November Highlights: Key Events in the Peptide Drug Sector

Obesity / Metabolic Diseases

Novo Nordisk:

Intensive data release:

Oral semaglutide 25mg (Wegovy) ^® Oral formulation: A follow-up analysis of the OASIS 4 Phase III trial showed that, within 64 weeks, 71.1% of pre-diabetic patients achieved normal blood glucose levels (compared to 33.3% in the placebo group). Pre-menopausal, perimenopausal, and post-menopausal women experienced an average weight reduction of 15% to 18.2%. Among patients with poor physical fitness, 77.3% reported improved physical performance. The adverse events were predominantly mild to moderate gastrointestinal reactions.

Wegovy ^® 7.2 mg high dose: The STEP UP Phase III b analysis showed an average weight loss of 21%, and 19.5% of patients achieved “BMI < 27 + waist-to-height ratio < 0.53.” Among those who met the criteria, cardiovascular risk indicators returned to healthy levels. This drug is currently being submitted for approval to the EMA and the UK regulatory authorities.

CagriSema (cagrilintide + semaglutide): A post-hoc analysis of the REDEFINE 1 Phase III trial showed that, after 68 weeks of treatment, systolic blood pressure decreased by 10.9 mmHg—outperforming semaglutide alone, which resulted in a reduction of 8.8 mmHg. High-sensitivity C-reactive protein (hsCRP) levels dropped by 68.9%, and 40% of hypertensive patients were able to discontinue antihypertensive medications.

Eli Lilly: Phase 2 data for eloralintide have been published in The Lancet. Among 263 obese or overweight patients, the 9-mg dose group achieved an average weight loss of 20.1% over 48 weeks (compared to 0.4% in the placebo group). The drug demonstrated a favorable safety profile, and a combination trial with tirzepatide is being concurrently advanced (NCT06603571).

Merck:

Oral PCSK9 inhibitor enlisertide achieves major success in Phase III trials:

CORALreef HeFH Trial: After 24 weeks, LDL-C was reduced by 59.4%; 67.3% of patients achieved the target level of “LDL-C < 55 mg/dL with a reduction of ≥50%”; efficacy persisted over 1 year.

CORALreef Lipids Trial: In the primary analysis over 24 weeks, LDL-C was reduced by 55.8% (59.7% in the reanalysis); 67.5% of patients achieved target levels. The safety profile was comparable to that of the placebo, and this agent holds promise as the first oral PCSK9 inhibitor.

Altimmune: Pemvidutide (a GC/GLP-1 dual agonist) Phase IIb IMPACT study’s pathological analysis showed that in the 1.8 mg group, 31% of MASH patients experienced a ≥60% reduction in liver fibrosis area (compared to 8% in the placebo group), accompanied by concurrent improvements in non-invasive biomarkers. The RECLAIM Phase II study (for AUD treatment) has completed enrollment of 100 patients ahead of schedule, and results are expected to be released in 2026.

Palatin Technologies:

MC4R agonist pipeline gains momentum:

PL7737 (oral): Dose-dependent weight loss in DIO mice, with oral bioavailability of 50%. Granted FDA Orphan Drug Designation for LEPR-deficient obesity. IND submission planned for H1 2026.

BMT-801 Phase II: The MC4R agonist in combination with tirzepatide leads to greater weight loss than tirzepatide alone and also helps prevent weight regain.

Rivus Pharmaceuticals: Preclinical data for oral CMA-class RV201 show that, as a monotherapy, it leads to a 16% reduction in body weight and a 46% reduction in body fat. When combined with semaglutide, it results in a 25% reduction in body weight and a 63% reduction in body fat, while preserving muscle mass and boosting basal metabolic rate.

Aion Medicines: The ultra-long-acting GLP-1RA prodrug AM-710 has a half-life of 76–91 days in mice—150 times longer than that of orally administered orforglipron. A single injection of AM-710 led to weight loss of more than 15% in obese mice within one month, demonstrating an efficacy surpassing that of daily injections of semaglutide.

Biomea Fusion: BMF-650 (an oral GLP-1RA) achieved a 12-15% weight reduction in obese crab-eating monkeys, with an oral bioavailability of 54%—higher than that of orforglipron. Phase I initial data are expected to be released in H1 2026. The menin inhibitor in combination with a low-dose semaglutide reduced fasting blood glucose by 60% and HbA1c by more than 2% in diabetic rats; clinical trials are set to begin in Q4 2025.

Hengrui Medicine: HRS9531 (a GLP-1/GIP dual agonist) Phase III trial (GEMINI-1) showed that in the 6 mg group, the average weight loss over 48 weeks was 19.2% (with 44.4% of patients experiencing a weight loss of ≥20%). The trial also demonstrated improvements in cardio-metabolic parameters, and an NMPA marketing application has been submitted. Kailera plans to initiate its global Phase III trial by the end of 2025.

Gilead Sciences:

Release multi-lineage data

ASC30: The oral formulation showed a maximum weight loss of 9.3% in the 28-day Multiple Ascending Dose (MAD) cohort at 60 mg; the injectable formulation has the longest half-life of 75 days, supporting quarterly dosing.

