Overseas Peptide Innovations Deliver Breakthrough Results Amid Surge in TIDES Therapeutics

On 2025-06-02, Hansoh Pharma announced that it had entered into a licensing agreement with Regeneron Pharmaceuticals, Inc., granting Regeneron the exclusive global license (excluding mainland China, Hong Kong, and Macao) to develop, manufacture, and commercialize HS-20094. Under the agreement, Hansoh Pharma will receive an upfront payment of $80 million and is eligible to receive up to $1.93 billion in milestone payments based on the product’s development, regulatory approval, and commercialization progress, as well as double-digit percentage royalties on future potential product sales.

HS-20094 is a GLP-1/GIP dual receptor agonist under research, which has successfully completed multiple Phase II clinical trials with positive efficacy and safety data, and is currently undergoing Phase III clinical trials in China.

2025-06-02, Basel, Switzerland – Novartis announced the interim analysis results of its Phase III clinical trial, PSMAddition. The results showed that Pluvicto™ (177Lu vipivotide tetraxetan) in combination with standard hormonal therapy (ARPI+ADT) achieved a statistically significant and clinically meaningful primary endpoint in radiographic progression-free survival (rPFS) compared to hormonal therapy alone, and demonstrated a positive trend in overall survival (OS).

This study is a randomized, prospective phase III trial that enrolled PSMA-positive mHSPC patients. The primary endpoint is rPFS, and the key secondary endpoint is OS. The control group could crossover to receive Pluvicto treatment after radiographic progression.

Previously, Pluvicto™ had been approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The latest data suggests its potential to expand into the early treatment phase of metastatic hormone-sensitive prostate cancer (mHSPC). Novartis plans to present detailed data at an upcoming medical conference and, based on feedback from the FDA, expects to submit for regulatory review in the second half of this year.

On June 2, 2025, Sapience Therapeutics, a clinical-stage biotechnology company based in New York, USA, announced the latest Phase II clinical data for its first-in-class C/EBPβ antagonist, Lucicebtide (formerly ST101), in the treatment of GBM. The results were presented in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The key highlights of this drug candidate are:

-Clear clinical benefits and good safety

Lucicebtide Monotherapy and Combination with Standard of Care (SOC) Both Show Good Tolerability and Treatment Effects: 1) Newly Diagnosed GBM Patients (n=9): Including 5 patients who have not progressed to date (duration 10–24+ months), and 6 patients still alive (10–26+ months); 2) Recurrent GBM Patients (n=9): Including 4 patients achieving disease control (2 with partial response); 3 patients still alive.

-Biomarker data shows clear mechanism

Lucicebtide successfully penetrates the blood-brain barrier, enters the tumor, and binds to the target, demonstrating: 1) activation of the tumor microenvironment immunity (increased M1/M2 macrophage ratio, enhanced CD8+ T cell infiltration); 2) a significant decrease in the mesenchymal gene signature of tumor cells (spatial transcriptomics analysis results).

Lucicebtide is an innovative peptide drug targeting the transcription factor C/EBPβ. It has completed a Phase II expansion trial for recurrent GBM and is currently conducting a "window period" study in combination with chemoradiotherapy (for newly diagnosed and recurrent GBM). The drug has received Fast Track designation from the FDA and orphan drug designation in both the U.S. and Europe.

Sapience is a clinical-stage company focused on developing peptide therapies that target cancer-driving mechanisms. Its core platforms, SPEARs™ and SPARCs™, are used to target intracellular protein interactions and deliver radiopharmaceuticals to tumor surface receptors, respectively. Lucicebtide and the β-catenin antagonist ST316 have both entered Phase II clinical trials.

On June 3, 2025, according to the Clinicaltrials website, Innovent Biologics registered a Phase 1/2 clinical trial of IBI362 (Mazdutide) for the treatment of moderate to severe obesity. This Phase 1/2 clinical trial plans to enroll 98 patients with moderate to severe obesity and is expected to be preliminarily completed by December 2026. The Phase 1/2 clinical trial uses Tirzepatide as the positive control group, with enrollment criteria set for patients with a BMI ≥ 32.5.

2025-06-03, Vancouver, Canada – NervGen Pharma (TSXV: NGEN, OTCQB: NGENF) announced positive topline results from its Phase 1b/2a clinical trial of NVG-291 for the treatment of chronic cervical spinal cord injury (SCI). The study achieved statistical significance in a pre-specified co-primary endpoint, demonstrating enhanced electrical connectivity between the brain and hand muscles. Positive trends were also observed in the GRASSP score, a secondary endpoint assessing hand function, with particularly strong performance in the "quantitative grasp" subcomponent.

Key Data Highlights:

- Patients treated with NVG-291 showed a threefold increase in motor evoked potential (MEP) amplitude in the first dorsal interosseous muscle of the hand (NVG-291: 6.2→18.8; placebo: 6.5→7.8; p=0.0155).

- The second co-primary endpoint (leg muscle connection) did not reach significance, which was within the expected range.

