Dectrombopag new indication "First in the world" lands in China: Accelerated approval process and bidirectional efforts of multinational pharmaceutical companies

At the critical point when the biopharmaceutical industry is moving toward high-quality development, a drug’s “global first batch” approval is no longer merely a symbol of review efficiency. It has become a microcosm of the coordinated evolution of the entire industry ecosystem, changes in regulatory capability, and companies’ R&D strategy and deployment.

Recently, AstraZeneca announced that its HER2-targeted antibody-drug conjugate (ADC) drug, trastuzumab deruxtecan, has received approval in China for a milestone new indication: sequential THP therapy as a new adjuvant treatment for HER2-positive early breast cancer. This approval is based on the positive results from DESTINY-Breast11 (DB11) global Phase III trial.

This event not only marks the successful “frontward shift” of the drug’s use from late-line treatment to early-stage treatment. At the same time, this new indication was the first in China to be approved, making it a “global first batch.”

Dr. Jing He, Global Senior Vice President of AstraZeneca and Head of Global R&D China, candidly stated that the first approval of DB11 in China was not accidental, but the result of “timing, location, and people” working together. Behind this event are structural leaps driven by institutional optimization in China’s drug review reform, the redefinition of China’s strategic position by multinational pharmaceutical companies, and the continuous rise of AstraZeneca China’s R&D team’s voice in the company’s global R&D network.

Dr. Jing He, Global Senior Vice President of AstraZeneca and Head of Global R&D China

Achieving a “global first batch” in China for this indication is only a small part of AstraZeneca’s broader in-China plan—ranging from the rapid introduction of next-generation modalities to the localization of end-to-end capabilities along the entire value chain. This multinational pharmaceutical company is building an unprecedented innovation closed loop in China.

“All subtypes, all life stages” pipeline strategy: priority considerations for clinical needs in breast cancer

The approval of a new indication for trastuzumab deruxtecan advances its treatment stage in breast cancer from late-stage therapy to early-stage neoadjuvant treatment. This is an important step in AstraZeneca’s “all subtypes, all life stages” strategy in breast cancer, and it further validates the clinical value of its next-generation treatment model.

As a representative HER2 ADC, trastuzumab deruxtecan—starting from DB03 (late-line, second-line)—to DB09 (late-line, first-line), whose application has now been submitted, and then to DB11 (early-stage, neoadjuvant setting). AstraZeneca’s series of studies has not been developed one by one; instead, years ago it began to build coverage for breast cancer across the entire disease course in parallel.

Jing He said that this “rollout across the entire line” strategy is based on a core judgment: the earlier treatment begins, the greater the hope that patients may be cured. We hope that patients at different stages—whether they are newly diagnosed and treatment-naïve or they have recurrence and metastasis—will all have the opportunity to benefit.

Approximately one fifth of breast cancer cases are considered HER2-positive. For patients with HER2-positive early breast cancer, after conventional neoadjuvant therapy, about half do not achieve pathologic complete response (pCR), facing a higher risk of recurrence. The approval of this new indication gives these patients a new treatment option and hope for “clinical cure.”

Breast cancer is not a single disease. It is a disease spectrum that includes different molecular subtypes such as HR-positive, HER2-positive, and triple-negative breast cancer (TNBC). Only by delivering precise diagnosis and treatment based on the biological characteristics of different subtypes can the long-term vision of “making cancer no longer the cause of death” be achieved. AstraZeneca’s strategy in breast cancer is precisely based on an in-depth understanding of the biological characteristics of different subtypes, and leverages its advantages in technology platforms. In addition to HER2-positive breast cancer, AstraZeneca is equally well equipped in two other major subtypes—HR-positive and triple-negative breast cancer—building a rich systemic matrix from “endocrine therapy” to “precise targeted therapy.”

Jing He pointed out that in setting R&D priorities, AstraZeneca does not simply weigh between “curing in early-stage” and “extending survival in late-stage.” Instead, it makes a comprehensive judgment across three dimensions: strategic value, commercial value, and scientific value. Among these, the core of scientific value lies in whether it truly addresses unmet clinical needs.