ASC31 + ASC47 combination: DIO mice experienced a 44.8% weight reduction (significantly exceeding the 19.1% achieved with ASC31 alone and the 20.4% achieved with tirzepatide), while lean body mass was preserved.

ASC36 (an amyloid peptide receptor agonist) has been selected as a clinical candidate. Its half-life in NHPs is 15 days—three times that of petrelintide—and it is expected to submit an FDA IND application in Q2 2026.

Ganlee Pharmaceutical: The first dose of GZR18, a biweekly GLP-1RA formulation (GZR18), has been administered in the GRADUAL-2 Phase III trial (a head-to-head comparison with semaglutide). The trial is planned to enroll 471 patients with obesity or overweight, with the primary endpoint being the percentage change in body weight at 52 weeks.

QL Biopharm: The oral GLP-1 peptide tablet ZT006 has initiated Phase II clinical trials (CTR20254183) to evaluate its efficacy, safety, and pharmacokinetics in subjects with overweight or obesity.

Inflammatory/Immune Diseases

Protagonist (in collaboration with Johnson & Johnson):

Oral IL-23 receptor antagonist icotrokinra

ANTHEM-UC Phase 2b: Among UC patients treated for 28 weeks, 31.7% achieved clinical remission and 38.1% showed endoscopic improvement (superior to placebo), supporting the advancement to Phase 3 in CD.

ICONIC-TOTAL Phase 3: In patients with scalp psoriasis, 72% achieved “clear or nearly clear” skin; 85% showed improvement in the genital area; the overall clearance rate remained at 67% after 52 weeks, with no new safety signals identified.

A new trial, CTR20254293, has been added to evaluate the efficacy in moderate-to-severe active Crohn’s disease.

Yicheng Kangtai: The clinical application for Ipiu peptide powder (a targeted anti-inflammatory drug that precisely inhibits p55PIK) has been accepted by the CDE (CXHL2501206).

Tumor

ITM Isotope Technologies: In the subgroup analysis of the Phase III COMPETE study, the radiolabeled peptide 177Lu-edotreotide (ITM-11) demonstrated a median progression-free survival (PFS) of 23.9 months in Grade 1/2 SSTR-positive gastrointestinal and pancreatic neuroendocrine tumors (GEP-NETs)—compared to 14.1 months with everolimus. The objective response rate (ORR) was 21.9% (versus 4.2% with everolimus). Notably, patients with Grade 2 tumors showed a significant prolongation of PFS (21.7 vs. 9.2 months). Dosimetric data indicated an average tumor absorbed dose of 110.0 Gy, while exposure of the kidneys and red bone marrow remained well below safety thresholds, clearly highlighting the safety advantage of this treatment.

PeptiDream: In collaboration with Curium, we have initiated a registration-directed Phase II clinical trial in Japan evaluating 64Cu-PSMA-I&T for PET diagnosis of prostate cancer. At the same time, we are simultaneously advancing the development of the therapeutic companion drug 177Lu-PSMA-I&T, thereby establishing a “diagnosis-and-treatment integrated” radioligand peptide combination. Previously, the global Phase III ECLIPSE study had already demonstrated the clinical benefits of 177Lu-PSMA-I&T.

Lebo Richen: The peptide-drug conjugate (PDC) RAB001 has received acceptance of its clinical application from the CDE for the treatment of osteonecrosis. It is a globally first-in-class drug that targets mesenchymal stem cells (MSCs) to promote osteogenic differentiation, improve bone blood supply, and reduce inflammation, thereby achieving bone regeneration.

Other

Eli Lilly: Brenipatide injection has received implicit clinical approval from the CDE, with indications for the treatment of alcohol use disorder in adults and the treatment of tobacco use disorder in adults (to reduce the risk of relapse after smoking cessation in adults). This molecule is a dual-target GLP-1/GIP receptor agonist.

Ascendis Pharma: A 3-year pooled analysis of the long-acting PTH drug TransCon PTH (for the treatment of hypoparathyroidism) showed that 70.3% of patients experienced an increase in eGFR of ≥5 mL/min/1.73 m², 91% of patients became free from dependence on active vitamin D, and 24-hour urinary calcium excretion returned to normal.

Chongqing Paijin Bio: The clinical application for the recombinant acylated glucagon-like peptide-2 analog for injection has been accepted by the CDE (CXSL2500952).

Neurogastrx: Phase II studies of NG101 (a peripherally selective dopamine D2 receptor antagonist) showed that it could reduce the incidence of GLP-1RA-associated nausea by 40%, decrease vomiting by 67%, shorten the duration of symptoms, and demonstrate good tolerability.

1. Acceptance of the listing application

Fosun Wanbang: Four marketing applications for semaglutide injection have been accepted by the CDE (CXSS2500119/120/121/122).

Novartis: The marketing application for Lutetium [177Lu] Tc-68Peptide Injection has been accepted by the CDE (JXHS2500125).

Nanjing Haina Pharmaceutical: The marketing application for Cyclosporine Eye Drops (III) has been accepted by the CDE (CYHS2503803).