- GRASSP score increased by 3.7 points (placebo only 0.4 points), although it did not reach statistical significance (p=0.14), 50% of patients in the NVG-291 group improved ≥4 points, much higher than 10% in the placebo group.

-NVG-291 group showed no serious adverse events, with only mild to moderate injection site reactions, and demonstrated good overall tolerability.

NVG-291 is a first-in-class therapeutic peptide molecule that targets the natural repair mechanisms following central nervous system injury. The molecule inhibits CSPGs (chondroitin sulfate proteoglycans)-mediated regenerative suppression signals, particularly by blocking the binding of PTPσ (protein tyrosine phosphatase σ), thereby relieving the inhibition of axonal regeneration; promoting axonal regeneration, neural plasticity, and remyelination; modulating microglia towards a reparative phenotype, reducing inflammatory responses; demonstrating functional recovery effects in animal models of both central nervous system and peripheral nerve injuries.

This molecule originates from the research achievements of Case Western Reserve University in the United States. NervGen holds the global exclusive rights for its development and commercialization and has received Fast Track designation from the FDA.

On 2025-06-05, according to the Clinicaltrials website, Novartis registered a Phase I clinical study (NCT07006727) of [225Ac]Ac-ETN029 for the treatment of patients with advanced DLL3-expressing solid tumors. This is an open-label, multi-center Phase I study, planning to enroll 116 subjects, aiming to evaluate the safety, tolerability, dosage, PK, PD, and preliminary efficacy of [225Ac]Ac-ETN029 in patients with advanced solid tumors expressing DLL3, as well as the safety, dosage, pharmacokinetics, and imaging characteristics of 111In-ETN029.

On 2025-06-05, Jiangsu Hengrui's SHR-3167 Injection was registered for a clinical trial (CTR20252232) in the CTR. This is a clinical study evaluating the efficacy and safety of SHR-3167 Injection and degludec insulin in subjects with type 2 diabetes treated with basal insulin with or without oral hypoglycemic agents. SHR-3167 Injection is a weekly basal insulin formulation independently developed by Hengrui. It has long-acting and stable effects, and is expected to support a once-weekly injection frequency, significantly reducing the number of insulin injections. It is expected to improve patient compliance with insulin therapy, reduce treatment burden, and optimize blood glucose management.

2025-06-05, Nazareth, Israel and Parma, Italy – Elgan Pharma and the Chiesi Group announced that the first preterm infant has been dosed in the global multicenter Phase III clinical trial (FIT-PIV) for their jointly developed investigational drug ELGN-2112. The trial aims to evaluate the safety and efficacy of ELGN-2112 in treating intestinal malabsorption in preterm infants. ELGN-2112 is expected to become the first innovative therapy specifically developed to address intestinal absorption dysfunction in preterm infants.

ELGN-2112 is a recombinant human insulin formulation specifically developed for neonates, designed for enteral delivery, with the following characteristics:

-High solubility, capable of precise low-dose administration;

- Compatible with breast milk, donated milk, and formula;

- Without entering systemic circulation, no systemic insulin exposure;

- Improve the intestinal development and absorption function of premature infants, and accelerate intestinal adaptation;

- Can reduce dependence on intravenous nutrition and lower the risk of complications;

- Insulin naturally exists in amniotic fluid and colostrum and is considered a key "natural tool" in promoting the intestinal maturation of newborns.

On 2025-06-06, Minwe Bio's MWN109 tablets were registered for a clinical trial (CTR20252244) in the CTR. This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and the effect of meal timing following single and multiple oral doses of MWN109 tablets in Chinese study participants. The indications are Type 2 diabetes, overweight, or obesity.

MWN109 Tablets, independently developed by Minwei Biotech, are fatty acid chain-modified peptides with GLP-1/GIP/GCG activity. The product has global intellectual property rights, and its clinical trial application was submitted to the CDE in March 2025. MWN109 Tablets are an oral formulation developed based on MWN109 Injection. The mechanism of action involves stimulating insulin secretion from pancreatic β-cells to effectively control blood glucose levels, delaying gastric emptying and reducing gastric acid secretion to increase satiety and reduce energy intake. Additionally, it promotes fat breakdown, increases energy expenditure and basal metabolism, thereby effectively reducing body weight. Non-clinical studies have shown that MWN109 demonstrates excellent glucose-lowering and weight-reducing activity in both rodents and primates, outperforming the positive control Retatrutide, while exhibiting good safety. MWN109 Tablets overcome the limitations of current subcutaneous injection administration by offering a differentiated oral version, providing patients with a new treatment option while ensuring efficacy.

On June 6, 2025, Stockholm, Sweden – Sobi and Apellis presented open-label period data from the VALIANT Phase 3 clinical study of Aspaveli® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) at the European Renal Association (ERA) Annual Meeting. VALIANT is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that enrolled 124 patients aged 12 years and above. The first 26 weeks of the trial was the blinded period, followed by a 26-week open-label period where all participants received pegcetacoplan. The primary endpoint was the log change in proteinuria (UPCR) from baseline at 26 weeks. The results of this clinical study are as follows:

-Aspaveli reduced proteinuria by 68% at week 26 (compared to placebo), with the effect lasting up to one year;

-The patient's renal function (eGFR) remained stable;

- Patients switching from placebo to Aspaveli also achieved significant improvement in proteinuria and stabilization of renal function;

- Good safety profile, no new adverse reaction signals observed;

-Aspaveli is effective for both primary patients and those with post-transplant recurrence, covering both adolescent and adult populations.

