRS). Preclinical studies have shown that this product can significantly kill BCMA-positive myeloma cells while demonstrating favorable safety and efficacy. (CSPC Pharmaceutical Group)

丨Bi-XDC Product of Tongyi Pharma Granted Third Orphan Drug Designation by FDA

On June 26, Tongyi Pharma announced that the U.S. FDA had granted orphan drug designation to its self-developed second-generation bispecific ligand conjugate (Bi-XDC) CBP-1019 for the treatment of small cell lung cancer (SCLC). To date, CBP-1019 has received three orphan drug designations from the FDA, for the treatment of pancreatic cancer, esophageal cancer, and small cell lung cancer respectively. CBP-1019 is a second-generation Bi-XDC technology product developed by Tongyi Pharma. The drug design employs dual ligands FRα/TRPV6 carrying a next-generation camptothecin derivative payload, representing further innovation and optimization based on the Bi-XDC drug CBP-1008. According to preclinical study data, CBP-1019 has demonstrated tumor-inhibiting effects across various cancers, including gynecological tumors, lung cancer, pancreatic cancer, and colorectal cancer. Currently, CBP-1019 has initiated a Phase 1/2 international multicenter clinical trial. As of April 2024, CBP-1019 has reached the 4.0 mg/kg dose cohort, showing good safety and preliminary efficacy. (Tongyi Pharma)

丨Novo Nordisk's Oral Dual Agonist Approved for Clinical Trials in China

On June 26, the CDE website announced that Novo Nordisk's Class 1 new drug, amycretin tablets, has been approved for clinical trials, intended for reducing the weight of overweight or obese adult patients. Public information shows that this is a long-acting co-agonist of oral GLP-1 receptor and amylin receptor developed by Novo Nordisk, representing a new generation of weight-loss therapy. In a small Phase 1 clinical study previously published by Novo Nordisk, patients who received treatment with this product for 12 weeks experienced a weight reduction of 13.1% (vs 1.1% in the placebo group), demonstrating rapid weight loss effects and good clinical application potential. Amylin is a hormone related to hunger and satiety, separate from the GLP-1 signaling pathway. Studies have shown that amylin can reduce energy intake, regulate food choices and preferences, exert glucose regulation together with insulin, inhibit postprandial glucagon release, and delay gastric emptying. Additionally, the amylin receptor is expected to synergize with GLP-1 receptor agonists.(Novo Nordisk)

「Long Press」Add Xiaoda via QR code「Join the group」

Explore Market Frontiers with More Industry Partners