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

Ask AI · Why do global pharmaceutical companies view China as a new global R&D hotspot?

At a critical juncture for the high-quality development of the biopharmaceutical industry, a drug’s “first-in-global” status is no longer just a symbol of review efficiency; it has become a microcosm of the coordinated evolution of the entire industry ecosystem’s development, shifts in regulatory capabilities, and companies’ R&D strategy planning.

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

This event not only marks the successful “front-loading” of the drug’s use from late-line treatment to early-stage treatment; it also makes this new indication the first to be approved in China, becoming “one of the global first batches.”

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

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

Achieving “one of the global first batches” for this indication in China is only a small part of AstraZeneca’s broader presence in China—ranging from the rapid introduction of next-generation frontier therapies (Next Generation Modality) to the localized buildout of end-to-end (End-to-End) full-chain capabilities. This multinational pharmaceutical company is building an innovation closed loop in China that is unprecedented.

A pipeline layout of “all molecular subtypes, all phases”: Priority considerations for clinical needs in breast cancer

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

As a representative of HER2 ADCs, trastuzumab deruxtecan has been taken from DB03 (late-stage, second line) to DB09 (late-stage, first line) for which an application has already been submitted, and then to DB11 (early-stage neoadjuvant). AstraZeneca has not been advancing this series of studies one by one; rather, it has been synchronously planning breast cancer full-course management for years.

He Jing said this “all-line rollout” strategy stems from a basic judgment: the earlier treatment starts, the greater the hope that patients can be cured. We want patients at different stages—whether at initial diagnosis and first treatment, or in recurrence and metastasis—to have the opportunity to benefit from it.

About one-fifth of breast cancer cases are believed to be HER2-positive. For patients with HER2-positive early breast cancer, after conventional neoadjuvant therapy, about half do not achieve pathologic complete response (pCR) and face a relatively high risk of recurrence. The approval of this new indication gives these patients new treatment options and hope for “clinical cure.”

Breast cancer is not a single disease; it is a spectrum that includes molecular subtypes such as HR-positive, HER2-positive, and triple-negative breast cancer (TNBC). Only by delivering precise diagnosis and treatment based on the distinct biological characteristics of different subtypes can we hope to realize the long-term vision of “making cancer no longer the primary cause of death.” AstraZeneca’s deployment in breast cancer is based precisely on a deep understanding of the biological characteristics of different subtypes, and it leverages the advantages of its technology platforms to carry it out. Beyond HER2-positive breast cancer, AstraZeneca also has ample “ammunition” in the other two major subtypes—HR-positive and triple-negative breast cancer—building a rich systemic matrix from “endocrine therapy” to “precision targeted therapy.”

He Jing noted that in terms of R&D priorities, AstraZeneca does not simply weigh “curing patients in the early stage” against “extending survival in the late stage.” Instead, it makes an integrated judgment across three dimensions: strategic value, commercial value, and scientific value. Among these, the core of scientific value is whether it truly addresses unmet clinical needs.

“Now many people are talking about ‘unmet clinical needs.’ Sometimes it sounds like a cliché, but in reality it’s not.” He Jing emphasized, “The truly ‘unmet clinical needs’ hinges on whether we are only solving problems that do not matter to patients, or whether we genuinely improve their quality of life and extend their life span.”

Based on this judgment, AstraZeneca has established several core strategies in global oncology development: fully leveraging its rich product pipeline to explore combination treatments with different modalities such as immunotherapy and ADCs; advancing treatment phases forward—not only in breast cancer, but also rapidly in areas such as lung cancer, urogenital system tumors, and gastric cancer—along with more precise patient selection.

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

From “synchronized” to “one of the global first batches”: An inevitable result of strategic R&D transformation

For a considerable period in the past, approvals from the U.S. Food and Drug Administration (FDA) were often viewed as a “barometer” for the global drug regulatory system. It was almost the norm that a new drug or new indication would be “approved first in the U.S., followed by other regions.” Yet this time, AstraZeneca’s new trastuzumab deruxtecan indication receiving approval first in China breaks that convention.

In He Jing’s view, “one of the global first batches” is not accidental, but the start of a trend.

She attributes it to “timing, location, and people.” “Timing” comes from ongoing optimization and acceleration of China’s innovative drug review system. He Jing specifically mentioned that under a science-driven and clinical-needs-driven framework, CDE has demonstrated review courage to “be bold and take the lead.” This courage is not recklessness—it comes from a solid overall foundation in science and data.

“Location” refers to AstraZeneca’s internal R&D strategy layout. As early as a few years ago, AstraZeneca had already achieved 100% synchronization between its China R&D pipeline and its global pipeline. This synchronization not only covers key clinical studies, but also the early clinical development stage. This means that the China team participates from the very beginning in the design and execution of global clinical trials, rather than passively waiting for global data to be generated and then doing local bridging.

“From the perspective of the overall pipeline layout, because China joins some globally key clinical study plans in sync, it also means that we generate evidence in synchronization with the global effort to support approval in China.” He Jing said. “This is also the key to achieving ‘one of the global first batches’ in China.”

