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Oncology Drug Research, Development, and Manufacturing
Editor's Note:
Multinational Pharmaceutical Companies in a Global PerspectiveIn-Depth Insights —— Innovation, Game Theory, and China's Answers
In the grand narrative of the global pharmaceutical industry's development, multinational pharmaceutical companies have always played a pivotal role—they are explorers at the forefront of science, shapers of most market rules, and crucial participants in the healthcare ecosystems of various countries. From the FDA to the EMA and the NMPA, from mature markets to emerging ones, the strategic choices of multinational pharmaceutical enterprises not only determine their own rise and fall but also profoundly impact the health and well-being of patients worldwide. Within this landscape, the Chinese market is evolving from an "optional choice" to a "must-have option," and further into a "decisive battleground." Its unique policy environment, clinical needs, and innovative potential offer multinational pharmaceutical companies unprecedented opportunities and challenges.
At the same time, the China chapter is undoubtedly a core dimension of this insight. Whether it is integrating China into the global early R&D system, betting on the Chinese market with a "China-first" strategy, or the paradigm shift of local Biotech and MNCs from License-in to License-out, these cases all confirm that multinational pharmaceutical companies' China strategy has evolved from a "scale game" to an "innovation game." Here, you will see how Merck continues to write the "China miracle" with its HPV vaccine and Keytruda; how Novo Nordisk transforms the "blockbuster" weight-loss track into a long-term market advantage; and how giants like AstraZeneca and Roche build innovative ecosystems through BD cooperation...
This column will document the strategic choices of industry leaders, analyze the R&D progress of key pipelines, dissect commercialization strategies, decode the business logic of local collaborations, and observe industry changes under the resonance of policies and markets. We will record the methodologies of successful players while analyzing the cautionary tales of those who stumbled, aiming to provide the industry with truly localized insights within a global framework—interpreting China's opportunities through a global lens and examining corporate decisions from an industry-wide perspective. The series will also illustrate how multinational pharmaceutical companies balance speed and patience, globalization and localization, and scientific rigor with business acumen in China’s vast market.
The change is here, the future has arrived. We look forward to witnessing it with you! (Zhu Ping)
Insights from multinational pharmaceutical companies series:
Author: Joanna
On August 25, Genentech, a U.S. subsidiary of Roche, broke ground on a GLP-1 factory for weight-loss drugs in the United States. Roche stated that it hopes to enter the lucrative weight-loss drug market. Analysts foresee that by 2030, the GLP-1 market will more than double, with the U.S. continuing to lead demand. The initial investment for this project by Genentech is estimated to exceed 700 million U.S. dollars and is part of Roche's commitment to invest 50 billion U.S. dollars in U.S. manufacturing infrastructure and R&D. The facility will create over 1,900 jobs.
In stark contrast, Genentech recently announced the termination of its cell therapy collaboration agreement with Seattle-based biotech company Adaptive Biotechnologies, which was originally valued at up to $2 billion. Despite the project having been a collaborative effort for six and a half years, and the decision not being due to safety concerns, Genentech decided to terminate the project. A spokesperson stated that this decision was based on careful consideration of strategic adjustments.
In recent years, Roche and its subsidiaries have gradually scaled down certain projects, instead focusing on pipelines with greater commercial potential, such as the aforementioned obesity treatment drug field. Since 2025, Roche's "pipeline slimming" has become increasingly evident, with multiple projects in Phase I and Phase III clinical trials being removed, especially the highly anticipated TIGIT antibody.TiragolumabCombination therapies with other drugs have failed in key trials and disappeared from the R&D landscape. Faced with high R&D costs and multiple clinical failures, Roche has chosen to cut its losses in time, freeing up resources to support more promising innovative projects.
From its latest financial report, Roche continues to double down on four core areas: oncology/hematology, immunology, neuroscience, and ophthalmology. Multiple Phase III and registration-stage projects have entered the final sprint stage. Research represented by Tecentriq combination therapies has demonstrated significant survival benefits at the ASCO conference and in The Lancet.LunsumioProducts like Polivy are also awaiting clinical data validation to build a new growth engine.
Like many other multinational pharmaceutical companies, Roche is also adopting a "subtractive approach with one hand" and an "additive approach with the other," cutting early-stage projects that cannot quickly generate profits while increasing investment in pipelines with significant market potential that can be rapidly commercialized. After this series of strategic moves, more answers about the future may emerge in the next earnings season.
01.
"Drastic" Cut in Pipeline
It is reported that the agreement, which was initially launched in January 2019, aimed to help Genentech develop personalized anticancer drugs based on Adaptive’s T-cell receptor (TCR) technology.
Adaptive Receives $300 Million Upfront Payment from This Deal, with Potential Milestone Payments Exceeding $2 Billion. After the Agreement Terminates, Adaptive’s “Exclusive Obligation for Tumor Cell Therapy” Will Be Lifted, Allowing It to Expand Collaborations with Other Institutions.
