主要目的：比较空腹和餐后给药条件下，远大医药（中国）有限公司提供的玛巴洛沙韦片（规格：20 mg）与RochePharma（Schweiz）AG持证的玛巴洛沙韦片（商品名：Xofluza®/速福达®；规格：20 mg）在中国健康人群吸收程度和吸收速度的差异。次要目的：评价空腹及餐后条件下，远大医药（中国）有限公司提供的玛巴洛沙韦片（规格：20 mg）与RochePharma（Schweiz）AG持证的玛巴洛沙韦片（商品名：Xofluza®/速福达®；规格：20 mg）在健康研究参与者体内的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of Mabaloxavir Tablets (20 mg) provided by Grand Pharmaceuticals (China) Co., Ltd. and Mabaloxavir Tablets (trade name: Xofluza®/Sufuda®; specification: 20 mg) licensed by RochePharma (Schweiz) AG in healthy Chinese population under fasting and fed conditions. Secondary objective: To evaluate the safety of Mabaloxavir Tablets (20 mg) provided by Grand Pharmaceuticals (China) Co., Ltd. and Mabaloxavir Tablets (trade name: Xofluza®/Sufuda®; specification: 20 mg) licensed by RochePharma (Schweiz) AG in healthy study participants under fasting and fed conditions.

Start Date03 Mar 2025

Sponsor / Collaborator

Grand Pharmaceutical (China) Co., Ltd.

NCT06762587

/ Not yet recruitingNot ApplicableIIT

A Randomized, Open-Label Clinical Study on the Efficacy of Baloxavir Marboxil and Oseltamivir for Post-Exposure Prevention of Influenza in a Hospital Setting

This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.

Start Date05 Jan 2025

Sponsor / Collaborator

Capital Medical University

[+2]

NCT06653569

/ RecruitingPhase 3IIT

A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza

The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study.
The main questions are:
1. When someone is hospitalized with a severe influenza infection, does baloxavir help to reduce the time needed to recover?
2. Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu?
3. Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu?
4. Can baloxavir reduce duration of contagiousness?
To be able to measure the above, the investigators will compare two groups of patients: One group receiving baloxavir marboxil, the other group receiving a mock treatment called placebo.
Participants will:
* Take one single dose of baloxavir marboxil or placebo soon after hospitalization.
* Vital signs will be followed three times per day during hospital stay.
* Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation.
* Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment.

Start Date01 Dec 2024

Sponsor / Collaborator

Les Hôpitaux Universitaires de Genève

[+5]

100 Clinical Results associated with Baloxavir Marboxil

100 Translational Medicine associated with Baloxavir Marboxil

100 Patents (Medical) associated with Baloxavir Marboxil

489

Literatures (Medical) associated with Baloxavir Marboxil

31 Dec 2025·Emerging Microbes & Infections

Influenza H5Nx viruses are susceptible to MEK1/2 inhibition by zapnometinib

Article

Author: Beer, Martin ; Brunotte, Linda ; Kumar, Sriram ; Ludwig, Stephan ; Oberberg, Nicole ; Caliskan, Duygu Merve ; Schreiber, André ; Rodner, Franziska ; Ambrosy, Benjamin

Highly pathogenic avian influenza A viruses (HPAIV) pose a significant threat to both animal and human health. These viruses have the potential to cause severe respiratory and systemic infections in birds and several mammalian species. The recent global outbreak of the H5N1 clade 2.3.4.4b spread in wild and domestic birds is now considered to be a panzoonosis. Spillover events in dairy cattle farms in the U.S. have highlighted the urgent need for effective antiviral therapies, especially in view of human infections. This study investigates the selective MEK1/2 inhibitor zapnometinib (ZMN) as a potential antiviral agent against HPAIVs. Our in vitro experiments demonstrate that ZMN significantly impairs viral replication across multiple HPAIV strains, including H5N1 clade 2.3.4.4b in cell lines and primary bronchial epithelial cells. The mechanism of action is based on the nuclear retention of newly produced viral ribonucleoprotein complexes (vRNP), when the MEK/ERK/RSK1 kinase cascade is inhibited. We furthermore could show, that ZMN not only acts antiviral in a standalone treatment but has synergistic potential when used in combination with direct-acting antivirals like oseltamivir or baloxavir. Therefore, ZMN treatment offers a promising strategy for future antiviral development.

01 Jul 2025·JOURNAL OF PEDIATRICS

Factors Associated with Antiviral Drug Use Among Commercially Insured Children at High Risk for Complications of Influenza

Article

Author: Grijalva, Carlos G ; Abdelaziz, Abdullah ; Lee, Todd A ; Williams, Derek J ; Lien, Pei-Wen ; Antoon, James W ; Sarker, Jyotirmoy

OBJECTIVES:

To evaluate the prevalence of antiviral drug use in children in the US with influenza at high risk for complications and to identify factors associated with dispensing.

