Pfizer's innovative prostate cancer drug has been approved domestically, with plans to introduce over 15 new cancer drugs and indications by 2030 | Directly covering the 2024 Import Expo

Recently, Pfizer announced its growing third-quarter report and raised its full-year performance guidance, with the oncology business segment experiencing the fastest growth, and the anti-cancer business line evolving into a new growth point for Pfizer.

At the 7th China International Import Expo (hereinafter referred to as the "CIIE"), Pfizer's oncology division made its debut in China after a global restructuring of its oncology business.

Wang Yu, Vice President of Pfizer China and General Manager of the Oncology Division, stated, "In the field of oncology, we will focus on science as the core driving force, concentrating on high-incidence and prevalent tumor types in China, such as breast cancer, lung cancer, and urogenital cancers. We plan to launch over 15 new products and indications in the oncology field in China by 2030 to fill clinical treatment gaps."

On the eve of this CIIE, Pfizer's innovative PARP inhibitor Talzenna (talarozole tosylate capsules) for the treatment of prostate cancer was approved in China. Pfizer also showcased its investigational product for the first time—Vepdegestrant (ARV-471), a small molecule PROTAC for endocrine treatment of breast cancer—and announced a series of collaborations to promote the "chronic disease management" of lung cancer.

Accelerating Overtaking in the PARP Inhibitor Track

According to a Frost & Sullivan report, the global PARP inhibitor market is growing rapidly, reaching $2.4 billion in 2020, with an expected compound annual growth rate of 38.3%, projected to reach $12.3 billion by 2025.

Globally, there are 6 approved PARP inhibitors on the market, and in China, 4 PARP inhibitors have previously been approved by the National Medical Products Administration (NMPA).

With the approval of Talzenna on October 29, the domestic market welcomes its 5th PARP inhibitor, which may signify that Pfizer's overtaking in the PARP inhibitor field has entered an acceleration mode.

In June last year, the U.S. FDA approved the oral PARP inhibitor Talzenna in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene mutations.

In January this year, the European Medicines Agency (EMA) also approved Talzenna in combination with enzalutamide for the treatment of adult patients with mCRPC who have no clinical indication for chemotherapy. Enzalutamide is an androgen receptor inhibitor used for the treatment of prostate cancer.

Talzenna has a dual mechanism of action that inhibits PARP enzymes and captures PARP, and its strong combination with enzalutamide brings further breakthroughs in prostate cancer diagnosis and treatment. After its launch abroad, sales data has been impressive, with Pfizer's third-quarter report for 2024 showing a 77% year-on-year growth for the PARP inhibitor Talzenna in the oncology product segment.

Prostate cancer is one of the most commonly diagnosed malignant tumors in men worldwide, with approximately 134,200 new cases and 47,500 deaths in China in 2022. mCRPC is one of the terminal stages of prostate cancer, where patients face the harsh reality of difficult treatment and poor prognosis Professor Ye Dingwei, Vice President of Fudan University Affiliated Tumor Hospital and Director of Shanghai Urological Oncology Research Institute, stated: "With the rapid aging of China's population, prostate cancer has become the most rapidly increasing malignant tumor in incidence among Chinese men. mCRPC is the terminal stage of prostate cancer, characterized by high heterogeneity and lethality, and there is a significant unmet medical need clinically."

The results of the HRR mutation cohort study in the pivotal Phase III trial TALAPRO-2 showed that tolvaptan combined with enzalutamide significantly reduced the risk of disease progression or death by 55%. The approval of tolvaptan in combination with enzalutamide for the treatment of adult patients with mCRPC with HRR gene mutations in China marks a breakthrough in precision diagnosis and treatment of prostate cancer in China, as well as Pfizer's ongoing efforts to accelerate the entry of innovative drugs into China.

"We submit all our products, including registration clinical trials, with the assumption that China is included in the design of all product pipelines. From the perspective of drug submission, we strive to achieve the goal and direction of simultaneous submission and approval in China and globally," said Wang Yu, indicating that Pfizer plans to advance the "China-All-In" strategy for key Phase III and registration submissions across its entire product line.

A New Starting Point for Oncology Business

In December 2023, after spending $43 billion to acquire Seagen, a company specializing in antibody-drug conjugates (ADCs), Pfizer further enriched its product pipeline in the oncology field. According to Pfizer's financial report, in the third quarter of 2024, overall oncology revenue increased by 31% year-on-year. Based on strong performance from the beginning of the year to date, Pfizer also raised its full-year revenue guidance by $1.5 billion, expecting it to be between $61 billion and $64 billion.

Following the substantial acquisition of Seagen, Pfizer reorganized its structure to establish an independent oncology division, setting a goal to focus on four major oncology areas: breast cancer, urogenital tumors, hematological tumors, and thoracic tumors (including head and neck cancer), aiming to have eight blockbuster oncology drugs by 2030 and to double the coverage for cancer patients.

Currently, Pfizer's oncology development strategy is being implemented step by step. In this important market of China, Pfizer has formulated a 3S strategy (Science, Speed, Scale), focusing on research and accelerating the introduction of first-in-class and best-in-class drugs while accumulating scientific data to provide a scientific basis for clinical treatment decisions and policymakers' related decisions, enhancing the standardization, normalization, and homogenization of oncology diagnosis and treatment.

Wang Yu explained that to achieve "3S," it is necessary to cover more cancer types, different stages of a particular tumor, and provide comprehensive management support for patients throughout the entire disease course and in all scenarios.

The patient management support aligns with the major trend of "chronic disease" in oncology.

Pfizer previously announced the five-year follow-up data from the Phase III CROWN study of the world's first third-generation ALK inhibitor lorlatinib, showing that 63% of Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) had not experienced disease progression or death five years later Borui Na is an innovative lung cancer drug that was first showcased at the China International Import Expo five years ago and was approved domestically in 2022.

According to the WHO's definition, diseases with an overall survival rate (OS) exceeding 50% over five years can be considered "chronic diseases."

To promote the "chronic disease" management of non-small cell lung cancer, Pfizer supports the "Non-Small Cell Lung Cancer Patient Disease Management Guidelines (Patient Version)" project initiated by the Beijing Xisike Clinical Oncology Research Foundation in collaboration with the Chinese Society of Clinical Oncology (CSCO) Patient Education Expert Committee at this year's expo.

Additionally, Pfizer supports the ALK-positive NSCLC "clinical cure" project initiated by the China Healthcare International Exchange Promotion Association and has collaborated with Zhejiang University to reach a consensus on exploring the application of digital innovation technologies in the field of oncology.

This year marks the 175th anniversary of Pfizer's establishment and the 35th year since entering the Chinese market. Pfizer has proposed the vision of "Outdo Cancer" globally, aiming to achieve long-term goals in cancer prevention and treatment. Wang Yu stated, "Pfizer hopes to go beyond the drug itself (Beyond the Pill) based on breakthrough innovations, surpassing and defeating cancer at every stage." (This article was first published on the Titanium Media App, author | Yang Yaru)