A Genentech spokesperson stated in a declaration: "We highly value Adaptive's worth as an innovative company and partner, and recognize the efforts both parties have invested in the collaboration over the past six and a half years. As with any decision to terminate a partnership, we proceeded with extreme caution and thorough consideration. This decision was not based on any newly emerging safety concerns."
Before the cooperation termination, Genentech had already initiated layoffs. In June this year, Genentech cut 143 jobs at its headquarters; in July, a second round of layoffs was announced, which would result in the dismissal of another 87 employees from its South San Francisco headquarters.
Genentech responded that the layoffs were "a necessary measure for the company to regularly make adjustments and decisions to appropriately allocate employees across various functional departments."
The suspension of Roche's subsidiary collaboration with Adaptive is no coincidence. In fact, in recent years, Roche has gradually adopted a more cautious attitude towards tumor immunotherapy.
Roche's 2025 Half-Year Report Shows Significant Changes in Q2 Pipeline; Projects Mainly in Early and Mid-Clinical Stages Removed
In Phase I clinical trials, Roche terminated four New Molecular Entities (NMEs): RG6279 (esicafusp alfa ± T) – for the treatment of solid tumors; RG6457 (WRN covalent inhibitor) – a solid tumor therapy targeting the DNA repair-related gene WRN; RG6614 (USP1 inhibitor) – an anticancer small molecule targeting the DNA damage repair pathway; and RG7921 – for the treatment of Retinal Vein Occlusion (RVO).
In Phase III clinical trials, the removed projects were mostly related to immuno-oncology, including: RG6058 (tiragolumab + T) — for unresectableStage III Non-Small Cell Lung Cancer(NSCLC) first-line treatment; RG6058 (tiragolumab + T + Avastin) — for first-line combination therapy in hepatocellular carcinoma (HCC); RG7601 (Venclexta + azacitidine) — for first-line treatment regimen in myelodysplastic syndromes (MDS).
Pipeline adjustment is undoubtedly a concrete manifestation of Roche's resource reallocation.
Take Tiragolumab as an example. The drug targets a protein called TIGIT found on immune cells, a target discovered by a team of scientists at Genentech. This team has been studying the role of TIGIT in suppressing the immune system's anti-cancer response for over a decade.
Tiragolumab, which aims to block inhibitory signals by binding to TIGIT, showed promising results in mid-stage trials and was once considered one of the key assets in Roche's R&D pipeline.
However, since the launch of the pivotal Phase III clinical trials, the drug has faced repeated setbacks, failing to demonstrate that blocking TIGIT therapy offers significant advantages over existing approved immunotherapies such as Tecentriq.
As early as 2022, the Tiragolumab trial for small cell lung cancer failed; a few months later, the SKYSCRAPER-01 trial results showed that the therapy failed to slow tumor progression. Nevertheless, Roche did not immediately abandon development.
In the Q2 2025 report, Roche revealed that the Skyscraper-14/Imbrave-152 trial failed to meet its primary endpoint of progression-free survival (PFS) and did not demonstrate a trend toward overall survival benefit; meanwhile, the Skyscraper-03 study also failed, leading to the removal of Tiragolumab from the company’s R&D pipeline.
For Roche's once highly anticipated immuno-oncology program, this outcome is undoubtedly regrettable.
In terms of external cooperation, Roche has also become more cautious. In August 2025, Roche announced the termination of its oncology research collaboration with Bicycle Therapeutics. The partnership, which was established in 2024, aimed to leverage Flare Therapeutics' proteomics and mass spectrometry platform as well as its proprietary electrophilic compound library to discover novel small-molecule drugs targeting undruggable transcription factors in oncology. As part of the collaboration, Flare Therapeutics would receive a $70 million upfront payment and be eligible for potential discovery, development, and commercialization milestone payments that could exceed $1.8 billion.
In fact, many pharmaceutical companies have joined the "adventure" of TIGIT development: giant companies such as Merck, Bristol-Myers Squibb, Gilead Sciences, as well as smaller firms like Arcus Biosciences and iTeos Therapeutics, have invested heavily in this field.
However, some research results were negative, leading some companies to abandon development. Analysts pointed out that, given recent history, investors are unlikely to maintain high confidence in TIGIT projects within biotech stocks.
The development cost of immunotherapy drugs for advanced tumors is extremely high, with a single Phase III clinical trial potentially costing a huge amount, and failure means significant sunk costs.
According to statistics from relevant oncology pipeline websites, Roche has conducted 12 key Phase II and Phase III studies in the TIGIT field, recruiting nearly 5,000 patients in total. Facing repeated failures, continued investment will increase R&D cost pressures. Timely termination not only avoids repeated losses but also releases funds to support other innovative assets.
02.
Targeting "Promising" Pipeline
While cutting losses in a timely manner, Roche has multiple pipelines poised for development.
