Novotech Earns Frost & Sullivan's 2025 Global Company of the Year Recognition for Excellence in Biotech Clinical Research Services

Recognized for its biotech-first focus, innovation in clinical trial delivery, and best-in-class client experience, Novotech sets the global standard in contract research for biotechs and small- mid-size pharma companies.

SAN ANTONIO, July 3, 2025 /PRNewswire/ -- Frost & Sullivan is pleased to announce that Novotech has been awarded the 2025 Global Company of the Year Award in the biotech contract research organization (CRO) industry for its outstanding achievements in clinical trial innovation, strategic execution, and client-centric delivery. This recognition highlights Novotech's leadership in enabling biotech and small to mid-sized pharma companies to accelerate therapeutic development globally through flexible, high-touch, and technologically advanced clinical trial services.

The company stands apart in the global CRO landscape with its strategic emphasis on serving biotech clients, offering tailored clinical trial solutions across all phases of development. The company operates in more than 30 locations and has cultivated deep local insights across key clinical trial hubs, including Australia, South Korea, India, China, and the United States. Its ability to combine global standards with regional excellence makes Novotech a trusted partner for biotech sponsors worldwide.

"Novotech is redefining biotech-focused clinical research through AI-driven innovation, global expansion, and a client-embedded partnership model. With a clear vision to be the CRO of choice for biotech and small to midsize pharma, Novotech leverages deep therapeutic expertise and regional agility to deliver speed, flexibility, and transformative impact in clinical trials," said Unmesh Lal, vice president, healthcare & life sciences at Frost & Sullivan.

With nearly three decades of experience, Novotech has built a robust reputation for delivering high-quality clinical trials at speed. Its integrated service model encompasses regulatory consulting, clinical operations, biometrics, data management, and medical writing, allowing clients to streamline their development pipelines from early phase to post-marketing studies. Through a powerful combination of local knowledge, scientific expertise, and digital capabilities, Novotech continues to enhance trial efficiency, patient recruitment, and regulatory outcomes.

Novotech's dedication to advancing clinical research is further reflected in its strategic acquisitions and partnerships. The company's expansions into the United States and Europe marked a significant milestone in building a globally unified platform while preserving its excellence in APAC operations. Novotech's sustained growth trajectory is driven by its deep alignment with sponsors' evolving needs and its commitment to scientific excellence and operational agility.

"We're honored by Frost & Sullivan's recognition, which highlights Novotech's strategic focus on delivering regional expertise through a global model to support biotech and mid-size pharma sponsors. It also reflects the strength of our teams in driving operational, scientific, and client delivery excellence worldwide," said Dr. John Moller, chief executive officer, Novotech

Novotech's unwavering commitment to client experience strengthens its position in the market. By streamlining service delivery, enabling real-time trial visibility through advanced digital systems, and maintaining continuity across project teams, the company delivers exceptional client satisfaction. Its regionalized, partner-led delivery model and localized expertise ensure regulatory compliance and cultural alignment—key factors that drive trial success in various markets.

Frost & Sullivan commends Novotech for setting a high standard in competitive strategy, execution, and market responsiveness. The company's vision, innovation pipeline, and client-first culture are shaping the future of biotech clinical trials and driving tangible outcomes that matter to patients and sponsors.

Each year, Frost & Sullivan presents the Company of the Year Award to a company that demonstrates outstanding strategy development and implementation, resulting in measurable improvements in market share, client satisfaction, and competitive positioning. The award recognizes forward-thinking organizations that are reshaping their industries through innovation and growth excellence.

Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, client service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.

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Contact:
Tarini Singh
E: Tarini.Singh@frost.com

About Novotech
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company trusted by biotech and small- to mid-sized pharmaceutical companies to guide drug development at every phase.
With a global footprint that includes 30+ offices across the Asia-Pacific region, North America, and Europe and partnerships with 5,000+ trial sites, Novotech provides clients an accelerated path to bring life-changing therapies to market by providing access to key clinical trial destinations and diverse patient populations. 

Through its client-centric service model, Novotech seamlessly integrates people, processes, and technologies to deliver customized solutions that accelerate the path to market for life-changing therapies. By adopting a true partnership approach, Novotech shares a steadfast commitment to client success, empowering innovation, and advancing healthcare worldwide. Recipient of numerous industry accolades, including the Frost & Sullivan CRO Company of the Year award for 19 consecutive years, Novotech is recognized for its excellence in clinical trial execution and innovation. Its deep therapeutic and regulatory expertise, combined with local market insights, ensures streamlined clinical trials, optimized data analytics, and accelerated patient recruitment strategies. 

Together with clients, Novotech transforms scientific advancements into therapies that improve global health outcomes, embodying a mission of driving innovation and delivering impactful results.

For more information visit www.Novotech-CRO.com

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Novotech Earns Frost & Sullivan's 2025 Global Company of the Year Recognition for Excellence in Biotech Clinical Research Services

CHENGDU, China, May 30, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) announced that at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA, results from the pivotal Phase II study of the Company's next-generation selective RET inhibitor, lunbotinib fumarate (A400/EP0031, 宁泰莱^®[1]), in advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) were presented as an oral report by Professor Qing Zhou from Guangdong Provincial People's Hospital (Abstract #8505, Lung Cancer—Metastatic Non-Small Cell). Based on these results, a New Drug Application (NDA) for lunbotinib fumarate for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC has been accepted by the National Medical Products Administration (NMPA) of China.

The study enrolled 71 patients who had previously received platinum-based chemotherapy and immunotherapy (pre-treated patients) and 92 patients who had not received prior systemic therapy (treatment-naïve patients). As of the data cutoff date of October 29, 2025, the median follow-up was 22.6 months and 20.7 months, respectively.

The confirmed objective response rate (ORR) assessed by Independent Review Committee (IRC) was 81.3% (95% CI: 71.8–88.7) in treatment-naïve patients and 87.1% (95% CI: 77.0–93.9) in pre-treated patients.

In treatment-naïve patients, median duration of response (mDOR) and median progression-free survival (mPFS) were not reached. In pre-treated patients, mDOR was 25.7 months, and mPFS was 27.5 months.

Among 40 patients with central nervous system (CNS) metastases at baseline (assessed by IRC per response assessment in neuro-oncology brain metastases (RANO-BM) criteria), the intracranial complete response (CR) rate was 30%, and the disease control rate (DCR) was 92.5% (95% CI: 79.6–98.4).

Lunbotinib fumarate was well tolerated, with treatment-related adverse events (TRAEs) being predominantly Grade 1–2. The rate of permanent discontinuation due to TRAEs was 1.2%, and no treatment-related deaths were reported.

The study shows that lunbotinib fumarate demonstrated robust and durable clinical activity in RET fusion-positive NSCLC, regardless of line of therapy, in a largely poor-prognostic patient population. Favorable CNS efficacy was observed in patients with measurable baseline CNS metastases. The safety profile was manageable, with no unexpected safety signals.

Professor Qing Zhou, principal investigator from Guangdong Provincial People's Hospital, said: "From the first presentation of Phase I data at ASCO 2023 to today's pivotal Phase II results, we have witnessed the progression of lunbotinib fumarate from early exploration to a confirmatory study. These data show that lunbotinib fumarate delivers robust and durable responses in both treatment-naïve and pre-treated patients with RET fusion-positive NSCLC, with particularly remarkable intracranial efficacy in patients with CNS metastases at baseline. As a next-generation selective RET inhibitor, it will offer an important new treatment option for patients."