STUDY DESIGN:

We conducted a retrospective cohort study of outpatient visits for individuals < 18 years during the 2016-2020 influenza seasons using the Merative MarketScan Commercial Claims and Encounter database. High-risk status was defined using Infectious Disease Society of America definitions and included: age, specific comorbidities, pregnancy or postpartum status, and living in a long-term care facility. The primary outcome was antiviral (oseltamivir, zanamivir, baloxavir) dispensing within 2 days of influenza diagnosis. We determined clinical factors associated with antiviral dispensing using modified Poisson regression.

RESULTS:

A total of 372 372 influenza episodes were identified among 331 389 children at high risk for influenza complications and included in this study. The median (IQR) age was 4.0 years (2.0, 9.0). Overall, during 201 638 (54.1%) episodes of the influenza, antiviral treatment was dispensed. Factors associated with increased antiviral use included asthma, West and South US geographic regions, urgent care settings, and specific health insurance plans. Factors associated with decreased antiviral use include younger age, emergency department setting, Midwest and Northeast geographic regions, and health insurance plans.

CONCLUSION:

Despite national guidelines recommending that all children at high risk for influenza complications receive antiviral treatment, nearly half of these children at high-risk did not receive an antiviral in our study. We identify several factors associated with decreased antiviral treatment that may serve to inform future interventions aiming to improve the care of vulnerable children with influenza.

01 Jun 2025·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Design, synthesis, and activity evaluation of C-8 arylated luteolin derivatives as influenza endonuclease inhibitors

Article

Author: Kožíšek, Milan ; Majer, Pavel ; Reiberger, Róbert ; Tsalyy, Artem ; Machara, Aleš ; Konvalinka, Jan ; Kráľ, Michal

The polymerase acidic (PA) subunit of the influenza virus, an endonuclease of the RNA-dependent RNA polymerase, represents a viable target for anti-influenza therapies, as evidenced by the efficacy of the FDA-approved drug Xofluza. A characteristic feature of endonuclease inhibitors is their ability to chelate Mg²⁺ or Mn²⁺ ions within the enzyme's catalytic site. Previously, our studies identified luteolin and its C-8-glucoside orientin as potent endonuclease inhibitors. This report details our subsequent investigation into the structural modifications of the phenyl moiety attached to the C-8 position of luteolin. The inhibitory potencies (IC₅₀ values) quantified with AlphaScreen technology indicated that substituting the C-8 glucose moiety of orientin resulted in compounds with comparable inhibitory potency. From a series of eighteen compounds, acid 12 with 3-carboxylphenyl moiety at the C-8 position was the most potent inhibitor with nanomolar potency.

News (Medical) associated with Baloxavir Marboxil

07 May 2025

·www.shionogi.com

Announcement of Agreement on Company Split (Simplified Absorption-Type Split) of Japan Tobacco Inc.'s Pharmaceutical Business and Acquisition of Shares of Akros Pharma Inc. by Shionogi Inc. (Making it a Subsidiary)

