[Edaily Reporter KIM JI-WAN ] On the 6th, the pharmaceutical and life sciences sectors rose in tandem on the domestic stock market. The pharmaceutical sector rose 2.24% from the previous trading day. Of the 161 stocks in the sector, 97 rose, 45 fell, and 19 closed unchanged. The life sciences sector also rose 3.65% compared to the previous trading day. Of the 91 stocks in the sector, 51 rose, driving the sector’s upward trend.

Notable standout stocks included OncoTherapeutics, Qurient Co., Ltd., and Voronoi, Inc.

Onconic Therapeutics Inc. surged on news that “Zacubo,” its new drug for gastroesophageal reflux disease, had received its first overseas marketing approval in India.

Qurient Co., Ltd. continued its upward trend as securities firms released a series of reports offering positive assessments of the market competitiveness and technology transfer potential of its next-generation CDK7 inhibitor, “Mokasiclip.”

Voronoi, Inc. showed strength as its global clinical trials expanded smoothly, including the approval of a clinical trial in Hong Kong for “VRN11,” a treatment for non-small cell lung cancer.

Onconic Therapeutics Inc. Soars on ‘Zacubo’ Marketing Approval in India

#Onconic Therapeutics Inc.’s stock price surged after its new drug “Zacubo,” for gastroesophageal reflux disease, received marketing approval in India. According to KG Zeroin MP Doctor (formerly Marketpoint) on the same day, Onconic Therapeutics Inc. closed at 15,940 won, up 22.33% (2,910 won) from the previous day.

Onconic Therapeutics Inc. announced that zastafrazan, the active ingredient in Jacubo, received manufacturing and marketing approval from India’s Central Drugs Standard Control Organization (CDSCO) as a treatment for erosive gastroesophageal reflux disease.

With this approval, the company can now manufacture and distribute 20 mg zastafrazan citrate tablets in India. This marks the first time Jacubo has received formal marketing authorization from an overseas regulatory agency rather than a domestic one.

The approval process proceeded rapidly. Jacubo secured final approval in approximately two months after submitting its new drug application following the completion of its Phase 3 clinical trial in India last June. By completing the process from the end of the clinical trial to product approval in a short period, the company was able to significantly accelerate its entry into the local market.

Onconic Therapeutics Inc. signed an exclusive licensing agreement for Jacubo with an Indian pharmaceutical company in 2024. Under the agreement, the local partner will be responsible for clinical development, regulatory approval, production, and sales within India.

With marketing authorization now complete, both companies plan to proceed with follow-up tasks for the actual launch, including product registration, finalizing packaging design, establishing production and distribution networks, and conducting post-marketing surveillance (PMS).

With a population exceeding 1.4 billion, India is one of the world’s largest pharmaceutical consumer markets. Demand for GERD treatments is projected to grow steadily in line with economic growth and changes in lifestyle and dietary habits.

Until now, proton pump inhibitors (PPIs) have been the primary treatment for GERD. Recently, potassium-competitive acid blockers (P-CABs), which take effect quickly and provide long-lasting acid suppression, have been gaining attention as a new treatment alternative.

Jacqubo is a new P-CAB drug, and Onconic Therapeutics Inc. plans to expand its market share in India by replacing demand for existing PPI treatments.

This approval also diversifies the company’s revenue streams. In addition to milestone payments tied to achieving regulatory milestones, the company can expect royalty revenue linked to product sales once local sales begin. This marks a transition for Jacubo’s overseas business from a focus on R&D and technology transfer to a phase of generating actual sales revenue.

In the domestic market as well, Jacubo is rapidly increasing its prescription volume. Since its launch in October 2024, it recorded prescription sales of 21.2 billion won in the first quarter of this year and 25.6 billion won in the second quarter.

Onconic Therapeutics Inc. has currently launched Jacubo in 27 countries, including China, India, and Central and South America, and is proceeding with clinical trials, marketing authorization, and launch procedures on a country-by-country basis.

An Onconic Therapeutics Inc. official stated, “Following the successful completion of the Phase 3 clinical trial in India last June and the submission of a new drug application, we obtained the manufacturing and marketing authorization in just about two months, making the launch of Jacubo in India even more tangible.” The official added, “We will proceed smoothly with launch preparations alongside our local partner to ensure Jacubo’s stable entry into the Indian market, which will lead to expanded global sales and the generation of royalty revenue.”

Qurient Co., Ltd.

Continues

Uptrend

Amid

Positive Brokerage Reports… Expectations for New CDK7 Drug Grow

Qurient Co., Ltd.(115180)continued its strong performance for consecutive days on the back of

positive brokerage reports

. Expectations regarding technology transfers and clinical results drove the stock price higher, as the next-generation CDK7 inhibitor “Mokasiclip (Q901)” is viewed as a potential game-changer targeting the $15 billion breast cancer treatment market.

On that day, Qurient Co., Ltd. closed at 23,400 won, up 1,800 won (8.33%) from the previous trading day. This continued the upward trend that followed a 27.25% surge on the 4th.

