Onconic Surges on Jaqbo’s India Approval[K-Bio Pulse]

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[Jiwan Kim, Edaily Reporter] South Korea's pharmaceutical and life sciences sectors advanced in tandem on Aug. 6, led by Onconic Therapeutics, Qurient and Voronoi.

The pharmaceutical index gained 2.24%, with 97 of 161 stocks closing higher, 45 declining and 19 unchanged. The life sciences index rose 3.65%, supported by gains in 51 of its 91 constituents.

Jaqbo tablets, a treatment for gastroesophageal reflux disease (GERD).

Onconic Therapeutics surged after its gastroesophageal reflux disease drug Jaqbo secured its first overseas marketing approval in India. Qurient extended its rally on brokerage reports highlighting the potential of its CDK7 inhibitor mocaciclib, while Voronoi gained as its next-generation lung cancer candidate VRN11 continued to expand its global clinical programme.

Onconic Therapeutics Jumps on Indian Approval for Jaqbo

Onconic Therapeutics closed at KRW15,940, up 22.33%, after announcing that India's Central Drugs Standard Control Organisation had approved zastaprazan, the active ingredient in Jaqbo, for the treatment of erosive gastroesophageal reflux disease.

The approval allows 20mg zastaprazan citrate tablets to be manufactured and sold in India. It marks the first overseas regulatory approval for Jaqbo.

The review process moved quickly. Onconic completed a Phase 3 trial in India and submitted its new drug application in June, receiving final approval approximately two months later.

The company signed an exclusive licensing agreement with an Indian pharmaceutical partner in 2024. The local partner is responsible for development, regulatory affairs, manufacturing and commercialisation in India. Following approval, the companies will proceed with product registration, packaging, production, distribution and post-marketing surveillance.

Jaqbo is a potassium-competitive acid blocker, or P-CAB, designed to provide rapid and sustained acid suppression. P-CAB therapies are emerging as alternatives to proton pump inhibitors, which have traditionally dominated the gastroesophageal reflux disease market.

The approval could generate both regulatory milestone payments and royalties once commercial sales begin. It also represents a shift in Jaqbo's overseas business from licensing and development toward revenue-generating commercialisation.

Jaqbo was launched in South Korea in October 2024 and recorded prescription sales of KRW21.2 billion in the first quarter and KRW25.6 billion in the second quarter. The drug has entered 27 countries, including China, India and several Latin American markets.

"Following the successful Indian Phase 3 trial and new drug application in June, the manufacturing and marketing approval secured in about two months has brought Jaqbo's Indian launch significantly closer," an Onconic Therapeutics official said. "We will work closely with our local partner to establish Jaqbo successfully in India and translate the launch into global sales growth and royalty revenue."

Qurient Extends Rally on CDK7 Drug Outlook

Qurient rose 8.33% to KRW23,400, extending gains after jumping 27.25% on Aug. 4.

The rally was driven by brokerage reports identifying the company as a potential beneficiary of growing interest in next-generation CDK inhibitors. Shinhan Securities highlighted mocaciclib, also known as Q901, as a prospective treatment for patients who develop resistance to existing breast cancer therapies.

The global CDK4/6 inhibitor market, led by Pfizer's Ibrance, Novartis' Kisqali and Eli Lilly's Verzenio, reached approximately $14.6 billion last year and is projected to expand to $17.5 billion by 2030.



However, resistance frequently develops during prolonged CDK4/6 inhibitor treatment, prompting global pharmaceutical companies to invest in next-generation CDK assets.

Mocaciclib selectively inhibits CDK7, a protein involved in cancer-cell proliferation and DNA-damage repair. Analysts said the drug could potentially address resistance to both CDK4/6 inhibitors and antibody-drug conjugates carrying topoisomerase-1 payloads.

Its potential use in combination with Topo-1-based antibody-drug conjugates may also create partnership opportunities with global ADC developers.

Qurient is expected to release Phase 2 clinical data for mocaciclib in the second half of this year. Progress in licensing discussions and clinical results will be key factors in determining whether the drug's value receives a further re-rating.

Voronoi Gains as VRN11 Clinical Programme Expands

Voronoi advanced 6.78% to KRW157,500 as investors welcomed the continued global expansion of the clinical programme for VRN11, its next-generation EGFR-targeted treatment for non-small cell lung cancer.

The company recently received approval from Hong Kong's Department of Health to conduct a Phase 1b/2 trial. The study will be led by Professor Molly Li of Prince of Wales Hospital, an expert in EGFR-mutated non-small cell lung cancer.

Following Australia, Hong Kong will enrol treatment-naive patients, expanding development beyond patients whose disease progressed after previous therapies.



Voronoi said earlier clinical studies demonstrated promising efficacy and tolerability. Several intracranial complete responses were observed among patients who developed brain metastases after third-generation EGFR-targeted therapy.

Median intracranial progression-free survival had not been reached at the latest analysis, while approximately 80% of patients remained on treatment. The findings suggest the possibility of sustained intracranial disease control lasting more than nine months.

The company is also pursuing clinical trial approvals in South Korea, Canada, Singapore, Malaysia, Spain and France.

"We are smoothly expanding the Phase 1b/2 programme across major global markets," a Voronoi official said. "In addition to countries where the IND has already been approved, regulatory reviews are under way in South Korea, Canada, Singapore, Malaysia, Spain and France."