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出海弄潮儿|君实生物:瞄准未满足的临床需求,差异化产品“出海”打开国际化布局

Global Pioneer | Junshi Biosciences: Targeting Unmet Clinical Needs with Differentiated Products to Expand International Presence

“经过近十年的发展,中国生物医药企业,特别是创新药企业,已成功跻身追赶全球领先跨国药企的行列,这是值得整个中国医药行业值得为之自豪的事情。”

"After nearly a decade of development, Chinese biopharmaceutical companies, especially innovative drug firms, have successfully caught up with leading global multinational pharmaceutical corporations—an achievement worthy of pride for China's entire medical industry."

在君实生物相关负责人看来,“走出去”是一种资源上的整合再利用,是药企理所应当的选择。

According to Junshi Biosciences' executives, "going global" represents a strategic integration of resources and is a natural choice for pharmaceutical companies.

2023年10月,君实生物迎来了国际化进程中的重要里程碑——特瑞普利单抗(商品名:拓益)在美国获批上市。由于美国此前尚未批准肿瘤免疫疗法用于鼻咽癌治疗,特瑞普利单抗申请的鼻咽癌适应症符合“未被满足的临床需求”。

In October 2023, Junshi Biosciences achieved a major milestone in its globalization journey—the approval of toripalimab (brand name: Tuoyi) in the U.S. market. As no immunotherapy had been approved for nasopharyngeal carcinoma (NPC) treatment in the U.S. before, toripalimab's NPC indication addressed an "unmet clinical need."

从特瑞普利单抗交出的“成绩单”来看,其2023年销售收入达9.19亿元,同比增长25%,在君实生物总营收中占比超60%。目前,君实生物正在积极推进特瑞普利单抗在全球更多地区上市。

Toripalimab delivered strong performance in 2023, generating ¥919 million in sales revenue—a 25% year-on-year increase—accounting for over 60% of Junshi Biosciences' total revenue. The company is now accelerating toripalimab's global expansion.

国产创新药的成功“出海”并非一路坦途。君实生物相关负责人坦言:“由于法规、文化和市场熟悉度等限制因素,无论是大型企业还是小型企业,在走出去时都可能出现‘水土不服’的现象。只有清晰定位产品价值,掌握国际市场规则,才能做到产品全生命周期价值最大化。”

The global expansion of China's innovative drugs hasn't been smooth sailing. Junshi Biosciences' executives noted: "Due to regulatory, cultural, and market familiarity barriers, companies of all sizes may face challenges when going global. Only by clearly defining product value and mastering international market rules can we maximize a product's lifecycle value."

手握首款叩开FDA大门的国产PD-1,君实生物深知产品“出海”是一个战略性决策。早在产品立项阶段,君实生物就充分考虑国际监管要求,制定从研发到临床的策略,构建对标国际标准的质量体系,在质量和生产团队中树立国际理念,不断补齐硬件短板。

As the first Chinese-developed PD-1 inhibitor approved by the FDA, Junshi Biosciences recognizes that global expansion is a strategic decision. From early development stages, the company has incorporated international regulatory requirements, established global-standard quality systems, and cultivated an international mindset across teams while upgrading hardware capabilities.

国际化策略:差异化合作模式

Globalization Strategy: Differentiated Partnership Models

在国际化进程中,君实生物也不止步“一揽子”交付产品给单一合作伙伴。而是对不同地区采用差异化布局策略,精准选择合作伙伴,定位最准确的“出海”模式。

In its globalization journey, Junshi Biosciences avoids a "one-size-fits-all" partnership approach. Instead, it adopts region-specific strategies, carefully selecting partners to optimize market entry models.

对于“出海”模式的选择,君实生物相信,license out与自建临床/商业化团队的自主出海没有孰优孰劣,主要取决于企业自身的定位和发展阶段。Licence-out能够在保障公司利益的前提下,降低公司及产品国际化的成本与风险,提升公司整体经营能力以及行业影响力。

Regarding globalization models, Junshi Biosciences believes neither license-out nor establishing independent clinical/commercial teams is inherently superior—the choice depends on a company's positioning and development stage. License-out can reduce internationalization costs/risks while enhancing operational capabilities and industry influence.

同时,君实生物也在积极探索自主商业化道路。公司相关负责人表示,当企业进入临床和商业化阶段的“出海”产品不断增加,同步扩充海外研发和商业化团队,企业将更加具备自主出海的条件。

Meanwhile, Junshi Biosciences is exploring independent commercialization. Executives stated that as more products enter global clinical/commercial phases and overseas teams expand, companies gain stronger capabilities for independent international expansion.

创新药企的全球化视野

The Global Vision of Innovative Pharma Companies

“优秀的创新药企具备全球视野、注重创新,以国际化为主要生存空间。特别是以全球first-in-classbest-in-class药物为突破点,开发出真正的创新产品,在国内乃至国际市场都极具竞争力”,君实生物相关负责人谈到,“出海”不仅是创新药企竞争优势的体现,也是产业发展的必然要求。

"Leading innovative pharma companies think globally, prioritize innovation, and view internationalization as key to survival. Developing true first-in-class or best-in-class drugs creates competitive advantages domestically and globally," Junshi Biosciences executives noted, adding that global expansion reflects competitive strengths and industry evolution.

“由于创新药企形成全产业链运营的时间不长,商业化方面可能受到来自传统药企的压力,所以更需要在国际化道路上走得更快、更迫切一些。”

"As innovative pharma companies are relatively new to full industrial chain operations and face commercialization pressures from traditional firms, accelerating international expansion becomes even more urgent."