2. Clinical Application / Implied Approval

Clinical application acceptance:

Changchun JinSai: Leuprolide Acetate Injection Emulsion (CYHL2500148);

Shandong Shengdi Pharmaceutical: HRS-7535 Tablets (Multiple Indications);

Hengrui Medicine: Leuprolide Acetate Microspheres for Injection (CYHL2500159, for prostate cancer);

Novo Nordisk: CagriSema Injection (multiple indications).

Clinical Implied Consent:

Nanjing Zhengke Pharmaceutical & Yangtze River Pharmaceutical: Polymyxin E Sodium for Injection (CYHL2500139, indicated for Gram-negative bacterial infections);

Qilu Pharmaceutical: Semaglutide Injection (for long-term weight management in adults).

3. Review Extension

Rhythm Pharmaceuticals: The review period for the supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) in the treatment of acquired hypothalamic obesity has been extended by 3 months (PDUFA date now set for March 20, 2026), due to the FDA’s request for additional efficacy sensitivity analyses—this extension is unrelated to safety or manufacturing concerns.

1. Investment and M&A: A Ten-Billion-Yuan Bid Reshapes the Obesity Market Landscape

Pfizer Acquires Metsera: After multiple rounds of bidding, Pfizer defeated Novo Nordisk with a total consideration of approximately $10 billion (US$65.60 in cash per share plus up to US$20.65 in CVRs), acquiring the cutting-edge obesity treatment company Metsera and making a strong move into the obesity market—expected to exceed US$150 billion in size by 2030. Following its withdrawal from the deal, Novo Nordisk stated that it will now focus on its own metabolic pipeline.

2. Strategic Cooperation: Complementary Technologies, Expanding Pipeline Applications

Lisata Therapeutics: Signed a global licensing agreement with Catalent, granting it the right to use certepetide on the SMARTag® ADC platform; and formed an alliance with GATC Health to explore new indications for certepetide using a multi-omics AI platform.

Amphastar: In collaboration with Nanjing Anji Bio, we are advancing three innovative peptide-based drugs, including an endogenous anti-cancer peptide, a peptide-docetaxel conjugate, and a VEGFR-targeting peptide eye drop (for the treatment of wet AMD).

3. Financial Report Disclosure: Cash reserves are ample, and pipeline progress is clear.

Lisata Therapeutics: The Q3 2025 financial report shows that the company has approximately $19 million in cash (sufficient to fund operations through Q1 2027). The company is prioritizing clinical development of programs such as ASCEND (pancreatic cancer) and BOLSTER (biliary tract cancer), and will release the final results of the ASCEND trial in Q1 2026.

Amphastar: The Q3 2025 financial report shows net revenue of $191.8 million (flat year-on-year), with net profit reaching $17.4 million. Sales of BAQSIMI® totaled $53.6 million (up 33% year-on-year), while sales of the glucagon generic drug amounted to $13.5 million (down 49% year-on-year). Three ANDAs and one insulin biosimilar are currently under FDA review, and three biosimilars and two complex generic drugs are in development.

Protagonist Therapeutics: The Q3 2025 financial report shows cash and cash equivalents of $679 million (sufficient to support operations through the end of 2028). Icotrokinra has submitted a marketing application to the EMA for psoriasis, and rusfertide (for the treatment of PV) is expected to submit its NDA in Q4 2025. PN-881 (an oral IL-17 antagonist) has completed dosing of the first subject in Phase I clinical trials, and PN-477 (a triple agonist) is advancing pre-IND studies.

4. Commercial Marketing: Policy Collaboration to Enhance Drug Accessibility

Eli Lilly & Novo Nordisk: Reach Agreement with U.S. Government to Lower Obesity Drug Prices Starting in 2026—Medicare beneficiaries can obtain Zepbound (Eli Lilly) and Wegovy® (Novo Nordisk) for a monthly out-of-pocket cost of just $50. Eli Lilly will include drugs such as Orforglipron and Trulicity in the LillyDirect discount program, offering patients who pay out-of-pocket discounts of 50% to 60%. Meanwhile, Novo Nordisk will expand access to Wegovy through a Medicare Part D pilot program. ^® /Ozempic ^® Coverage.

CongenPharma specializes in the research, development, and production of peptides and small-molecule drugs. We are committed to providing customers with high-quality peptide products and solutions, and we are determined to make sustainable and affordable peptides accessible to everyone, contributing to human beauty and health.

CongenPharma establishes EMPHASES. ^® The new liquid-phase peptide synthesis platform replaces traditional solid-phase resins with liquid-phase carriers, thereby increasing reaction speed, shortening reaction time, and enhancing synthesis efficiency. It also reduces the usage of amino acids, coupling reagents, and solvents, minimizes the generation of three wastes, and effectively controls costs. The platform has already been granted eight patents in China, the U.S., and Japan.

Core business:

① Providing innovative process and quality research services for pharmaceutical peptides (including tirzepatide and semaglutide);

② Supply GLP-1 industrial chain products with both quality and price advantages: side chains, short peptides, oral enhancers, etc.:

③ Fragments of peptides such as Tirzepatide and Retatrutide, which have supply advantages…