TIDES: Beyond Weight Loss and GLP-1, the Peptide World Is Full of Exciting Developments

On 2025-10-13, Sciwind's Enoxaglutide Tablets received clinical trial approval (CXHL2500742) from the CDE for weight management in individuals with obesity or overweight who have at least one weight-related comorbidity.

On 2025-10-14, the marketing application for Edaglutide α Injection, a Class 1 biologic drug developed by Baike of CSPC Group, was accepted by the CDE (CXSS2500109, CXSS2500110, CXSS2500111).

On 2025-10-14, the clinical application of sodium colistimethate injection from Chengdu Tongde Pharmaceutical was accepted by CDE (CYHL2500180).

Toronto, Canada, October 21, 2025 – Biotech company ProteinQure announced that its self-developed peptide-oligonucleotide conjugation technology successfully achieved efficient delivery of small interfering RNA (siRNA) to the central nervous system (CNS) in non-human primates. The study utilized intrathecal administration and achieved widespread distribution of siRNA in the brain through receptor-mediated transport mechanisms.

In the 28-day study, ProteinQure's conjugated molecules were directly compared to the current clinically leading lipid-based delivery systems, showing best-in-class delivery efficiency and demonstrating superior delivery advantages in specific cell types.

The company will present more early data on its blood-brain barrier crossing technology project at the 21st Annual Meeting of the Oligonucleotide Therapeutics Society (OTS), to be held in Budapest in October 2025.

On October 16, 2025, Jiangsu Pulaite Pharmaceuticals announced the completion of the first participant dosing in the Phase I clinical trial of its Category 1 new drug, antimicrobial peptide PL-3301 oral gel. Safety follow-up for study participants is currently ongoing. This study involves healthy adult participants and is conducting a single-dose escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of the antimicrobial peptide PL-3301 oral gel, providing a basis for subsequent clinical development. The study has received approval from the NMPA and is actively progressing with various clinical research activities.

PL-3301 Antimicrobial Peptide Oral Gel is a novel peptide-based broad-spectrum anti-infective drug, classified as a first-in-class non-antibiotic anti-infective. It features a unique antifungal and antibacterial mechanism of action. Preclinical study data supports its progression into clinical development, aiming to provide a new treatment method for oropharyngeal candidiasis.

Kawasaki, Japan, 2025-10 – PeptiDream Inc. (Tokyo Stock Exchange: 4587) announced that its wholly-owned subsidiary PDRadiopharma has jointly launched a pivotal Phase II clinical trial (jRCT: 2031250225) in Japan with Curium Group, a leader in nuclear medicine, for the PET imaging diagnosis of prostate cancer patients using 64Cu-PSMA-I&T.

64Cu-PSMA-I&T is a copper-64 labeled positron emission tomography (PET) radiopharmaceutical that targets prostate cancer cells expressing prostate-specific membrane antigen (PSMA). The development of this drug is being advanced in parallel with its therapeutic counterpart, 177Lu-PSMA-I&T, together forming a "theranostic radiopharmaceutical companion pair."

This open-label, single-arm Phase II study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T, with plans to recruit approximately 70 patients newly diagnosed with intermediate-, high-, or very-high-risk prostate cancer who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection. The study will be conducted in Japan as a registrational trial and will utilize bridging data from Curium’s global clinical program. Meanwhile, clinical research on 177Lu-PSMA-I&T for the treatment of castration-resistant metastatic prostate cancer (mCRPC) is also being prepared.

Currently, Curium's 177Lu-PSMA-I&T has achieved the primary endpoint in the global Phase III ECLIPSE study (NCT05204927), demonstrating significant clinical benefits; meanwhile, 64Cu-PSMA-I&T has also validated its diagnostic accuracy in multiple international studies (SOLAR series), laying the foundation for its registration in Japan.

On 2025-10-17, the clinical application of Teriparatide Injection from Yunnan Xianshi Pharmaceutical was accepted by CDE (CXHL2501135).

[US & Denmark, 2025-10-17] Novo Nordisk announced that the FDA has approved its oral GLP-1 receptor agonist Rybelsus® (7 mg and 14 mg) for reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes at high risk, including cardiovascular death, myocardial infarction, and stroke. Rybelsus® has thus become the only FDA-approved oral GLP-1 drug with a cardiovascular risk reduction effect, suitable for both primary and secondary prevention of cardiovascular events.

