A Resilient Cure for Japan's 'Drug Loss' Problem

TOKYO & BLAINVILLE, QC – December 15, 2025 – In a move that signals both strategic foresight and a commitment to public health, Canadian specialty firm Duchesnay Inc. and Japanese pharmaceutical stalwart Mochida Pharmaceutical Co., Ltd. have announced a landmark licensing agreement. The partnership aims to introduce Bonjesta®, a widely used treatment for nausea and vomiting of pregnancy (NVP), to Japan. While on the surface a standard cross-border deal, this collaboration represents a potent response to one of the Japanese healthcare system's most persistent challenges: the 'drug loss' phenomenon that leaves its population without access to medicines readily available in the West.

For investors focused on long-term, stable returns, this partnership is more than just a market entry; it's a case study in resilience. It demonstrates how two companies can navigate significant regulatory and economic headwinds by identifying a critical, unmet need and leveraging complementary strengths to create sustainable value.

The Crisis of Access: NVP and Japan's Drug Gap

To understand the significance of this deal, one must first grasp the dual crises it addresses. The first is medical. Nausea and vomiting of pregnancy is a debilitating condition affecting more than half of all pregnant women in Japan. Despite its prevalence and impact on quality of life, there are currently no approved pharmacological treatments for NVP in the country. Expectant mothers and their doctors are left to manage symptoms with non-pharmacological methods like dietary changes or the off-label use of other medications, often with limited evidence of efficacy.

The second crisis is systemic. Japan suffers from a well-documented 'drug loss,' a situation where innovative therapies approved in the U.S. and Europe fail to reach the Japanese market. Recent estimates suggest that nearly 70% of new drugs commercialized in the West are not available in Japan. This gap is driven by a confluence of factors: a historically complex and lengthy regulatory process at the Pharmaceuticals and Medical Devices Agency (PMDA), pricing policies that can disincentivize foreign investment, and stringent requirements for local clinical trials, or 'bridging studies,' to validate a drug's efficacy specifically within the Japanese population.

Japan's Ministry of Health, Labour and Welfare (MHLW) has not been idle, actively encouraging companies to tackle this issue, particularly for drugs with high medical necessity. The call from the Japan Society of Obstetrics and Gynecology to develop an NVP treatment was a direct catalyst for this initiative. The Duchesnay-Mochida partnership is a direct and powerful answer to that call.

A Blueprint for Strategic International Partnership

This agreement provides a compelling blueprint for navigating complex international markets, a hallmark of resilient companies. For Duchesnay, a Quebec-based company focused on women's health, this move marks a pivotal moment in its global expansion.

Rather than attempting a solo entry into Japan's challenging market, Duchesnay has partnered with a local champion. Mochida, a company with over a century of history and a deeply entrenched presence in Japanese obstetrics and gynecology, is the ideal partner to steer Bonjesta® through the intricate PMDA approval process. Mochida will conduct the necessary local research and clinical activities required to secure regulatory approval, a process that can take years and requires immense local expertise.

As Suzanne Paszkiewicz, Vice President at Duchesnay Pharmaceutical Group, stated, "This agreement marks a significant milestone for Duchesnay, contributing to our continued international expansion." The partnership allows Duchesnay to access one of the world's largest pharmaceutical markets while mitigating the immense risk and cost of navigating its regulatory and commercial landscape alone.

For Mochida, the benefits are equally clear. The agreement allows the company to add a proven, high-demand product to its robust women's health portfolio with minimal R&D risk. Bonjesta®, an oral combination of doxylamine succinate and pyridoxine hydrochloride, is already approved in 43 countries, including by the FDA in the U.S. (2016) and in Europe (2023). By licensing a globally recognized therapy, Mochida reinforces its market leadership, aligns with national health priorities, and strengthens its pipeline for long-term growth.

"By helping to reduce the burden of NVP symptoms for pregnant women and creating an environment in which women can work and live with less stress during their pregnancy, we aim to contribute to the realization of a society in which women enjoy better health and can actively participate," said Junichi Sakaki, a Representative Director at Mochida. This statement underscores the synergy between commercial opportunity and societal benefit that defines a truly resilient enterprise.

The Long Road to Market: Patience and Process

The anticipated launch of Bonjesta® in Japan by 2030 highlights a key theme for investors: this is not a short-term play. The path to approval is a multi-year marathon, not a sprint. Mochida will need to navigate the PMDA's rigorous review, which includes scientific evaluation, facility inspections, and potentially new bridging studies to confirm the drug's safety and efficacy in Japanese patients.

Furthermore, even after approval, new drugs in Japan are subject to a unique post-marketing re-examination period lasting up to ten years, a stringent pharmacovigilance requirement that ensures long-term safety monitoring. This methodical, data-driven approach, while lengthy, ultimately builds deep market trust and solidifies a product's position for the long run.

This extended timeline is not a deterrent but rather a feature of a stable investment strategy. The partnership is built on a realistic understanding of the regulatory environment, and the projected 2030 launch reflects a calculated, long-term commitment. It is this kind of patient, process-driven approach that allows companies to build lasting franchises in durable markets.

By taking on this challenge, Mochida and Duchesnay are not just seeking profit; they are building a foundation of trust with regulators, healthcare providers, and patients. This foundation is invaluable in a market that prioritizes safety and long-term evidence. The collaboration demonstrates a shared vision that looks beyond quarterly earnings to focus on establishing a new standard of care that will deliver value for years, if not decades, to come.

For investors focused on long-term stability, this partnership serves as a compelling case study in how targeted, strategic collaboration can unlock value and build resilience in even the most challenging of global markets.