Luokang New Medicine Is Running at a "New Speed" in Innovative Drug Development, with the Next 500-Million-Dollar Blockbuster Already in the Pipeline

How does AI · A2MS Platform help Cloud Top New Glory replicate success?

On March 9, Cloud Top New Glory announced that Vistip® (arginine etoposide tablets) issued China’s first prescription at the First Affiliated Hospital of Sun Yat-sen University, and on the same day, prescriptions were issued at eight tertiary hospitals in Guangzhou, Shanghai, Hangzhou, Xi’an, Chongqing, Beijing, and Nanjing, covering key regions nationwide from the first day of market launch. The company also expanded patient coverage through internet hospital channels.

Vistip® is an imported drug. Most imported drugs, after approval, require multiple steps such as customs clearance and logistics, usually taking three to four months to stabilize supply to the Chinese market. Vistip® was approved on February 2, and it took only 21 working days to reach pharmacies. Such rapid market entry is rare among innovative drugs introduced domestically. It once again demonstrates Cloud Top New Glory’s strong commercialization capabilities.

The most challenging part of bringing new drugs to market is gaining recognition from clinicians and obtaining prescriptions. Vistip® was recognized and prescribed by multiple top-tier hospitals in less than a month, which is closely related to its outstanding clinical value. Vistip® is an innovative oral medication for moderate to severe ulcerative colitis, capable of achieving deep mucosal healing, showing good efficacy and safety in long-term treatment. Clinical experts believe that this innovative oral therapy has advantages in both efficacy and convenience of use.

Professor Chen Minhu, former chair of the Gastroenterology Branch of the Chinese Medical Association, head of the Inflammatory Bowel Disease Group, and academic leader of Gastroenterology at Sun Yat-sen University First Affiliated Hospital, stated: “The issuance of the first prescription for Vistip® marks its official entry into clinical practice, bringing a more convenient and effective treatment option for patients suffering from long-term disease. Multiple global clinical studies confirm that Vistip® has significant efficacy, especially in rapid onset, steroid-free remission, and deep mucosal healing, with good safety.” In the field of ulcerative colitis treatment, oral regimens that combine deep mucosal healing with long-term safety are rare, which is the core reason why Vistip® quickly gained clinical attention.

In recent years, with changes in diet, lifestyle, and improved diagnostic levels, the number of inflammatory bowel disease (IBD) patients in China has continued to increase. IBD mainly includes ulcerative colitis and Crohn’s disease, with ulcerative colitis being one of the most common types. Data shows that the number of ulcerative colitis patients will grow from 980,000 in 2025 to about 1.5 million in 2031. However, for moderate to severe patients, there are still unmet treatment needs.

If Cloud Top New Glory can replicate the sales success of “Nuspar®,” it will once again validate its unique vision and sales ability in the large-demand ulcerative colitis market. Vistip® and Nuspar® together form a dual blockbuster of 5 billion yuan each, jointly supporting Cloud Top New Glory’s billion-yuan revenue target.

Hundreds of thousands of UC patients will see treatment upgrades, with Vistip® reshaping the treatment logic through “deep mucosal healing.”

Ulcerative colitis is a chronic inflammatory bowel disease with an unclear cause and prone to relapse. In recent years, the incidence and prevalence of ulcerative colitis in China have continued to rise. The disease manifests as mucus and bloody stools, abdominal pain, diarrhea, tenesmus, etc., severely affecting patients’ long-term quality of life.

Currently, treatment for moderate to severe ulcerative colitis mainly relies on steroids, immunosuppressants, and biologics. These options have limited efficacy or safety concerns over long-term use. For example, excessive steroid use can cause metabolic disorders and osteoporosis; immunosuppressants may trigger immune-related adverse reactions; JAK inhibitors are associated with risks of cardiovascular events and malignancies, leading the FDA to require black box warnings.

Vistip® is a new generation, highly selective S1P receptor modulator taken orally once daily, capable of achieving strong deep mucosal healing, thus improving long-term prognosis and reducing relapse and cancer risks. In the largest Asian multicenter Phase III clinical trial (ENLIGHT UC) for moderate to severe UC, Vistip® maintained treatment for 40 weeks, with a clinical remission rate of 48.1%, deep mucosal healing rate of 51.9%, and endoscopic normalization rate of 45.5%. In comparison, clinical remission rates for commonly used UC drugs like TNFα, IL-23, and JAK inhibitors are usually between 30%-40%.

Cloud Top New Glory CEO Luo Yongqing said: “Mucosal healing is the current treatment goal for ulcerative colitis, and early achievement can significantly reduce relapse, hospitalization, surgery, and cancer risks. Vistip® can control intestinal inflammation from the source, promote mucosal healing, and fill the gap in the treatment of moderate to severe ulcerative colitis.”