As early as the beginning of 2025, Roche CEO Thomas Schinecker pointed out that the company's four core therapeutic areas—oncology/hematology, immunology, neurology, and ophthalmology—are "key focus areas for strengthening the pipeline business development."
The latest financial report once again confirmed this strategy. As of July 24, 2025, the projects in Roche's R&D pipeline that are in Phase III and registration stages exhibit a layout focused on oncology and hematology, while also covering multiple fields such as immunology, neurology, and ophthalmology.
The financial report shows that in the field of oncology/hematology, there are currently eight products involved, including Columvi, Itovebi, Giredestrant, etc., covering multiple high-incidence tumor types and indications. In the fields of immunology, neurology, and ophthalmology, there are four products each in the phase III stage under research.
In the registration and approval stage (in the United States and Europe), multiple projects are ready to go.
Key projects in the oncology field include Tecentriq + Lurbinectedin – for first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC), and the subcutaneous formulation (SC) of Lunsumio for third-line and above recurrent/refractory follicular lymphoma (3L+ FL). In immunology, the registration application for Gazyva for active lupus nephritis (LN) is progressing. In the field of neurology and muscular diseases, the registration for Elevidys for Duchenne muscular dystrophy (DMD) is ongoing. In other areas, the submission work for Xofluza regarding influenza virus transmission suppression is also advancing.
Strengthening key products and late-stage clinical assets will become the most certain growth engine for Roche's future revenue.
Taking Tecentriq as an example, in June 2025, the combination of Tecentriq and Lurbinectedin for the treatment of extensive-stage small cell lung cancer (ES-SCLC) demonstrated significant survival benefits. Roche's official website noted that for patients with malignant tumors who have limited survival time and fewer treatment options, this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%. The first Phase III study on first-line maintenance therapy for ES-SCLC showed clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS). Relevant data were presented at the oral session of the 2025 ASCO Annual Meeting and published in The Lancet.
And the SUNMO trial (Lunsumio +PolivyThe POLARIX trial (combined therapy) and the POLARGO trial (Polivy monotherapy) are also expected to provide supportive data to validate the justification for pricing premiums in markets where survival rate is the highest standard.
On the sales front, Roche said in its Q2 2025 earnings call that it is considering establishing a direct-to-consumer (D2C) sales channel for prescription drugs.
According to reports,D2C ModelRefers to manufacturers or brands selling their self-made products directly to consumers through their own e-commerce websites or social media, without going through wholesalers, retailers, or distributors.
For example, in January 2024, Eli Lilly launched the LillyDirect D2C channel for the treatment of obesity, diabetes, and migraines. Its self-pay pharmacy offers the weight-loss drug Zepbound at a significantly discounted price of $499, which is more than 50% lower than the monthly list price of $1,086.
At the same time, Pfizer, Novo Nordisk, and Bristol-Myers Squibb have successively launched D2C channels.
Roche stated that it has discussed the prospects of the D2C model with U.S. government officials and views it as a way to bypass pharmacy benefit managers (PBMs) who "capture more than 50% of the profits."
Moreover, to address potential tariff risks, Roche plans to invest $50 billion (approximately £37 billion) in the U.S. pharmaceutical industry over the next five years.
Investment projects include the construction of a new gene therapy plant in Pennsylvania, a continuous glucose monitoring plant in Indiana, a weight-loss drug production facility, and the establishment of a cardiovascular, renal, and metabolic research center in Massachusetts. Roche estimates that this investment will create over 12,000 jobs, including 6,500 construction positions and 1,000 positions in newly built and expanded facilities in the U.S.
The aforementioned weight-loss drug manufacturing plant is part of its $50 billion investment project. Genentech stated that it plans to produce GLP-1 obesity treatment drugs, which are still under development, by 2029. Fritz Bittenbender, Senior Vice President of Genentech, also told the media that this plant will become one of the major global suppliers of the product. Prior to this, Novo Nordisk and Eli Lilly have already been producing GLP-1 drugs in the region, and in the future, Genentech will also have to face these two strong competitors.
Although it started late and may face two strong competitors in the future, Roche has also "resolutely" joined the GLP-1 weight-loss army because the market's "prospects" are large enough. IQVIA data shows that since the launch of new GLP-1 agonists in 2021, the sales volume of prescription drugs for obesity has significantly increased. By 2031, the sales of such drugs are expected to exceed $17 billion, with a compound annual growth rate of 15.6% from 2021 to 2031.
Whether it is increasing investment in fields with "profit prospects," cutting early-stage projects, or terminating some external collaborations, Roche's pipeline adjustments are closely related to the broader environment. The current global pharmaceutical industry still faces a complex landscape, influenced by rapidly changing trade and tariff policies. Companies like Roche are implementing relevant strategies to continue focusing on maximizing the value of their product portfolios and driving innovation to strengthen their R&D pipelines. These measures aim to mitigate potential short-term impacts on the business while continuously assessing and formulating opportunities and plans to address long-term tariff effects.