Recently, the CDE (Center for Drug Evaluation) website showed that Pfizer 's marketing application for zavigipan nasal spray has been accepted, intended for the treatment of adult migraines. This drug is the world's first and only CGRP (calcitonin gene-related peptide) receptor antagonist nasal spray formulation for the treatment of acute migraines.

01
Effective in 15 minutes

Zavegepant is a third-generation, high-affinity, selective small-molecule CGRP receptor antagonist. Initially developed by Bristol-Myers Squibb (BMS), the drug was licensed globally by Biohaven Pharmaceutical from BMS in 2016, which was responsible for its subsequent clinical development, manufacturing, and commercialization. In May 2022, Pfizer acquired Biohaven for approximately $11.6 billion , officially adding Zavegepant to its neuroscience pipeline.

On March 9, 2023, Zavzpret nasal spray became the first CGRP receptor antagonist nasal spray approved by the U.S. FDA for marketing, becoming the world's first approved CGRP receptor antagonist nasal spray for the treatment of acute migraines, breaking the previous pattern of CGRP-targeted drugs being mainly available in oral and injectable formulations.

Among the many CGRP-targeted drugs already on the market globally, the nasal spray formulation of zavigipan has several advantages:

First, it achieves ultra-rapid onset of action. According to the pivotal Phase III clinical trial data upon which Zavegepant's US approval was based, compared to placebo, patients showed significant pain relief within 15 minutes of receiving a single intranasal dose of Zavegepant, regained normal activity function within 30 minutes, and the effect lasted for 48 hours.

Secondly, it addresses the pain points of traditional medication methods, significantly improving patient compliance. Traditional migraine treatments are mostly oral medications. However, some patients experience severe nausea, vomiting, and other gastrointestinal symptoms during acute migraine attacks. In these cases, oral medications are not only difficult to absorb properly but may also exacerbate discomfort due to gastrointestinal irritation, severely impacting treatment effectiveness. Injectable medications, on the other hand, present challenges such as complex administration procedures, patient fear of needles, and inconvenience in carrying them, leading to generally low patient compliance.

Zavigepan is administered via nasal spray, allowing the drug to be absorbed directly through the nasal mucosa, bypassing the gastrointestinal tract and thus avoiding the impact of gastrointestinal symptoms on its efficacy. Furthermore, its operation is extremely simple, allowing patients to administer the medication themselves. The nasal spray device is small, portable, and easy to carry, enabling self-administration anytime. In terms of portability, ease of use, and rapid onset of action, it represents a significant generational advantage over traditional medications. This is particularly suitable for patients with gastrointestinal symptoms, those who cannot tolerate oral medications, or those who require immediate administration, effectively addressing clinical pain points through its dosage form.

02
Pfizer's combined punches

Pfizer's deep involvement in the CGRP target field stems from a series of strategic acquisitions. In November 2021, Pfizer reached an agreement with Biohaven to acquire the commercialization rights of Rimegepant and Zavigepant outside the United States for a total of $1.24 billion, initially completing its layout in the CGRP field. Subsequently, in May 2022, Pfizer further increased its investment by acquiring Biohaven for $11.6 billion, bringing these two core products and their related R&D pipelines under its control, thus establishing Pfizer's core competitive position in the CGRP target field.

Prior to the application for Zavigepan, Pfizer had already successfully introduced another CGRP receptor antagonist, Rimegepant, to the Chinese market, completing the first step in its strategic plan. In January 2024, Pfizer announced that its migraine drug Rimegepant had been approved for marketing in China for the acute treatment of migraines with or without aura in adults. As the world's first and only CGRP receptor antagonist using patented orally disintegrating tablet technology, Rimegepant has been recommended by migraine guidelines in many countries and regions, including the United States, Europe, and China, due to its excellent efficacy. Among them, the "Chinese Guidelines for the Diagnosis and Treatment of Migraine (2022 Edition)" gave it a strong recommendation for use in the acute and preventive treatment of migraines.

Remdesivir orally disintegrating tablets are the first oral CGRP receptor antagonist to demonstrate positive results in a pivotal trial in China. The study showed that after a single oral dose of 75 mg, patients achieved the co-primary endpoint of pain and most bothersome symptom relief within 2 hours. Patients experienced rapid pain relief and elimination of most bothersome symptoms within 45 minutes, restored normal function within 60 minutes, and pain elimination within 90 minutes, with good safety and tolerability.

Remdesivir orally disintegrating tablets were first approved by the FDA in February 2020 for the treatment of acute migraine in adults. In May 2021, its indication was successfully expanded to include the prevention of episodic migraine in adults, making it one of the few CGRP drugs with dual indications for both acute and preventative treatment. Its unique orally disintegrating tablet form eliminates the need for water and dissolves rapidly in the mouth, greatly improving convenience for patients.

According to Pfizer's financial report, Remdesivir orally disintegrating tablets achieved global sales of $1.263 billion in 2024, a year-on-year increase of 36% , accounting for approximately 49% of the oral CGRP drug market, demonstrating strong market growth potential.

To further enhance the accessibility of Remdesivir in China, Pfizer reached a strategic cooperation agreement with AliHealth during the 2025 China International Import Expo. The two parties will conduct in-depth collaboration in the field of migraine treatment, including improving accessibility of innovative drugs, building a digital disease management system, popularizing patient education, and optimizing the entire health service chain, so as to bring patients more convenient and comprehensive treatment support.

Thus, Pfizer's strategy in the migraine field in the Chinese market is now clearly defined: to build a complete solution covering different patient preferences and clinical scenarios through the combination of Remdesivir (orally disintegrating tablets) and Zavigepan (nasal spray). The orally disintegrating tablets are suitable for convenient daily use by most patients, meeting the needs of routine acute migraine treatment and prevention; the nasal spray is used for patients experiencing nausea and vomiting, who cannot tolerate oral medications, or who require extremely rapid onset of action.