“Now many people talk about ‘unmet clinical needs.’ Sometimes it sounds like a stock phrase, but in reality it’s not.” Jing He emphasized, “The truly ‘unmet clinical needs’ hinges on whether we are only solving problems that are irrelevant to patients, or whether we are actually improving their quality of life and extending their life span.”

Based on this judgment, AstraZeneca has established several core strategies in its global oncology development: making full use of its rich product pipeline to explore combination therapies of different modalities such as immunotherapy and ADCs; and at the same time pushing treatment stages forward. This includes not only breast cancer, but also rapid advancement in areas such as lung cancer, genitourinary system tumors, and gastric cancer, as well as more precise patient selection.

Jing He observed that the National Medical Products Administration’s Center for Drug Evaluation (CDE) is also increasingly considering unmet clinical needs in its review process, while adhering to a science- and data-driven approach. This aligns with AstraZeneca’s R&D value philosophy.

From “sync” to “first batch”: an inevitable result of strategic R&D change

For a considerable time in the past, approval by the U.S. Food and Drug Administration (FDA) was often seen as the “barometer” of the global regulatory system. It was almost the norm that new drugs or new indications would be “first launched in the U.S., followed by other regions.” Yet this time, AstraZeneca’s new indication for trastuzumab deruxtecan was approved first in China—breaking this long-standing convention.

In Jing He’s view, the “global first batch” is not accidental—it marks the beginning of a trend.

She attributes it to “timing, location, and people,” where “timing” comes from the continuous optimization and acceleration of China’s innovative drug review system. Jing He specifically mentioned that under scientific and unmet clinical need–oriented evaluation, CDE has demonstrated a review spirit of “being bold and pioneering.” This spirit is not reckless; it comes from overall confidence rooted in science and data.

“Location” refers to AstraZeneca’s internal R&D strategy and deployment. Years ago, AstraZeneca achieved 100% synchronization between its China R&D pipeline and its global pipeline. This synchronization not only covers pivotal clinical research, but also includes early clinical development stages. This means that China teams are involved from the very beginning in the design and execution of global clinical trials, rather than passively waiting to bridge locally after global data becomes available.

“From the perspective of the overall pipeline deployment, since China joins some global pivotal clinical research plans in sync, it also means that we generate evidence in step with the global timeline to support approval in China.” Jing He said, and this is precisely a key factor behind achieving the “global first batch” in China.

“People” is mainly reflected in the fact that, as AstraZeneca’s China R&D team’s influence in the company’s global R&D network has increased, it has made substantial progress in building global clinical development capabilities, closely following global innovation trends, tightly aligning with China’s real clinical needs, and deep collaboration with top Chinese clinical experts.

According to Jing He, AstraZeneca China’s R&D pipeline projects currently exceed 250, and that number will continue to grow. Taking the DB11 study as an example: it is led in China by Prof. Qiong Wu from Fudan University Shanghai Cancer Center, with the China team participating across the full chain—from overall protocol design to data interpretation.

From achieving global synchronous development, to leading multiple global clinical trials, establishing two global strategic R&D centers in Beijing and Shanghai, and to continuously seeking business expansion opportunities through global licensing collaborations with multiple local innovative pharmaceutical companies, AstraZeneca’s deployment in China has been ongoing for many years.

AstraZeneca Global R&D Beijing Strategic Center

AstraZeneca Global R&D Shanghai Strategic Center

According to publicly available information, since 2023, AstraZeneca has reached 17 cooperation agreements with 15 local Chinese innovative drug companies. These cover cutting-edge technology areas such as cell therapy, ADCs, small molecules, and antibodies. It is understood that more than half of these collaborations are in the oncology field.

In Jing He’s view, behind these collaborations is the rise of local innovative forces in China. She pointed out that in the past few years, a large number of global external licensing collaborations have taken place in China. This is not only a reflection of technical capabilities, but also a result of the rapid development, high maturity, and high efficiency of the entire clinical research ecosystem.