OSAKA, Japan, May 7, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi" or the “Company”) today announced that at the Board of Directors meeting held on May 7, 2025, it resolved to succeed to the pharmaceutical business of Japan Tobacco Inc. (Headquarters: Minato-ku, Tokyo; President: Masamichi Terabatake; hereinafter referred to as "Japan Tobacco") (hereinafter referred to as "JT Pharmaceutical Business" or the "Business to be Split") through a company split (simplified absorption-type split) (hereinafter referred to as the "Absorption-Type Split") and to acquire all issued shares of Akros Pharma Inc. (a 100% sub-subsidiary of Japan Tobacco, headquartered in New Jersey, USA; hereinafter referred to as "Akros") by Shionogi Inc., a group company of Shionogi in the USA (hereinafter referred to as the "Share Acquisition"), and has entered into an agreement (hereinafter referred to as the "Agreement") regarding the same. In connection with the Agreement, the Company also resolved at the Board of Directors meeting held today to conduct a tender offer (hereinafter referred to as the "Tender Offer") for the common shares of Torii Pharmaceutical Co., Ltd. (hereinafter referred to as "Torii Pharmaceutical"), a consolidated subsidiary of Japan Tobacco, to make Torii Pharmaceutical a wholly-owned subsidiary of the Company (hereinafter referred to as the "Full Ownership"). For details on the Tender Offer, please refer to the "Notice of Commencement of Tender Offer for Shares of Torii Pharmaceutical Co., Ltd. (Securities Code: 4551)" released today. I. Purpose of the Absorption-Type Split and Share Acquisition (hereinafter referred to as the "Transaction") Shionogi's basic policy (SHIONOGI Group Heritage) is to always provide the best medicine (healthcare solutions) necessary to protect people's health. The Company engages in research and development, manufacturing, and sales activities of prescription drugs, over-the-counter drugs, and diagnostic agents. In 2020, the Company set forth the Vision (SHIONOGI Group Vision) that aims to achieve by 2030, "Creating the Future of Healthcare with a New Platform," and formulated the medium-term management plan Shionogi Transformation Strategy 2030 (STS2030) to realize this Vision. The Company is transforming into a Healthcare as a Service (HaaS) company that provides various healthcare services tailored to customer needs, not limited to the provision of prescription drugs, to comprehensively address the problems faced by patients and society worldwide. From fiscal 2020 to fiscal 2022, the Company aimed to contribute to the early end of the COVID-19 pandemic by providing not only therapeutic drugs but also total care solutions for COVID-19, including detection (epidemic prediction), prevention, diagnosis, and mitigation of severe cases. As a result, the Company obtained domestic approval for the COVID-19 therapeutic drug Xocova at an unprecedented speed, advancing its drug discovery capabilities. Additionally, the Company expanded its product and service offerings beyond prescription drugs, including its first vaccine and wastewater epidemiology survey service. Based on the achievements and lessons learned from these efforts, the path to realizing the SHIONOGI Group Vision became clearer, leading to the revision of STS2030 in 2023 and the start of STS2030 Revision. In STS2030 Revision, the three years from fiscal 2023 to fiscal 2025 are positioned as STS Phase 2, with the basic policy of global top-line growth centered on the infectious disease area and fostering growth drivers through aggressive investment, accelerating growth through transformation. In research and development, the Company focuses on high-impact infectious diseases and high-impact QOL diseases as priority areas. In infectious diseases, the Company has developed many innovative new drugs, such as the anti-HIV drugs (dolutegravir and cabotegravir), the for multidrug-resistant Gram-negative bacterial infections (cefiderocol), and the anti-influenza virus drug Xofluza, based on its strong foundation in small molecule drug discovery (creating drugs with molecular weights ranging from tens to hundreds). The Company aims to solve the problems faced by patients and society worldwide by further strengthening and expanding its strong foundation in small molecule drug discovery. On the other hand, JT Pharmaceutical Business has been engaged in research and development of prescription drugs since entering the business in 1987, aiming to create first-in-class small molecule drugs through stable research and development investment. Currently, under the business purpose of "valuing science, technology, and human resources and contributing to patients' health," Japan Tobacco conducts research and development, while Torii Pharmaceutical handles manufacturing, sales, and promotion activities, building an integrated value chain and maximizing synergies within the group. JT Pharmaceutical Business focuses on three priority research and development areas: cardiovascular, renal, and muscle, "immunology and inflammation, and central nervous system, with strengths in rapid clinical development through specialization on research and development in the small molecule drug discovery and collaboration between domestic and international research and development bases. To deliver new drugs created in-house to patients as early as possible, JT Pharmaceutical Business actively engages in out-licensing and partnerships with global mega-pharma companies, in addition to promoting in-house development. Shionogi has been considering collaboration with JT Pharmaceutical Business and Torii Pharmaceutical to realize the Vision of "Creating the Future of Healthcare with a New Platform" in STS2030 Revision. As a result of these considerations, the Company concluded that by adding the capabilities of JT Pharmaceutical Business, which has strengths in small molecule drug discovery and development , it would be possible to accelerate the advancement of promising pipeline projects and increase the responsiveness and efficiency of business operations through collaboration with the Company's pharmaceutical manufacturing functions. The Company proposed to Japan Tobacco the acquisition of JT Pharmaceutical Business and the full ownership of Torii Pharmaceutical, and after subsequent discussions, reached the Agreement. The Company believes that the Transaction will create a leading company that delivers innovative pharmaceuticals from Japan to the world, contributing to the health of patients and people worldwide, and contributing to the realization of a sustainable and healthy society. The Company also believes that the Transaction will provide opportunities for the employees of JT Pharmaceutical Business (including group companies) to continue to thrive with peace of mind. II. Overview of the Absorption-Type Split i. Summary of the Absorption-Type Split (1) Date (1) Date of Board Resolution for Agreement May 7, 2025 (2) Date of Agreement May 7, 2025 (3) Date of Board Resolution for Absorption-Type Split Agreement September, 2025 (planned) (4) Date of Absorption-Type Split Agreement September, 2025 (planned) (5) Effective Date of Absorption-Type Split December, 2025 (planned) (Note 1): The Absorption-Type Split falls under the simplified absorption-type split stipulated in Article 796, Paragraph 2 of the Companies Act for the Company, and Article 784, Paragraph 2 of the Companies Act for Japan Tobacco. Therefore, it will be carried out without the approval resolution of the shareholders' meeting. (Note 2): The schedule may be changed as necessary, considering the need