[Edaily Reporter YU JIN-HEE ] Celltrion(068270)is expected to further accelerate its global new drug development efforts, buoyed by the U.S. health authorities’ sudden policy shift toward clinical development innovation. At a time when the company has pledged to transform itself from a biosimilar (generic biopharmaceutical) firm into a global new drug developer by significantly expanding its new drug pipeline, observers predict that the regulatory easing in the U.S.—the world’s largest pharmaceutical market—will directly benefit the company.

Synergy with Celltrion’s ‘Rapid Development Strategy’ Thanks to Superior Regulatory Communication Capabilities

According to the biotech industry on the 29th

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the U.S. Department of Health and Human Services (HHS) recently announced “Operation TrialBlazer,” an innovative policy designed to dramatically reduce delays in the early stages of clinical trials and strengthen U.S. clinical competitiveness, and published the related plan in the Federal Register.

The core of this policy is to streamline the vast amount of data and complex procedures previously required in the pre-Phase 1 stage, thereby shortening the time it takes to initiate clinical trials. U.S. health authorities plan to significantly simplify data submission processes that were redundant or unnecessary in existing Investigational New Drug (IND) applications, such as those related to drug manufacturing, quality control (CMC), and toxicity testing.

The U.S. Food and Drug Administration (FDA) estimates that once these regulatory improvements are fully implemented, the preparation period for Phase 1 clinical trials could be shortened by approximately 6 months to up to 1 year. As U.S. health authorities clearly recognize the issues of rising costs due to clinical trial delays and reduced patient access to treatments, comprehensive regulatory reforms are expected to follow, including streamlining the protocol amendment process, improving the efficiency of Institutional Review Board (IRB) reviews, and enhancing the process for recruiting clinical trial participants. Positive impacts are also anticipated for drug pipelines that have already entered the clinical trial phase.

The biotech industry analyzes this U.S. policy change not as a mere relaxation of safety standards, but as a measure to enhance the efficiency of early-phase clinical trials by increasing regulatory clarity. However, some interpret that the actual level of efficiency achievable in clinical settings will depend on the characteristics of the new drug candidate, each company’s development capabilities, and its ability to communicate with regulatory agencies.

Accordingly, the prevailing view is that Celltrion—which has extensive experience in formulating global clinical trial strategies and has maintained close communication with major regulatory agencies, including the FDA, over a long period—will secure a relatively distinct competitive advantage. This is because the company can maximize development efficiency, including time and cost savings, during the early stages when multiple new drug candidates are being developed simultaneously.

Celltrion has built a strong relationship of trust and extensive consultation experience with the FDA by successfully executing global clinical programs for numerous biosimilars and new drug candidates in its pipeline.

At the J.P. Morgan Healthcare Conference (JPM) held earlier this year, Celltrion unveiled a new drug pipeline encompassing next-generation modalities—including antibody-drug conjugates (ADCs), multi-antibodies, fetal Fc receptor (FcRn), and obesity treatments—and declared its ambition to become a global new drug development company. Celltrion’s rapid development strategy, aimed at enhancing efficiency in line with regulatory changes, is expected to create synergies with the U.S. government’s latest clinical innovation policies, thereby further accelerating the realization of its new drug development vision.

In particular, new drug candidates—including the ADC candidates CT-P70 and CT-P71, for which Celltrion has received Fast Track designation from the FDA, as well as CT-P73 and CT-P72 (ABP-102), which have currently entered Phase 1 clinical trials—are expected to benefit from these regulatory changes and gradually accelerate their development pace.

Shift in IND Package Strategy… 20 New Drug Candidates in the Pipeline by Next Year

Celltrion also views these U.S. clinical innovation policies as highly encouraging. The company’s strategy is to maximize development efficiency by responding agilely to policy changes in the U.S. market, leveraging its in-house global clinical trial design capabilities.

It is anticipated that once the new policy is fully implemented, the company’s clinical trial entry strategy will undergo significant revisions. Previously, the company’s approach was to unconditionally prioritize securing a comprehensive and voluminous set of data to obtain regulatory approval. However, going forward, it will be possible to transition to a strategy of rapidly entering clinical trials by submitting a streamlined IND package that is condensed to a level suitable for submission in phases.

Building on this enhanced development efficiency, Celltrion has set a clear goal of securing a total portfolio of 20 new drugs by next year. This figure—which includes the 16 drug candidates announced at JPM earlier this year plus additional candidates such as an oral obesity treatment—reflects the company’s strong commitment to new drug development. Celltrion plans to continue expanding its new drug pipeline and solidifying its position in the global market by actively combining efforts to strengthen its in-house research and development (R&D) capabilities with open innovation through the adoption of promising external technologies.

A Celltrion spokesperson stated, “This policy change in the U.S. is seen as a practical measure to reduce regulatory uncertainty and increase efficiency during the clinical trial process,” adding, “Celltrion will actively respond to the changing global regulatory environment to strengthen its competitiveness in new drug development and accelerate its transformation into a global pharmaceutical company.”