China is becoming a global innovation source for cutting-edge pharmaceutical technologies

Beyond “timing, location, and people,” the deeper meaning of the “global first batch” new indication is that AstraZeneca is building China into a R&D stronghold and a launch market for the next generation of global frontier treatment models. Cutting-edge technologies such as cell therapy, antibodies, radioisotope-conjugated drugs (RDC), and ADCs are enabling end-to-end (End-to-End) deployment here—from the lab to the clinic.

At present, AstraZeneca’s China R&D team has led more than 20 global multi-center clinical trials, covering multiple stages from early to late, involving areas such as gastric cancer, liver cancer, cholangiocarcinoma, lung cancer, cardiovascular disease, and cell therapy. In disease areas that are highly prevalent in China, the China team is evolving from an “executor” into a “leader,” using China’s data to lead global R&D.

Jing He said that the efficiency of China’s clinical research system means faster acquisition of early data, which in turn supports more agile pipeline decisions. Whether it is pushing programs forward or discontinuing them, pipeline competitiveness can be maintained at the global level.

Even earlier, AstraZeneca had already viewed China as a strategic hub for global R&D. Currently, AstraZeneca’s six global strategic R&D centers include two located in China. Among them, the Beijing Global Strategic R&D Center leverages global leading advantages in the science innovation ecosystem and artificial intelligence (AI), and is dedicated to promoting the transformation of early research results, accelerating new drug development, and taking China’s cutting-edge science and innovation achievements to the world.

Jing He divides AI’s impact on R&D into two layers: first, “AI for Science,” with the goal of fundamentally changing the R&D paradigm; second, “AI for Productivity,” using AI to replace a large amount of repetitive manual work and improve efficiency. In her view, the hybrid and systematic new R&D model enabled by AI can coordinate end-to-end data and support global dynamic decision-making. Right before the landing of this new indication’s “global first batch,” AstraZeneca signed a university-level research collaboration agreement with Tsinghua University and announced the establishment of the “Tsinghua University (Institute for Intelligent Industries) — AstraZeneca Artificial Intelligence Drug Discovery Joint Research Center,” focusing on AI-driven drug discovery, translational medicine, and innovative clinical development—promoting research results to accelerate into clinical practice and applications.

Regarding the role positioning of AstraZeneca’s China R&D team, Jing He proposed a three-tier framework: “in China, with China, for Global.” That is: “In China, with China, and for Global,” and these are not progressive relationships but three parallel dimensions that are mutually consistent:

“In China” — Focus on unmet needs of patients in China, enabling seamless access to innovative treatments for Chinese patients, and even letting them receive innovations earlier than patients in other regions of the world.

“With China” — Deeply integrate AstraZeneca’s R&D system with China’s thriving innovation ecosystem, consolidate local innovative resources, and, leveraging strong R&D pipeline capacity, the ability for deep collaboration, and advantages in rapidly advancing clinical development, enable early breakthroughs to be applied to clinical practice more quickly.

“For Global” — Work together with partners to establish a broad network of research collaborations, pushing Chinese innovation and talent onto the international stage. At the same time, it also helps lead Chinese innovation to become an important component within global pipelines, benefiting more global patients.

In addition to multi-dimensional positioning at the R&D end, AstraZeneca is also simultaneously expanding a series of major investments and deployments at the industrial level.

In January this year, AstraZeneca announced plans to invest more than 100 billion RMB in China by 2030 to expand its footprint in drug manufacturing and R&D. Then in March, it announced the establishment of a Shanghai cell therapy commercialization production and supply base and an innovation center, as well as a Guangzhou radioisotope-conjugated drug production and supply base.

These latest deployments since the start of the year, together with two global strategic R&D centers in Beijing and Shanghai and four production and supply bases, further strengthen AstraZeneca’s end-to-end (End-to-End) capability building in China covering the entire “R&D—manufacturing—supply” chain.

“We hope to work more deeply and more broadly with China’s innovative forces—both to solve China-specific disease challenges and to build solutions that benefit patients around the world—Transforming the lives of patients (reshaping patients’ life trajectories).” Jing He said.

Yang Yan / By text

(Editor: Yang Yan, Lin Chen)

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                                                            Medical care