for responses to approvals, registrations, notifications, etc., from relevant authorities, circumstances, and other various factors. (2) Method of Absorption-Type Split The Company will be the succeeding company, and Japan Tobacco will be the splitting company. (3) Allocation of Consideration The Company will pay 5,397 million yen to Japan Tobacco as consideration for the Absorption-Type Split. (4) Handling of Stock Acquisition Rights and Bonds with Stock Acquisition Rights Not applicable. (5) Increase or Decrease in Capital Due to Absorption-Type Split Not applicable. (6) Rights and Obligations to be Succeeded The Company will succeed to the assets, liabilities, and contractual rights and obligations related to the Absorption-Type Split, except for those separately specified in the Absorption-Type Split Agreement. (7) Prospects for Debt Performance The Company believes that there are no issues with performance of the debts that will become due after the effective date of the Absorption-Type Split. ii. Allocation of Consideration and Basis for the Absorption-Type Split (1) Basis and Reason for Allocation of Consideration The allocation of consideration was agreed upon after comprehensive discussions between both companies, taking into account the performance status and future prospects of the business to be split. (2) Matters Related to Calculation The Company has not obtained a valuation report from a valuation institution in connection with the Absorption-Type Split. (3) Prospect of Delisting and Its Reason Since the consideration involves the exchange of money, there is no prospect of delisting. (4) Measures to Ensure Fairness Not applicable. However, the Company has appointed Nishimura & Asahi Law Office as the legal advisor for the Absorption-Type Split and has received legal advice on various procedures, decision-making methods, and processes related to the Absorption-Type Split. Nishimura & Asahi Law Office does not have any significant interests that should be disclosed in relation to the Absorption-Type Split and is not a related party to the Company or Japan Tobacco. (5)Measures to Avoid Conflicts of Interest Not applicable. (Unit: million yen, unless otherwise specified.) i. Overview of JT Pharmaceutical Business (1) Content of JT Pharmaceutical Business Research and development of prescription drugs (2) Business Performance of JT Pharmaceutical Business Fiscal year ended December 2024 Net sales ¥44,942 million (3) Items and Amounts of Assets and Liabilities of the JT Pharmaceutical Business to be Succeeded (as of December 31, 2024) The assets (excluding shares of Torii Pharmaceutical and Akros) and liabilities, as well as other rights and obligations belonging to the JT pharmaceutical business, As stipulated in the absorption-type split agreement will be succeeded by our company. Assets Liabilities field book value field book value Current Assets ¥8,588 million Current Assets ¥5,448 million Fixed Liabilities ¥37,832 million Fixed Liabilities ¥9,875 million Total ¥46,420 million Total ¥15,323 million Note: The above amounts are calculated based on the balance sheet as of December 31, 2024, and the actual amounts to be succeeded will be adjusted for any increases or decreases up to the effective date. ii. Status After the Absorption-Type Split (1) Name of Company Shionogi & Co., Ltd. Japan Tobacco Inc. (2) Location 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan 1-1, Toranomon 4-chome, Minato-ku, Tokyo (3) Representative Isao Teshirogi, Ph.D., Representative Director, President and CEO Masamichi Terabatake, President, Chief Executive Officer and Representative Director　 (4) Business Description Research, development, manufacturing and distribution of pharmaceuticals, diagnostic reagents and medical devices, etc. Manufacture, sale, import, etc., of manufactured tobacco (5) Paid-in Capital ¥21,279 million ¥100,000 million (6) Fiscal Year-End March 31 December 31 (7) Net Assets It is not confirmed at this time It is not confirmed at this time (8) Total Assets It is not confirmed at this time It is not confirmed at this time iii. Overview of Accounting Treatment For the accounting treatment related to the Absorption-Type Split, we plan to apply IFRS 3 'Business Combinations' and use the purchase method, with our Company as the acquiring entity. The amount of goodwill generated from this Absorption-Type Split is currently undecided, and we will inform you as soon as it is determined. iv. Future Outlook We are currently assessing the impact of this Absorption-Type Split on our consolidated performance, and will inform you as soon as it is determined. v. Other Noteworthy Matters The Agreement is contingent upon the absence of any factors hindering the execution of the stock acquisition, such as the issuance of a cease and desist order, based on the results of the Japan Fair Trade Commission's review of the notification under Article 10, Paragraph 2 of the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade. II. Overview of this Stock Acquisition i. Overview of Our U.S. Subsidiary (Shionogi Inc.) Acquiring the Shares (1) Name of Company Shionogi Inc. (2) Location 400 Campus Drive, Florham Park, NJ 07932, USA (3) Representative President and Chief Executive Officer Nathan McCutcheon (4) Business Description Development, manufacturing, and sales of pharmaceuticals (5) Paid-in Capital 12 USD (as of March 31, 2024) (6) Date of Founding August 2008 (7) Major Shareholders and Shareholding Ratios Shionogi (100%) ii. Overview of the Subsidiary to be Acquired (1) Name of Company Akros Pharma Inc. (2) Location 302 Carnegie Center, Suite 300, Princeton, NJ 08540 (3) Job Title and Name of Representative President＆CEO Teppei Higuchi (4) Business Description Clinical development, joint research, and exploration of new technology projects overseas (5) Paid-in Capital 1,000 USD (as of December 31, 2024) (6) Date of Founding January 1999 (7) Net Assets 23,776 thousand USD (as of December 31, 2024) (8) Total Assets 32,986 thousand USD (as of December 31, 2024) (9) Major Shareholders and Shareholding Ratios JT AMERICA INC. (100%) ※ JT AMERICA INC. is a wholly owned subsidiary of Japan Tobacco Inc. (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Transactional Relationship None. Status as Related Party None. iii. Overview of the Counterparty in the Stock Acquisition (1) Name of Company JT AMERICA INC. (2) Location 112 W. 34th Street, 18th Floors, New York, NY 10120 (3) Job Title and Name of Representative President & CEO Toshimitsu Eguchi (4) Business Description Holding company functions in the U.S. for non-tobacco and non-food businesses (5) Paid-in Capital 51 thousand USD (as of December 31, 2024) (6) Date of Founding May 1988 (7) Net Assets 141,447 thousand USD (as of December 31, 2024) (8) Total Assets 142,125 thousand USD (as of December 31, 2024) (9) Major Shareholders and Ownership Ratios Japan Tobacco Inc.(100％) (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Business Relationship None. Related Party Relationship None. iv. Number of Shares to be Acquired, Acquisition Price, and the Status of Shareholding Before and After the Acquisition * The acquisition price has been converted at an exchange rate of 1 USD = 151.55 JPY (based on the average rate over the past six months). v. Date vi. Future Outlook We are currently assessing the impact of this stock acquisition on Shionogi’s consolidated financial results for the fiscal year ending March 2026. If it becomes necessary to revise the performance forecast, Shionogi will promptly disclose the information. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