“People” is mainly reflected in the fact that as AstraZeneca’s China R&D team’s voice within the company’s global R&D network has increased, it has made significant progress in building global clinical development capabilities, keeping close to global innovation trends, tightly integrating with China’s real clinical needs, and deeply collaborating with China’s top clinical experts.

According to He Jing, AstraZeneca China’s R&D pipeline projects currently exceed 250, and this number will continue to grow in the future. Taking the DB11 study as an example: it is led in China by Professor Wu Jun of Fudan University Shanghai Cancer Center; the China team participated in full-chain work, from overall protocol design to data interpretation.

From achieving globally synchronized R&D to leading multiple global clinical trials; from establishing two global strategic R&D centers in Beijing and Shanghai; to continuously seeking business expansion opportunities, including establishing global licensing collaborations with multiple local innovative pharmaceutical companies—AstraZeneca’s presence in China has been sustained for years.

AstraZeneca Global R&D Beijing Strategic Center

AstraZeneca Global R&D Shanghai Strategic Center

According to publicly available information, since 2023, AstraZeneca has entered into 17 collaborations with 15 China-based local innovative pharmaceutical companies, covering frontier technology fields such as cell therapy, ADCs, small molecules, and antibodies, and it is understood that more than half of these collaborations are in the oncology area.

In He Jing’s view, behind these collaborations is the rise of China’s local innovative forces. She pointed out that over the past few years, many of the global out-licensing collaborations have taken place in China. This not only demonstrates technical capabilities, but also reflects the rapid growth, high maturity, and very high efficiency of the entire clinical research ecosystem.

China is becoming a global innovation source for frontier medical technologies

Beyond “timing, location, and people,” the deeper significance of a “global first batch” approval for this new indication is that AstraZeneca is building China into a global R&D stronghold and first-launch market for next-generation treatment models. Frontier technologies such as cell therapy, antibodies, radioisotope conjugates (RDC), and ADCs are realizing an end-to-end (End-to-End) layout here—from the laboratory to the clinic.

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

He Jing said that the efficiency of China’s clinical research system means faster acquisition of early data, thereby supporting more agile pipeline decisions. Whether pushing forward or cutting losses, pipeline competitiveness in the global landscape can be maintained.

As early as earlier on, AstraZeneca already regarded China as a strategic R&D foothold globally. Currently, AstraZeneca’s six global strategic R&D centers have two located in China. Among them, the Beijing Global Strategic R&D Center leverages global leading advantages in the scientific innovation ecosystem and artificial intelligence (AI). It is committed to promoting the translation of early research outcomes, accelerating new drug R&D, and bringing China’s frontier science and innovation achievements to the world.

He Jing divides AI’s impact on R&D into two layers: one is “AI for Science,” with the goal of fundamentally changing the R&D paradigm; the other is “AI for Productivity,” using AI to replace a large amount of repetitive human labor to improve efficiency. In her view, the hybrid, systematic new R&D model brought by AI can coordinate full-chain data to support dynamic global decision-making. Just around the time this new indication “one of the global first batches” was rolled out, AstraZeneca signed a university-level research collaboration agreement with Tsinghua University and announced the establishment of the “Tsinghua University (Institute of Intelligent Industries) – AstraZeneca AI Drug Discovery Joint Research Center,” focusing on AI-driven drug discovery, translational medicine, and clinical development innovation, to accelerate research outcomes toward clinical use and application.

Regarding how to position AstraZeneca’s China R&D team, He Jing proposed a three-layer framework of “in China, with China, for Global,” i.e., “In China, with China, to benefit the world.” These are not progressive relationships, but three parallel dimensions that are mutually compatible:

“In China” — focus on unmet needs of patients in China, enabling seamless access for Chinese patients—and even allowing them to obtain innovative treatments ahead of other regions globally;

“With China” — deeply integrate AstraZeneca’s R&D system with China’s flourishing innovation ecosystem, consolidate local innovation resources, and leverage the advantages of a strong R&D pipeline, deep collaboration capabilities, and rapid advancement of clinical development, so that early outcomes can be applied to real clinical practice faster;

“For Global” — work with partners to build a broad research collaboration network, bring China’s innovations and talent to the international stage, and at the same time lead China’s innovation to become an important component within the global pipeline, benefiting more global patients.

In addition to its multi-dimensional positioning on the R&D side, AstraZeneca is simultaneously expanding a series of major investments and in-China deployments on the industry side.

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

Along with these latest deployments at the beginning of the year—together with the Beijing and Shanghai global strategic R&D centers and four production and supply bases—AstraZeneca further strengthens its end-to-end (End-to-End) full-chain capability development in China covering “R&D–manufacturing–supply.”

“We hope to collaborate more deeply and more broadly with China’s innovation strength. We want to address China-specific disease challenges and also build solutions that benefit patients around the world, Transforming the lives of patients (transforming patients’ life trajectories).” He Jing said.

Yang Yan / Text