In the Phase IIIb SOUL study, oral semaglutide 14 mg significantly reduced the risk of MACE by 14% (HR=0.86, p=0.006) when added to standard care. Compared with placebo, the incidence rates of cardiovascular events in participants over four years were 12.0% and 13.8%, respectively. The study also showed that the treatment had a good safety profile, with common adverse reactions being mild to moderate gastrointestinal effects.

Currently, Novo Nordisk has submitted a supplemental application in the United States for the once-daily oral version of Wegovy® (semaglutide) for the treatment of obesity, with an approval decision expected within the year.

United States, 2025-10-18 — Pfizer and Astellas today announced the final results of the Phase III EMBARK study: In men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical recurrence (BCR), XTANDI® (enzalutamide) in combination with leuprolide significantly reduced the risk of death and extended overall survival (OS). The results were presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting and simultaneously published in The New England Journal of Medicine.

The study showed that the 8-year survival rate was 78.9% in the XTANDI® plus leuprolide group, compared to 69.5% in the leuprolide-alone group, with combination therapy reducing the risk of death by 40.3% (HR=0.597, 95% CI: 0.444–0.804, p=0.0006). Although XTANDI monotherapy demonstrated a trend toward improved survival, it did not reach statistical significance (HR=0.83, p=0.1867). This makes XTANDI® the first and only androgen receptor inhibitor regimen proven to provide an overall survival benefit in this population.

In the EMBARK study, with a median follow-up of approximately 94 months, the safety profile of the XTANDI combination group was consistent with previous analyses, and no new safety signals were identified. The most common adverse reactions included hot flashes and fatigue. The primary analysis published earlier (in 2023) demonstrated that the combination of XTANDI and leuprolide significantly extended metastasis-free survival (MFS), reducing the risk by 58% compared to leuprolide alone (HR=0.42, p<0.001).

Switzerland, 2025-10-19 — Novartis presented the results of the Phase III PSMAddition study at the Presidential Symposium of the 2025 European Society for Medical Oncology (ESMO) Congress: In patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), Pluvicto™ (177Lu vipivotide tetraxetan) combined with standard treatment (ARPI + ADT) significantly reduced the risk of radiographic progression or death by 28% (HR=0.72, 95% CI: 0.58–0.90) compared to standard treatment alone, and showed a trend toward overall survival (OS) improvement (HR=0.84).

The study also found that the complete remission rate in the Pluvicto group was 57.1% (42.3% in the control group), and the overall response rate (ORR) was 85.3% (80.8% in the control group), significantly delaying disease progression to metastatic castration-resistant prostate cancer (mCRPC) (HR=0.70). The efficacy advantage was consistent across all predefined subgroups.

In terms of safety, the spectrum of adverse events in the Pluvicto group was consistent with previous PSMAfore and VISION studies, with no new safety signals identified. The incidence of grade 3 or higher adverse events was 50.7% (43% in the control group), with the most common being dry mouth, fatigue, nausea, hot flashes, and anemia.

PSMAddition is the third Phase III study of Pluvicto to yield positive results. Following the FDA approval of Pluvicto in March 2025 for mCRPC prior to chemotherapy, this result further demonstrates its potential clinical value in earlier-stage metastatic prostate cancer. Novartis plans to submit a regulatory application by the end of the year, and if approved, it would double the number of potentially eligible patients for Pluvicto.

Hong Kong, 2025-10-19 – Ascletis Pharma (Ascletis, HKEX: 1672) announced that the Phase IIa clinical trial in the United States for its once-monthly subcutaneous injection sustained-release formulation of the small molecule GLP-1 receptor agonist ASC30 (ASC30 SQ depot) has completed full enrollment, with a total of 65 subjects, all of whom are obese or overweight individuals with weight-related comorbidities.

This 12-week randomized, double-blind, placebo-controlled multicenter study aims to evaluate the safety, tolerability, and weight-loss efficacy of ASC30 SQ depot. The study includes three dose groups, with top-line data expected to be released in Q1 2026.