AcquisitionLicense out/in

28 Apr 2025

·endpts.com

European regulators recommend new drugs from Vertex, Amgen and Jazz

Vertex Pharmaceuticals, Amgen and Jazz Pharmaceuticals are among companies that received a positive opinion from European regulators for drugs that are already in the US market. The European Medicines Agency’s human medicines committee (CHMP) said on Friday that it recommended the European Commission to give the go-ahead for six new medicines and 10 label expansions. Among the six new medicines was Vertex’s cystic fibrosis oral therapy called Alyftrek, which was approved by the FDA last December for the same indication. Amgen similarly got a CHMP nod for Tepezza in moderate to severe Thyroid Eye Disease. Tepezza was approved by the FDA for that condition in January 2020. Jazz also secured a positive opinion for its bile duct cancer antibody Ziihera, which was approved by the FDA in November last year. On Friday, the committee said it would re-examine its earlier decision to reject Eli Lilly’s Alzheimer’s drug Kisunla. It also recommends PTC Therapeutics’ drug, dubbed Sephience, to be used to treat hyperphenylalaninemia in patients with the metabolic disease phenylketonuria. The other CHMP medicine recommendations are for Italfarmaco’s therapy Duvyzat for Duchenne muscular dystrophy and Purpose Pharma’s Attrogy for ATTR amyloidosis. As for the 10 label expansions, the committee recommended extending two of Bayer’s drugs, including a new dose of Adempas, which is approved for pulmonary arterial hypertension, as well as extending the label for the hemophilia A drug called Jivi for children aged seven and above. Other label recommendations: The regulators also recommended the EC approve nine new biosimilar products, eight of which were biosimilars to Amgen’s denosumab, which is a treatment for rare bone disease.

