Johnson & Johnson's Oral Peptide Icotrokinra Demonstrates Significant Efficacy in Scalp and Genital Plaque Psoriasis in Phase III ICONIC-TOTAL Trial

On 2025-05-06, Lilly's small-molecule oral GLP-1RA drug Orforglipron capsules received clinical tacit approval from the CDE, with the indication for treating hypertension in adult patients with obesity or overweight. Orforglipron is an investigational, once-daily oral small molecule (non-peptide) GLP-1 RA. The drug can be taken at any time of the day without dietary or hydration restrictions. Orforglipron was discovered by Chugai Pharma and licensed to Lilly for development in 2018, with both parties jointly publishing preclinical pharmacological data on this molecule. Currently, Lilly is conducting Phase 3 studies of Orforglipron for the treatment of type 2 diabetes and for weight management in overweight adults with at least one weight-related comorbidity or obesity. Additionally, Lilly is investigating Orforglipron as a potential therapy for obstructive sleep apnea and hypertension in obese adults.

2025-05-06, Hansoh Pharma's oral GLP-1 receptor agonist HS-10501 was registered for a clinical trial in CTR (CTR20251769). This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of once-daily oral HS-10501/HS-10501-2 in overweight and obese subjects. HS-10501 is an oral GLP-1 receptor agonist with unique features in its mode of administration and mechanism of action, potentially offering patients more treatment options.

2025-05-06, AstraZeneca's AZD6234 registered a clinical trial (CTR20251720) on the CTR platform. This is a clinical study evaluating the safety, tolerability, pharmacokinetics, and efficacy of AZD6234, AZD9550, and the combination of AZD6234 with AZD9550. The indication is for long-term weight management in overweight or obese adults with at least one obesity-related comorbidity. This molecule is a long-acting amylin receptor agonist and CALCR receptor agonist that plays a role in regulating blood glucose and energy balance. It is clinically developed for the treatment of obesity, showing significant weight loss after a single dose compared to all doses of placebo.

On 2025-05-06, Yichang Humanwell's Angiotensin II Injection received clinical tacit approval from the CDE for the treatment of adult patients with septic shock or other distributive shock requiring vasopressor therapy.

On 2025-05-08, Chongqing Bofeng Microspheres' Leuprolide Acetate Microspheres for Injection received clinical tacit approval from the CDE.

On 2025-05-08, Shengdi Pharmaceutical's HRS-7535 tablets were registered for a clinical trial (CTR20251779) in the CTR. This trial aims to evaluate the pharmacokinetics and safety of HRS-7535 in subjects with hepatic impairment and those with normal liver function. HRS-7535 tablets are a novel oral small-molecule GLP-1RA, which can promote insulin secretion and reduce glucagon secretion in the pancreas by activating human GLP-1 receptors and inhibit gastric emptying. It can also enhance satiety and suppress appetite by influencing the central nervous system, directly reducing energy intake, thus making it useful for treating type 2 diabetes and weight loss.

On 2025-05-09, HDM1005 Injection from Hangzhou Zhongmei Huadong registered a clinical trial (CTR20251762) in the CTR. This trial is a clinical study assessing the mass balance of HDM1005 in Chinese healthy subjects. The indications are for weight management in people with type 2 diabetes, overweight or obesity. HDM1005 Injection is a new class 1 chemical drug independently developed by Zhongmei Huadong, which owns global intellectual property rights. It is a dual-target long-acting agonist of peptide human GLP-1 receptor and GIP receptor. Preclinical studies have shown that HDM1005 can promote the production of cyclic adenosine monophosphate (cAMP), increase insulin secretion, suppress appetite, delay gastric emptying, and improve metabolic function by activating GLP-1 receptor and GIP receptor, thereby improving plasma volume, reducing oxidative stress and systemic inflammation, and enhancing cardiovascular adaptability. It has effects on lowering blood sugar, reducing weight, and improving MASH and heart failure with preserved ejection fraction (HFpEF). Meanwhile, existing data show that HDM1005 has good druggability and safety.