Previously, in the Phase Ib study, ASC30's ultra-long-acting sustained-release formulation demonstrated an observed half-life of 46 days (with a terminal half-life of 36 days) in obese subjects, supporting a once-monthly dosing regimen. Its peak-to-trough concentration ratio was approximately 1.5:1, indicating stable pharmacokinetic characteristics. This formulation is based on Ascletis' proprietary ultra-long-acting sustained-release platform (ULAP), which does not rely on albumin to extend the half-life, thus overcoming the traditional bottleneck where peptide drugs are limited to a half-life of approximately 20 days.

Massachusetts, USA, October 20, 2025 – Apellis Pharmaceuticals (NASDAQ: APLS) announced new data from the open-label phase of the Phase III VALIANT study of its C3 inhibitor EMPAVELI® (pegcetacoplan), demonstrating significant and sustained efficacy in patients with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).

The study results showed that EMPAVELI maintained a significant reduction in proteinuria regardless of whether patients received concomitant immunosuppressive therapy or their baseline proteinuria levels, with an approximately 68% decrease in proteinuria from baseline at one year (p<0.0001). About one-third of patients achieved complete proteinuria remission (UPCR≤0.5 g/g), and the effect persisted for one year. The glomerular filtration rate (eGFR) remained stable, and the safety profile was consistent with previous studies, with no new safety signals identified.

In addition, the results of two indirect comparison analyses based on the Phase III VALIANT study (EMPAVELI) and the APPEAR-C3G study (iptacopan) showed that EMPAVELI was superior to iptacopan in reducing proteinuria and achieving composite renal endpoints, with more patients reaching a ≥50% reduction in proteinuria and a UPCR below 1 g/g.

This result further validates the long-term efficacy and broad applicability of EMPAVELI in C3G and IC-MPGN. As the only currently approved drug for treating C3G and IC-MPGN patients aged 12 years and older, EMPAVELI is expected to significantly improve the quality of life for patients with these rare kidney diseases.

Empaveli (Pegcetacoplan) is an intravitreally injected, PEGylated cyclic peptide therapy targeting the C3 complement protein developed by the company. It specifically binds to complement C3 and its activation fragment C3b, regulating the overactivation of the complement cascade, thereby inhibiting intra- and extravascular hemolysis as well as inflammatory damage.

On 2025-10-22, Hainan Zhonghe Pharmaceutical's semaglutide injection was registered for a clinical trial (CTR20254198) in the CTR. This is a Phase III clinical trial of semaglutide injection for the treatment of obesity.

On 2025-10-22, Hansoh Pharmaceutical registered a clinical trial (CTR20254127) on the CTR for its GLP-1R agonist HS-10501. This is a multicenter, randomized Phase II clinical study to evaluate the efficacy and safety of once-daily oral HS-10501/HS-10501-2 compared to placebo in subjects with type 2 diabetes.

On 2025-10-16, the linaclotide API (registration number: YY20250001041) from Hainan Shuangcheng Pharmaceutical was registered in the CDE’s excipient and packaging material registration system with a status of Inactive.

United States, October 14, 2025 – Kailera Therapeutics, a clinical-stage biopharmaceutical company, announced the completion of a $600 million Series B financing round led by new investor Bain Capital Private Equity. Other new and existing investors, including Adage Capital, Canada Pension Plan Investment Board (CPP Investments), and Janus Henderson, also participated in the round. The proceeds will be used to advance the global clinical development of the company’s differentiated, late-stage obesity treatment pipeline. Following the completion of this financing round, Andrew Kaplan, a partner at Bain Capital, will join the Kailera board of directors.

Funds Focus on Supporting the Global Phase III Clinical Plan for the Company’s Core Candidate Drug, KAI-9531. KAI-9531 is an injectable GLP-1/GIP dual receptor agonist that has demonstrated potentially best-in-class weight loss effects in clinical trials in China. The phase III plan is expected to launch by the end of this year, covering adult patients with obesity or overweight, including those with or without type 2 diabetes, as well as individuals with a BMI ≥35.

In addition, the financing will also drive the oral small molecule GLP-1 receptor agonist KAI-7535 into global clinical trials and support the development of early projects KAI-4729 (GLP-1/GIP/glucagon triple receptor agonist) and KAI-9531 in oral tablet form. The company also holds the rights to new formulations of certain authorized products and the right of first refusal for Hengrui's metabolic disease portfolio.