Drug Approval

27 Apr 2025

·synapse.patsnap.com

Innovation vs. Accessibility: Lessons from the Roche-CSPC Patent Dispute

In April 2021, Swiss pharmaceutical giant Roche celebrated the approval of its novel anti-influenza drug, Baloxavir Marboxil, in China. As the world’s first single-dose oral influenza treatment, Baloxavir quickly captured industry attention with its disruptive convenience and rapid symptom relief. However, Roche’s victory was short-lived. Just three months later, CSPC Ouyi Pharmaceutical, a subsidiary of Chinese pharmaceutical powerhouse CSPC Pharmaceutical Group, filed an application to launch a generic version, directly targeting Roche’s core patent. This confrontation not only marked Roche’s first major intellectual property battle in the Chinese market but also became the most high-profile test case under China’s newly implemented patent linkage system. The unfolding conflict around Baloxavir reveals deeper tensions between innovation protection and generic competition within China’s pharmaceutical sector — and its outcome could fundamentally reshape the competitive landscape for years to come. The Patent Linkage Challenge: A Carefully Orchestrated "Head Start" Baloxavir’s rapid rise was fueled by its groundbreaking efficacy. As the first single-dose oral antiviral for influenza, it inhibits the virus’s RNA polymerase, offering significant symptom relief within 24 hours — a sharp contrast to the traditional five-day course required by oseltamivir. In 2021, Roche successfully secured Baloxavir’s inclusion in China's National Reimbursement Drug List (NRDL) at a negotiated price of RMB 718 per box, bringing the out-of-pocket cost for patients down to around RMB 200. This pricing move helped Baloxavir swiftly penetrate the market, with sales surpassing RMB 1.2 billion by 2022, making it one of Roche’s fastest-growing innovative therapies in China. However, the glow of early success was soon dimmed by CSPC’s bold move. In July 2021, merely three months after Baloxavir’s approval, CSPC Ouyi filed for marketing authorization of its generic version. Leveraging China’s Interim Measures for the Early Resolution Mechanisms for Drug Patent Disputes, CSPC submitted a Category IV certification — formally challenging the validity or infringement of Roche’s patent. This filing triggered the core mechanism of the patent linkage system: Roche had 30 days to initiate a lawsuit, while CSPC sought to seize the highly coveted "first generic" opportunity. If successful, CSPC stood to win an enormous commercial advantage — participating in centralized procurement programs (volume-based procurement) and selling at 50%–70% discounts compared to the originator, potentially achieving sales of up to RMB 800 million in the first year alone. Meanwhile, Roche faced the grim prospect of its market share shrinking below 30%. At the heart of the legal battle lies the dispute over patent validity and infringement. Roche asserted that CSPC’s generic infringed upon its compound patent (ZL201180056716.8), which covers both the molecular structure and manufacturing processes of Baloxavir, with protection extending until 2031. Under China’s system, Roche’s lawsuit triggered a nine-month stay on regulatory approval — much shorter than the 30-month stay period typical in the United States. As a result, by October 2022, CSPC’s generic was approved even though the litigation remained unresolved. Roche promptly sought a preliminary injunction and damages, but the court has yet to issue a final ruling, leaving the case mired in a complex technical and legal deadlock. A Market and Legal Duel: Racing Against a Multi-Billion-Dollar Clock Beyond the courtroom, the stakes are enormous. China records approximately 30–50 million influenza cases annually, creating an antiviral market exceeding RMB 5 billion. Thanks to its single-dose convenience, Baloxavir was positioned as a "market disruptor." Roche’s strategy hinged on extending exclusivity through litigation while maximizing market penetration via reimbursement coverage. Its strong sales in 2022 owed much to rapid uptake after NRDL inclusion. However, should CSPC's low-cost generic win a centralized procurement bid, it could deal a significant blow to Roche’s premium pricing model. Historically, generic entry in centralized procurement schemes has slashed drug prices by 50% or more. Given influenza’s massive patient base and wide insurance coverage in China, the pricing pressure on originators could be especially severe. For CSPC, the motivations run deeper than immediate profits from Baloxavir. As a leading player in China’s generics market, CSPC is positioning itself for the next phase of competition — the era of "hardcore generics," which involve challenging complex, high-value patents, including those for PD-1 inhibitors and CAR-T therapies. Victory in this case would provide invaluable experience and pave the way for broader ambitions. Meanwhile, Roche’s predicament reflects a broader anxiety among multinational pharmaceutical companies. With China’s patent linkage system encouraging more aggressive "patent challenges," originators must now build robust “patent thickets” or risk falling off a "patent cliff" as generics penetrate their once-secure markets. The procedural complexity continues to grow. CSPC may seek to invalidate Roche’s patent at the China National Intellectual Property Administration (CNIPA). If successful, Roche’s infringement claims could collapse entirely. The infringement analysis itself demands granular comparison between CSPC’s manufacturing processes and Roche’s patent claims, spanning issues such as molecular structure, crystalline form, and formulation components. CSPC could argue that it uses a different crystalline form or excipients to circumvent the patent — but such arguments would require both experimental evidence and legal substantiation. Adding to Roche’s dilemma is a unique feature of China’s system: generics can be approved and launched even while litigation is ongoing. This “market lost before litigation resolved” scenario poses significant risks. Even if Roche ultimately wins in court, it may struggle to recapture market share once prescribers and patients become accustomed to the generic alternative. Industry Shockwave: China's "Stress Test" for Innovative Drug Protection This case is more than just