This "combination punch" approach not only comprehensively covers the treatment needs of different patients, but also has the potential to help Pfizer build a strong product moat in the increasingly competitive Chinese migraine market, further consolidating its market position in the domestic migraine treatment field.

03
Competitive Landscape

Migraine is a common chronic neurological disorder affecting over 1 billion people worldwide. It is listed by the World Health Organization (WHO) as one of the 10 most disabling medical conditions. While migraines are not life-threatening, their disabling potential is severely underestimated; it is the second leading cause of disability globally, and the leading cause of disability among young women aged 15-49.

Because of the extremely complex mechanisms of migraine, the development of new drugs has long been fraught with challenges. Until 2018, the only drugs specifically designed for migraines were triptans, severely limiting patients' treatment options. In the 1990s, Professor Peter Goadsby of the University of California, San Francisco (UCSF) first discovered that during a migraine attack, the level of calcitonin gene-related peptide (CGRP) in the patient's blood significantly increases, and that CGRP released by the trigeminal nervous system is the "key switch" that triggers a migraine attack. This groundbreaking discovery finally identified the neural source of migraines and made the CGRP signaling pathway a popular target for migraine treatment, opening up a completely new avenue for migraine drug development.

CGRP is a potent vasodilatory neuropeptide composed of 37 amino acids, widely expressed in the central and peripheral nervous systems of mammals. CGRP release levels are significantly increased during migraine attacks, and inhibiting the activity of CGRP and its receptor (CGRPR) can effectively relieve headache symptoms and prevent migraine attacks.

Since the first CGRP-targeted drug was approved in 2018, at least eight related drugs have been launched globally, mainly including two categories: monoclonal antibodies and small molecule receptor antagonists.

In May 2018, Amgen's Erenumab (brand name Aimovig), a monoclonal antibody designed to block the CGRP receptor, was approved for marketing, becoming the first FDA-approved preventative treatment for adult migraines. Clinical data showed a significant efficacy of reducing the number of migraine attack days by 50% in more than 25% of patients treated.

Galcanezumab, a fully human monoclonal antibody developed by Eli Lilly that targets CGRP, was first launched in the United States in September 2018 for the preventive treatment of migraines, under the brand name Emgality. It was approved for marketing in China on January 9, 2024.

Thanks to their long half-life, CGRP monoclonal antibody drugs can be administered monthly or even every three months. As a preventive treatment for migraines, they are effective in reducing the frequency of migraine attacks and the number of headache days, providing a convenient treatment option for patients who need long-term prevention.

Compared to monoclonal antibody drugs, the development of small molecule CGRP receptor antagonists has been more arduous. The development of first-generation small molecule CGRP receptor antagonists was ultimately discontinued due to the potential for liver toxicity with long-term use; second-generation products successfully solved the liver toxicity problem through structural optimization, thus advancing the field.

In December 2019, Ubrogepant was approved for marketing in the United States, becoming the world's first oral CGRP small molecule migraine drug for the acute treatment of migraines. In September 2021, AbbVie's oral CGRP receptor antagonist, Atogepant, received FDA approval, further enriching the landscape of small molecule CGRP drugs.

In terms of global market performance, AbbVie, Eli Lilly, Amgen, and Pfizer account for the vast majority of the global CGRP market share. Among them, Pfizer's Remegapan has seen rapid growth, with global sales reaching $928 million in 2023 and further increasing to $1.263 billion in 2024. AbbVie's Atorgepam, as the first oral prophylactic small molecule CGRP drug, has also performed impressively, with sales growing rapidly from $158 million in 2022 to $658 million in 2024.

The Chinese CGRP antagonist market is still dominated by imported drugs. Pfizer's Remdesivir orally disintegrating tablets (approved in 2024) and Eli Lilly's Galcanezumab injection (approved in 2024) have been successfully launched. Recently, Lundbeck's CGRP-targeted monoclonal antibody Eptinezumab for the preventive treatment of migraines has been officially accepted by the CDE. AbbVie's Atorgepam and other drugs have also entered or are in late-stage clinical trials.

Domestic pharmaceutical companies have relatively few investments in this field. Xiyuan Anjian's BR005 is currently the most advanced domestically produced small-molecule CGRP inhibitor, about to enter Phase III clinical trials. Junshi Biosciences' JS010 is a recombinant humanized anti-CGRP monoclonal antibody injection, mainly used for the preventative treatment of adult migraines, and received NMPA clinical trial approval in March 2023.
From the perspective of the competitive landscape in the global and Chinese markets, the focus of competition in the CGRP antagonist field has gradually become clear, mainly concentrated on two core dimensions: dosage form innovation and indication expansion .

In terms of dosage form innovation , currently available CGRP antagonists cover a variety of dosage forms, including oral tablets, orally disintegrating tablets, nasal sprays, and injections. Companies are continuously optimizing administration methods to match the needs of different patients, improve patient compliance, and thus capture niche markets. In the future, with the continuous advancement of pharmaceutical technology, it is expected that more novel dosage forms, such as transdermal patches, will emerge, further enriching the options for migraine treatment and driving market competition towards greater refinement.

Regarding the expansion of indications , the main indications for CGRP antagonists are currently focused on the acute treatment or preventative treatment of migraines. To further expand the market, many companies have begun to plan for expanding indications. For example, Eli Lilly's Galcanezumab has been approved for the treatment of paroxysmal cluster headaches in adults, successfully expanding its market application.

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