2025-05-09, MWN109 tablets developed by Minwei Biologics received clinical tacit approval from the CDE for use in overweight or obesity. MWN109 is a fatty acid chain-modified peptide with GLP-1/GIP/GCG activity. The tablet is an oral formulation developed based on the MWN109 injection, and its mechanism of action involves stimulating insulin secretion by pancreatic β-cells to control blood glucose, regulating gastric emptying and gastric acid secretion to increase satiety and reduce energy intake. It also promotes fat breakdown, increases energy expenditure and basal metabolism, thereby reducing body weight.

2025-05-09, Johnson & Johnson announced the Phase III clinical trial (ICONIC-TOTAL) data of its innovative oral peptide drug icotrokinra (JNJ-2113). This drug is the first oral targeted therapy that selectively blocks the IL-23 receptor, intended for patients with moderate to severe plaque psoriasis, especially cases affecting high-burden areas such as the scalp, genitals, hands, and feet.

At Week 16 of the trial: 1) 66% of patients with scalp psoriasis achieved "clear or almost clear" scalp lesions (ss-IGA score 0/1) after using icotrokinra, significantly higher than the 11% in the placebo group (P<0.001); 2) 77% of patients with genital psoriasis reached the same clearance criteria (sPGA-G score 0/1), compared to 21% in the placebo group (P<0.001); 3) In patients with palmoplantar psoriasis, the clearance rate was 42%, also higher than the 26% in the placebo group. Overall, 57% of patients receiving icotrokinra achieved the primary endpoint: IGA score of 0/1 and improvement of at least two grades from baseline, compared to only 6% in the placebo group (P<0.001). In terms of safety, icotrokinra performed well: the incidence of adverse events was similar (50% vs 42%), severe adverse events were lower (0.5% vs 1.9%), with no new safety signals detected.

Icotrokinra is an orally administered small-molecule peptide drug (oral peptide) and the first orally available therapeutic candidate that selectively targets the IL-23 receptor (IL-23R). It was jointly discovered and developed by Protagonist Therapeutics and Janssen Biotech, stemming from a licensing and collaboration agreement between the two companies in 2017. Protagonist Therapeutics focuses on leveraging its proprietary peptide drug discovery platform to develop novel oral peptide molecules. Through this platform, scientists identified a class of orally deliverable peptides with high affinity and targeted specificity. Icotrokinra has been optimized to exhibit picomolar affinity for IL-23R, effectively and selectively inhibiting the IL-23 signaling pathway.

This medication has demonstrated significant efficacy in treating psoriasis on sensitive and difficult-to-treat areas such as the scalp and genitals, offering patients a new once-daily oral option that aligns with their medication preferences, which may potentially alter the current treatment landscape.

2025-05-11, Lilly announced the results of the SURMOUNT-5 Phase III clinical trial: Over a 72-week period, Zepbound (tirzepatide) significantly outperformed Wegovy (semaglutide) across all primary and key secondary endpoints for the treatment of obesity or overweight individuals with metabolic-related conditions.

1) Primary endpoint:

- Average weight loss: Zepbound results in 47% more weight reduction

-Zepbound: Weight loss of 20.2% (22.8 kg)

-Wegovy: Weight loss of 13.7% (15.0 kg)

2) Achievement Rate of Key Secondary Endpoints (Zepbound vs. Wegovy):

-≥10% Weight Loss: 81.6% vs. 60.5%

-≥15% Weight Loss: 64.6% vs. 40.1%

-≥20% Weight Loss: 48.4% vs. 27.3%

-≥25% Weight Loss: 31.6% vs. 16.1%

- Waist circumference reduction: 18.4 cm vs. 13.0 cm

3) Safety:

- The adverse reactions are mainly gastrointestinal symptoms, usually mild to moderate.

- Discontinuation Rate: Zepbound 6.1%, Wegovy 8.0%.

- This study did not make a direct comparison of the safety of the two drugs.

On May 9, 2025, Nanjing Kangzhou Pharmaceutical's Cetrorelix Acetate for Injection received the marketing approval certificate issued by the NMPA, with the approval number H20254056.

On May 9, 2025, Suzhou Landing Bio's Recombinant Human Brain Natriuretic Peptide for Injection received the marketing approval certificate issued by NMPA, with the approval number S20250019.