C3G and IC-MPGN are two rare kidney diseases caused by abnormal activation of the complement system, leading to excessive deposition of C3, triggering inflammation and kidney damage. Approximately 50% of patients progress to kidney failure within 5-10 years of diagnosis, and 90% of kidney transplant patients face a risk of recurrence. There are approximately 13,000 patients in Europe and the United States.

Pegcetacoplan is a small-molecule complement inhibitor targeting C3, which has been approved for paroxysmal nocturnal hemoglobinuria (PNH). It is currently expanding its indications to various rare kidney diseases and ophthalmic conditions (including geographic atrophy).

Sobi owns the commercial rights to pegcetacoplan outside the United States, while Apellis is responsible for the U.S. market and global ophthalmic indications.

2025-06-02, Copenhagen, Denmark — Zealand Pharma (NASDAQ: ZEAL), a biotechnology company focused on the development of innovative peptide-based drugs, announced that it has submitted a Marketing Authorization Application (MAA) to the EMA for its investigational drug glepaglutide, intended for the treatment of adult patients with Short Bowel Syndrome (SBS). This submission is based on data from the pivotal Phase III clinical trial EASE-1, supported by interim results from two long-term extension studies (EASE-2 and EASE-3) and a mechanistic study (EASE-4). Zealand expects to initiate the Phase III EASE-5 trial in 2H 2025 to provide additional confirmatory safety and efficacy data for a future FDA submission.

Glepaglutide is a long-acting GLP-2 analog under development that enhances intestinal absorption function and reduces or eliminates the dependence of short bowel syndrome (SBS) patients on parenteral nutrition (PN) through twice-weekly subcutaneous injections. The drug has been granted Orphan Drug Designation by the FDA.

On June 2, 2025, Copenhagen – Ascendis Pharma (NASDAQ: ASND) announced that the FDA has accepted its New Drug Application (NDA) for TransCon CNP (navepegritide) for the treatment of children with achondroplasia, granting it Priority Review. The PDUFA goal date for completion of the review is November 30, 2025. The FDA stated that it does not currently plan to hold an advisory committee meeting.

Clinical Research Highlights:

-Significantly increased annualized height growth velocity (primary endpoint), superior to placebo

- Improvement in multiple nonlinear growth-related indicators: including lower limb alignment, spinal canal dimensions, muscle strength, etc.

-Safety and tolerability comparable to placebo

TransCon CNP is a prodrug of C-type natriuretic peptide (CNP) administered through once-weekly injections, providing sustained CNP exposure that targets systemic tissues, including growth plates and skeletal muscles. By continuously inhibiting the FGFR3 signaling pathway, it improves multi-system disorders caused by abnormal FGFR3 activation.

On June 4, 2025, Qilu Pharmaceutical's Micafungin Sodium for Injection received the marketing approval certificate issued by the NMPA, with the approval numbers H20254375 and H20254376.

On June 4, 2025, Grand Pharma's Pasireotide Aspartate Injection received the marketing approval certificate issued by NMPA, with the approval number H20254400.

2025-06-04, Conjustar Biologics (Xinglian Peptide) announced on May 30 that its EphA2-targeted peptide-drug conjugate (PDC) SC-102 has received FDA Investigational New Drug (IND) approval. The drug will be evaluated for safety and efficacy in patients with advanced or metastatic EphA2-positive solid tumors.

SC-102 had previously received clinical trial approval in China and initiated the trial in August 2024, with the first patient already enrolled. Its counterpart, SC-101, has demonstrated good safety in ongoing studies. SC-101 is an innovative PDC drug capable of specifically binding to tumor cells expressing EphA2, precisely releasing toxins to kill tumors.

2025-06-05, Melbourne, Australia – Telix Pharma (ASX/NASDAQ: TLX) announced that its prostate cancer PET imaging agent Illuccix® (Kit for the preparation of gallium-68 gozetotide injection) has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions, applicable in various clinical scenarios, including:

- Initial staging for high-risk prostate cancer patients;

- Recurrence monitoring when serum PSA increases after radical treatment;

- Identify mCRPC patients suitable for PSMA-targeted therapy.

This approval provides a broad indication label, which will expand the accessibility of PSMA-PET imaging in Germany. PSMA-PET has become the new standard for prostate cancer diagnosis and treatment, surpassing traditional imaging methods such as bone scans and CT, with higher accuracy in disease staging and biochemical recurrence assessment.

Illuccix, supported by clinical data such as the VISION study, is the world's first generator-based GMP-grade PSMA imaging agent that can be prepared on-site in hospitals and clinics, helping to alleviate diagnostic waiting times in Germany caused by a shortage of tracers.