a showdown between Roche and CSPC Pharmaceutical Group—it is a true "stress test" for China’s pharmaceutical patent protection system. The Implementation Measures for Early Resolution Mechanisms for Drug Patent Disputes (Trial) were designed to balance innovation incentives with the accessibility of generics, aiming to avoid the kind of "patent cliff" collapses seen in the U.S. market. However, disputes in practice have already emerged: Is the 9-month waiting period too short? Does allowing generics to launch during pending infringement lawsuits lead to a scenario of "winning the case but losing the market"? The answers to these questions will directly shape multinational companies' strategies in China and influence domestic companies’ approaches to generic drug development. For multinational pharmaceutical companies, this case highlights vulnerabilities in Chinese patent strategies. Roche’s baloxavir marboxil only had core compound patent protection, with insufficient coverage of critical aspects like crystal forms and formulation processes—leaving room for generic circumvention. Moving forward, companies like Roche may pivot to a "patent thicket" strategy, applying for multi-dimensional protections (e.g., crystal forms, manufacturing processes, combination therapies) to build a more comprehensive defense. At the same time, more flexible use of legal tools will become essential: beyond infringement litigation, Roche could file antitrust complaints alleging market abuse by CSPC, or demand disclosure of CSPC’s R&D data to exert additional pressure. Domestic pharmaceutical companies, on the other hand, will need to upgrade their generic strategies. CSPC’s “blitzkrieg” approach was strategically bold but carries significant risk—should they lose the case, they could face sales bans, financial compensation claims, and disruptions to the approval of other generic products. In the future, generics companies will need to conduct preemptive risk assessments, assemble "patent challenge expert teams," and even consider settlement agreements with originator companies (such as paying a 5–15% royalty share) to minimize legal conflict. This mirrors the U.S. model, where generics often negotiate "pay-for-delay" settlements, a practice whose viability in China will depend heavily on evolving judicial attitudes. Regulatory reflection is already underway. The National Medical Products Administration (NMPA) may consider extending the patent linkage waiting period or introducing mechanisms like compulsory recall of infringing products to strengthen protections for originator companies. The verdict in this case will provide a critical precedent: a win for Roche could boost multinational companies' confidence in China’s IP system and accelerate the introduction of innovative therapies; a win for CSPC could trigger a wave of patent challenges from generics, forcing originators to strengthen their patent fortifications. This case could also catalyze revisions to China's Patent Law, clarifying the boundaries of patent circumvention for generics and reducing ambiguities in legal interpretation. Future Outlook: A "Butterfly Effect" That Could Redefine the Industry The ultimate outcome of this case will deeply influence the landscape of China’s pharmaceutical sector. If Roche wins, CSPC’s baloxavir marboxil generic could be banned, with CSPC liable for damages and R&D cost losses—a cautionary tale for generics challenging high-value patents. Roche, in turn, could establish a tough enforcement image, deterring future challengers and prolonging market exclusivity for its patented drugs. However, a more likely scenario is a settlement: CSPC agreeing to pay royalties in exchange for market access. Such a "win-win" model could offer a blueprint for future generic launches against complex patents—securing returns for innovator companies while providing legitimate expansion paths for generics. Regardless of the outcome, the case has already exposed a fundamental tension within China's pharmaceutical industry: the clash between the long-term value pursuit of innovators and the short-term accessibility goals of generics. The baloxavir marboxil dispute underscores China's transition from a "generics-driven" market to a dual emphasis on innovation and generics, though institutional frameworks must evolve to balance diverse interests. For example, the public health importance of antiviral drugs like baloxavir calls for high accessibility, while the high R&D investments of innovators demand adequate returns. A future "tiered protection" mechanism may be necessary—extending exclusivity for life-saving or rare disease treatments while easing restrictions for common disease therapies to achieve precision policymaking. The global impact of this case should not be overlooked. As Roche’s first major patent litigation in China, the outcome will shape multinational companies' confidence in investing and operating within the Chinese market. If Chinese courts validate the strength of originator patents and uphold enforcement, it could attract more global innovators to prioritize China in their patent strategies. Conversely, a defeat for Roche could prompt companies to reconsider their R&D investment in China, favoring markets with stronger IP protections. Meanwhile, if CSPC’s patent challenge strategy proves successful, it may inspire generics companies in emerging markets like India and Brazil to adopt similar approaches, reshaping global generic drug competition. At this critical juncture, this patent dispute has transcended the boundaries of an individual case, becoming a lens through which to observe the evolution of China’s pharmaceutical industry. It highlights the imperfections in the practical operation of the patent linkage system, tests the judiciary’s ability to adjudicate complex technical disputes, and reflects the perpetual tug-of-war between innovation protection and public health. No matter who ultimately prevails, the case is certain to push China’s pharmaceutical sector toward a more mature competitive ecosystem—where originator companies must reinforce their patent portfolios, generics firms must adopt more prudent challenge strategies, and policymakers must navigate the dynamic balance between encouraging innovation and ensuring accessibility. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