Moreover, in longer-term treatment, Vistip® shows even stronger advantages. Data from the global Phase III ELEVATE open-label extension study confirmed that after three years of continuous treatment, 86.8% of patients achieved clinical response, with clinical remission and mucosal healing rates maintained at around 60%. Five-year follow-up data from global clinical studies show that Vistip® has stable and good safety, with overall good tolerability.

Currently, the American Gastroenterological Association (AGA) clinical practice guidelines and the American College of Gastroenterology (ACG) guidelines both strongly recommend Vistip® as a first-line treatment for moderate to severe ulcerative colitis, reflecting high recognition from international authoritative academic institutions.

At the same time, Cloud Top New Glory has prepared for subsequent market deployment of Vistip®. In March last year, the company launched the local production project at the Jiashan factory, with an annual capacity expected to reach 5 million bottles after full operation.

From Nuspar® to Vistip®: Cloud Top New Glory’s commercialization capabilities are further validated

The rapid first prescription approval of Vistip® once again demonstrates Cloud Top New Glory’s excellent commercialization layout.

The “A2MS” commercial operation platform built by Cloud Top New Glory—integrating access, medical, market, and sales driven by scientific and commercial insights—is a complete system, with each link working in coordination at a level significantly above industry average. While promoting Vistip®’s approval and market access, the medical and marketing teams systematically disseminate academic knowledge, reaching clinicians and patients, and deepening clinical practice. In the “last mile” of drug logistics and sales, Cloud Top New Glory also performs better than industry peers.

Nuspar® used this approach, achieving over 1 billion RMB in sales in its first full year of commercialization, creating a record for non-oncology products and becoming the best-selling chronic disease drug in the medical insurance coverage. Behind this achievement is the abandonment of the industry’s common “massive sales tactics,” relying on a sales team of fewer than 200 people, with precise positioning of disease treatment concepts, solid real-world research, efficient access to medical insurance, and scientific hospital coverage layout. Cloud Top New Glory rapidly scaled up sales with maximum efficiency, fully validating its industry-leading A2MS integrated commercialization platform. If a single success is just the beginning, the company is further replicating success to unlock the full potential of the A2MS platform.

Now, Cloud Top New Glory’s focus is on continuously expanding Vistip®’s market and supply, improving commercialization efficiency. To develop the next billion-yuan blockbuster, access is just the first step.

Luo Yongqing expressed confidence in accelerating Vistip®’s commercialization, stating that the company will build multi-channel access systems, offer diversified patient assistance programs and innovative payment schemes, and strive to include Vistip® in the national medical insurance catalog to improve accessibility and affordability.

The successful commercialization of Nuspar® proves the feasibility of the A2MS model; Vistip® is the second product launched on this platform. Currently, half of the model validation is complete, and future sales results will be the best test of the A2MS approach.

Based on current epidemiological data for ulcerative colitis, clinical recognition of Vistip®, and Cloud Top New Glory’s early local production capacity deployment, it’s only a matter of time before Vistip® becomes the second Nuspar®.

Next, Cloud Top New Glory will continue to promote the realization of its “N+X” product portfolio, aiming to achieve its goal of reaching 15 billion RMB in revenue by 2030 and 30 billion RMB by 2035.

According to the company’s 2030 strategy, it will focus on a “dual-wheel drive” of “BD cooperation + self-research,” leveraging scientific and market insights to develop an N+X product portfolio in strategic fields, seizing opportunities for large-scale blue ocean products. Here, N refers to blockbuster products like Nuspar® and Vistip®, which can serve as growth engines; X refers to multiple synergistic products forming a collective advantage around the big hits.

Achieving this goal depends on efficient commercialization and multi-product synergy.

In conclusion:

In the future, Cloud Top New Glory will have more products like Nuspar® and Vistip®, with a clear strategic layout. As China’s biopharmaceutical R&D capabilities rapidly spill over and the country becomes a key global source of innovative pipelines, only a few companies possess the complete commercialization ability to efficiently and agilely execute all steps from access to supply.

Creating the first “billion-yuan product” is just the first step for Cloud Top New Glory. The industry’s shock from the A2MS platform lies in the fact that commercialization capability is now as important as R&D, becoming an indispensable core competency for innovative pharmaceutical companies.

As more innovative drugs enter commercialization, those who can efficiently and sustainably deliver quality medicines to patients will have a better chance of creating the next big blockbuster—Cloud Top New Glory is providing the answer through practice.

Written by: Miaomiao

Edited by: Jiang Yun, Jia Ting

Operations: 13th Twenty

Statement: Original content by Jian Shi Ju. Please do not reprint without permission.