250813 [Pharma Analysis] 16 Phase 3 Trials in July… Oncogenic Therapeutics & GNT Pharma Pursue Phase 3 for Expanded Indicat

17 Cancer-Targeted Trials Mostly Focused on Solid Tumors; 11 Phase 2 (2/3), 9 Phase 1 (1/2), 2 Investigator-Initiated Trials Approved

In July, the number of clinical trial approvals for domestic biopharmaceuticals and innovative new drugs approached 40, intensifying the competition in drug development.

According to an analysis by the Pharmaceutical News on July 12 of the Ministry of Food and Drug Safety’s Integrated Drug Information System and the Korea Biopharmaceutical Association data, a total of 38 INDs (Investigational New Drug applications) for biopharmaceuticals and notable new drugs (first-in-class or new modality) were approved in July.

By clinical trial phase, Phase 3 approvals were the most numerous at 16, followed by Phase 2 (2/3) with 11, and Phase 1 (1/2) with 9. Two investigator-initiated trials were also approved.

Among the approvals, 17 trials targeted cancer treatments, with all but one focusing on solid tumors. Indications included osteosarcoma, non-small cell lung cancer, small cell lung cancer, breast cancer, colorectal cancer, hepatocellular carcinoma, and head and neck squamous cell carcinoma. In June, nearly half of all approved trials (16) were also oncology-focused.

Of the 12 companies receiving Phase 3 IND approval, many were CROs and multinational pharmaceutical firms. Domestic companies included Onconic Therapeutics and GNT Pharma, both receiving Phase 3 approvals.

Other companies granted Phase 3 approvals included Roche Korea, Novartis Korea, Parexel Korea (CRO), Portia Korea (CRO), MSD Korea, IQVIA Korea (CRO), AbbVie Korea, ICON Clinical Research Korea (CRO), PPD Development PTY LTD, BeiGene Korea, and Servier Korea. IQVIA Korea and AbbVie Korea each received approval for two trials.

A total of nine domestic companies received IND approvals in July. In addition to GNT Pharma and Onconic Therapeutics, the list included CureCell, Cyrus Therapeutics, Bionox, Bichedam, Celltrion, Pluto, and Bilix. The approvals span startups, listed biotechs, and large biopharmaceutical companies.

Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, is pursuing an indication expansion for Korea’s 37th new drug, ‘Jacuvoze (JP-1366)’. The company received Phase 3 approval to add the non-erosive reflux disease (NERD) indication. Jacuvoze already holds indications for erosive reflux disease and gastric ulcers, making it a multi-indication therapy eligible for monotherapy prescriptions.

The Phase 3 trial involves approximately 31 sites, including Severance Hospital, with 321 patients. The study will last about 24 months, aiming to demonstrate superiority over placebo in relieving heartburn symptoms, with an expected completion date in June 2027.

Jacuvoze has achieved rapid market expansion. According to the pharmaceutical market research firm UBIST, cumulative prescriptions exceeded 10 billion KRW within six months of launch. In Q4 of last year, prescriptions totaled around 3.3 billion KRW, and approximately 6.7 billion KRW in Q1 of this year.

GNT Pharma is also expanding the indication for ‘Nellonemdaz’. The company received MFDS approval for Phase 3 IND of Nellonemdaz, a dual-action neuroprotective agent that selectively inhibits NR2B NMDA receptors and provides strong antioxidant effects to prevent acute and spreading neuronal death. GNT Pharma aims to address the limitations of reperfusion therapy and reduce disability and mortality, targeting global market entry with this novel treatment.

The Phase 3 trial involves 378 patients with severe ischemic stroke eligible for thrombectomy within 12 hours of onset. The first dose is administered within 60 minutes of ER arrival, repeated 10 times over 5 days. Patients’ independence in daily living will be evaluated 12 weeks post-treatment. Prior domestic trials showed up to 4.3 times greater improvement compared to placebo.

CureCell is pursuing systemic lupus erythematosus (SLE) treatment using CAR-T therapy ‘Anbalcell (CRC01)’. Phase 1/2 evaluates safety, tolerability, and efficacy in severe SLE patients unresponsive to existing treatments. This marks the first domestic CAR-T trial in autoimmune disease beyond hematologic cancers.

CAR-T therapies, initially focused on blood cancers, are increasingly recognized in the U.S. and Europe for severe autoimmune disease treatment. In March, Seoul St. Mary’s Hospital administered Anbalcell to severe SLE patients, confirming stable complete remission without side effects after stopping immunosuppressants. Anbalcell is currently under review for relapsed/refractory large B-cell lymphoma (LBCL) after completing Phase 2 trials.

Professor Joo Ji-hyun of Rheumatology at Seoul St. Mary’s Hospital, who conducted the compassionate use study in March, told Pharmaceutical News that CAR-T therapy is an appropriate targeted strategy for autoimmune diseases like lupus, which are B-cell centric, by removing pathological B cells using the same mechanism as in blood cancer treatment.

Celltrion is advancing ADC (antibody-drug conjugate) drug development. In July, Celltrion received domestic Phase 1 approval for ADC candidate ‘CT-P70’. CT-P70 had already received Phase 1 approval from the U.S. FDA in March. CT-P70 targets cMET, involved in cancer cell growth, and is being developed for solid tumors, including non-small cell lung cancer, colorectal cancer, and esophageal cancer. Preclinical studies showed strong tumor suppression and a high therapeutic index compared to competitors.

Celltrion also received approval for Phase 1/3 of the daratumumab biosimilar ‘CT-P44’, with Phase 3 trials actively ongoing in the U.S. and Europe.

Cyrus Therapeutics recently joined the development of the novel modality “targeted protein degradation”. The company received Phase 1 approval for the oral GSPT1-targeted protein degrader ‘CYRS1542’, which previously received IND approval from the FDA in April.

Preclinical data demonstrated excellent efficacy and a wide safety margin in difficult-to-treat solid tumors such as small cell lung cancer and metastatic castration-resistant prostate cancer. CYRS1542 was selected as a nonclinical stage support project under the 3rd National New Drug Development Program (KDDF) in 2023.

▼ 2025 July Biopharmaceutical Clinical Trial IND Approval Status

Source : https://www.yakup.com/news/index.html?mode=view&cat=12&nid=314470