The catalyst for the stock’s rise was a report by Shinhan Investment Securities identifying Qurient Co., Ltd. as a key beneficiary in the next-generation CDK7 inhibitor market. Subsequent analyses highlighting Mokasyclip’s differentiated mechanism of action and potential for technology transfer are believed to have further improved investor sentiment.

Shinhan Investment Securities highlighted that the global breast cancer treatment market is shifting its focus from HER2-positive patients to HR+/HER2- patients. The CDK4/6 inhibitor market—represented by Pfizer’s “Ibrance,” Novartis’ “Kisqali,” and Eli Lilly’s “Verzenio”—grew to approximately $14.6 billion (20.7991 trillion won) last year. It is projected to expand to $17.5 billion (24.9305 trillion won) by 2030.

This is more than twice the size of the market for HER2-targeted antibody-drug conjugates (ADCs), such as “Enhertu.” However, currently commercialized CDK4/6 inhibitors have the limitation that resistance can develop during long-term administration. Consequently, global pharmaceutical companies such as Roche, Novartis, and Gilead are engaging in large-scale acquisitions and technology transfers to secure next-generation CDK-class therapies.

The securities industry assesses that Qurient Co., Ltd.’s Mokasiclip could directly benefit from this market realignment. Mokasiclip is an anticancer candidate that selectively inhibits CDK7, which is involved in cancer cell proliferation and DNA damage repair.

In particular, analyses suggest that it possesses competitive advantages compared to “REC-617” from Recession Pharma, a global competitor. Its ability to simultaneously overcome resistance not only to CDK4/6 inhibitors but also to that arising after treatment with topoisomerase 1 (Topo-1)-based ADCs is cited as a key differentiator.

A combination strategy with ADCs loaded with Topo-1-targeted drugs is also drawing attention. If Mokasyclip demonstrates that it enhances the efficacy of ADC treatment or delays the onset of resistance, the potential for joint development and technology transfer with global ADC developers could increase.

Qurient Co., Ltd. plans to release Phase 2 clinical trial data for Mokasclip in the second half of this year. The technology transfer negotiations currently underway are also considered a key factor influencing the stock price. The securities industry forecasts that if efficacy and safety are confirmed in the clinical data and a technology transfer agreement is finalized, the commercial value of Mokasclip could be significantly reevaluated.

A securities industry official stated, “With the CDK4/6 inhibitor market already approaching $15 billion, global pharmaceutical companies are showing increasing interest in next-generation candidates capable of overcoming treatment resistance,” adding, “Future clinical data and technology transfer outcomes will be key factors in determining Qurient Co., Ltd.’s enterprise value.”

Voronoi, Inc. Rises on Smooth Progress of VRN11 Global Clinical Trials

Voronoi, Inc.(310210)continued its upward trend amid expectations for the global expansion of clinical trials for its next-generation non-small cell lung cancer treatment, “VRN11.” Investor sentiment was boosted by assessments that the development schedule is proceeding without a hitch, following the approval of the clinical trial plan in Hong Kong after it was previously approved in Australia.

On that day, Voronoi, Inc. closed at 157,500 won, up 10,000 won (6.78%) from the previous trading day.

The stock’s strength is believed to be driven by news that the number of countries involved in VRN11’s clinical development continues to grow. Voronoi, Inc. announced on the 3rd that it had received approval from the Hong Kong Department of Health for its Phase 1b/2 clinical trial plan for VRN11.

VRN11 is a next-generation non-small cell lung cancer (NSCLC) treatment candidate that targets epidermal growth factor receptor (EGFR) mutations. Professor Molly Lee of the Prince of Wales Hospital, an expert in EGFR-mutated NSCLC, will serve as the principal investigator for this Hong Kong clinical trial.

Following its trial in Australia, Voronoi, Inc. plans to conduct a clinical trial in Hong Kong targeting patients who have not yet received prior treatment. This strategy aims to expand the scope of development to include not only patients whose disease has progressed after prior treatment but also those receiving initial treatment.

The company explained that it had confirmed VRN11’s anticancer efficacy and tolerability in previous clinical trials. In particular, several cases of intracranial complete remission were observed among patients who developed brain metastases after receiving third-generation EGFR-targeted therapy.

The median intracranial progression-free survival has not yet been reached as of the current analysis. Since approximately 80% of the clinical trial participants are continuing treatment, there is hope that long-term suppression of brain metastases—lasting more than nine months—may be achieved.

The geographic scope of VRN11’s clinical trials is also steadily expanding. Voronoi, Inc. is currently undergoing the approval process for clinical trial protocols in countries including South Korea, Canada, Singapore, Malaysia, Spain, and France.

As the number of countries participating in clinical trials increases, patient recruitment is expected to accelerate, and the scope of clinical data collection is likely to expand. The securities industry anticipates that, if global clinical trials proceed as planned, expectations for the technology transfer and commercialization of VRN11 will also rise.

Voronoi, Inc. stated, “We are smoothly expanding our Phase 1b/2 clinical trials in major global markets,” adding, “In addition to the countries where INDs have already been approved, we are currently undergoing the national clinical trial protocol approval process in South Korea, Canada, Singapore, Malaysia, Spain, and France.”