100 Deals associated with Baloxavir Marboxil

External Link

KEGG	Wiki	ATC	Drug Bank
D11021	Baloxavir Marboxil	J05AX25	DB13997

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Influenza, Human	United States	Genentech, Inc.	24 Oct 2018
Influenza A virus infection	Japan	Shionogi & Co., Ltd.	23 Feb 2018
Influenza B virus infection	Japan	Shionogi & Co., Ltd.	23 Feb 2018

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza-like symptoms	Phase 3	United States	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Costa Rica	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Israel	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Mexico	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Poland	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Russia	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Spain	Hoffmann-La Roche, Inc.	20 Nov 2018
Allergic asthma	Preclinical	China	China Pharmaceutical University	10 Feb 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03969212 (CENTERSTONE, CTgov)	Phase 3	Influenza A virus infection	4,138	placebo (Placebo: HHCs)	skjhuyrmhc = qcxldpznsi dbjxwckmho (knykitaraf, qrqplviqhw - uqsylgcqkc) View more	-	24 Apr 2025
				Baloxavir Marboxil (Baloxavir Marboxil: HHCs)	skjhuyrmhc = ktjtuxyvjg dbjxwckmho (knykitaraf, qrwvyepddi - fmncrbtqvn) View more
NCT05170009 (CTgov)	Phase 2/3	Influenza, Human	2	Oseltamivir+Baloxavir Marboxil (Active and Standard of Care)	pcmaiuhcor(ambwxmdxlf) = xgjomspmfy lugxzsvhmz (afdacfrcrl, gbsdcgaasr - cwvusrvqux) View more	-	26 Feb 2025
				Placebo+Oseltamivir (Placebo and Standard of Care)	xdefxwfhme = cgxrgivcqp hnwmvkjeuw (fwcsovdzrf, wzjkayrgda - mzahxkpmdf) View more
NCT03969212 (CENTERSTONE, PipelineReview) Manual	Phase 3	Influenza, Human	-	Xofluza	uatpzmjunr(laspciomry) = demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. bvdcumogmn (kvhpqcvlug ) Met View more	Positive	19 Sep 2024
NCT03653364 (CTgov)	Phase 3	Influenza-like symptoms \| Influenza, Human	49	Baloxavir Marboxil	ovrrilzfzz = qjhxqxnxuk pmrxheyhzs (higchfliht, vxtimswlot - jefwmxogxh) View more	-	17 May 2024
ATS2022	Not Applicable	Influenza A virus infection \| Chronic lung disease	-	Baloxavir Marboxil (BXM)	emlgeghdus(nvtxvegzwm) = omzhoprvsf ucjcwroxnt (idjdbrgsbd ) View more	-	15 May 2022
				Oseltamivir (OSL)	emlgeghdus(nvtxvegzwm) = ucjfzunfgp ucjcwroxnt (idjdbrgsbd ) View more
NCT03959332 (Pubmed \| Clin Transl Sci)	Phase 1	Influenza, Human	32	Baloxavir marboxil 40 mg	cndxjtkxqn(oovtbghubr) = avujecispn ommrlcwyez (qfbeiufmjp ) View more	Positive	17 Feb 2022
				Baloxavir marboxil 80 mg	cndxjtkxqn(oovtbghubr) = fltptwfcbw ommrlcwyez (qfbeiufmjp ) View more
NCT03684044 (Pubmed \| Lancet Infect Dis) Manual	Phase 3	Influenza, Human	366	Neuraminidase inhibitors+Baloxavir Marboxil	nxciaqkhii(nofsnhvofk) = ptgptnftiy abkmlkdeyx (ocaxbwjehr, 75.9 - 117.2) View more	Negative	24 Jan 2022
				Neuraminidase inhibitors +Placebo	nxciaqkhii(nofsnhvofk) = uijgmgsasj abkmlkdeyx (ocaxbwjehr, 75.9 - 144.4) View more
NCT04141930 (pCHIMES, CTgov)	Phase 4	Respirovirus Infections \| Influenza, Human	481	Baloxavir Marboxil	vocjedfdza = dhapoqouft cqnyoivxoa (hyageyxivx, ybqwcpjxdg - byjzymaswi) View more	-	05 Aug 2021
NCT03684044 (CTgov)	Phase 3	Influenza, Human	363	Baloxavir Marboxil (Baloxavir Marboxil)	posqgattcv(munvxpxkgp) = yljczgaxqo jgtanizbjn (gjolkhflae, qxnidqprtq - qdycjkmaez) View more	-	30 Nov 2020
				Placebo (Placebo)	posqgattcv(munvxpxkgp) = qjsswzgzdg jgtanizbjn (gjolkhflae, lvgmruvexr - masoinvtwf) View more
NCT03969212 (Pubmed \| Clin Infect Dis)	Phase 3	Influenza, Human	-	Baloxavir marboxil	grsrfhexwn(zwhaczerzl) = eexzyabmmb fzaozgrphh (cdatmupjvx )	-	26 Oct 2020
				Neuraminidase inhibitors	grsrfhexwn(zwhaczerzl) = bflrcyqokp fzaozgrphh (cdatmupjvx )

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