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    Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world. Intas has set up a network of subsidiaries, under the umbrella name of Accord Healthcare to operate in global markets. Over the years, Intas has grown ...
    Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world. Intas has set up a network of subsidiaries, under the umbrella name of Accord Healthcare to operate in global markets. Over the years, Intas has grown both organically and via acquisition, expanding its product portfolio and operations year on year.

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    Intas Pharmaceuticalsindia-flag Flag
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    India
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    Chinubhai Centre, Off. Nehru Bridge, Ashram Road, Ahmedabad, Gujarat
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    +91 79 6652 3100
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    This week, SpeakPharma interviews Miquel Bachs, CEO of Inke, a company with over two decades of expertise in micronization and particle engineering, and a leader in providing high-quality, effective solutions in the global fight against chronic respiratory diseases such as COPD and asthma. In this insightful conversation, Bachs shares Inke’s strategic vision, technological innovations, and commitment to sustainability, offering a comprehensive look at how the company is shaping the future of respiratory health. HIGHLIGHTS// Inke’s strategic vision/ technological innovations/ commitment to sustainability Studies suggest that 13 percent of people over 40 years of age, the world over, have chronic obstructive pulmonary disease (COPD). Given the increasing prevalence of respiratory diseases, how does Inke position itself as a leader in the development and manufacturing of respiratory APIs? Inke has established itself as a global leader in generic respiratory API development through our unique blend  of technological innovation, expertise in micronization, and a comprehensive portfolio of inhalation therapies. With over 20 years of experience in micronization and particle engineering, our ability to customize APIs to meet specific client requirements has resulted in highly effective, high-quality products tailored for respiratory therapies. The increasing prevalence of chronic respiratory diseases, such as COPD and asthma, has only underscored Inke’s pivotal role in supporting the pharmaceutical industry’s need for advanced treatments. We specialize in bronchodilators and other critical respiratory APIs that improve patient outcomes and meet the stringent regulatory requirements of global health authorities. Our end-to-end approach, from early-stage API development to commercial-scale production, ensures that we maintain the highest standards of quality, safety, and efficacy. As the market for respiratory APIs continues to evolve, Inke remains committed to expanding its portfolio to address unmet therapeutic needs. Beyond respiratory APIs, we are also prioritizing growth in CNS treatments and building on our expertise in complex molecule synthesis. This strategic focus allows us to provide an integrated solution that not only meets current market demands but also anticipates future pharmaceutical trends. HIGHLIGHTS// comprehensive portfolio of inhalation therapies/ over 20 years of experience in micronization and particle engineering/ specialize in bronchodilators and other critical respiratory APIs/ prioritizing growth in CNS treatments In the field of micronization, what differentiates Inke’s approach from that of other manufacturers of respiratory APIs? What sets Inke apart in micronization is our advanced particle size reduction technology and our dedication to precision. Our facility is equipped with various milling techniques such as Cone, Jet, and Pin mills, allowing us to reduce particle size while stabilizing the amorphous content to ensure consistent quality. Our in-depth understanding of respiratory APIs, combined with our ability to tailor solutions for each customer, results in APIs with improved solubility, stability, and bioavailability, which are critical for the efficacy of inhalation products. This, along with our exceptional quality standards and a flawless audit track record, has positioned us as a key partner for major players in the inhalation market. HIGHLIGHTS// advanced particle size reduction technology/ technological innovations/ tailor solutions/ improved solubility, stability, and bioavailability Developing complex APIs can be challenging. How does Inke ensure a smooth and successful partnership throughout the development and manufacturing process, including customization, ensuring regulatory compliance and timely delivery? At Inke, we are dedicated to fostering strong partnerships with our clients through a collaborative approach that prioritizes open communication and mutual understanding. Our commitment to quality and personalized service sets us apart in the pharmaceutical landscape. Our team takes the time to engage in comprehensive discussions to customize our solutions, ensuring alignment with client specifications across all batches and grades. This commitment to flexibility allows us to respond effectively to evolving requirements, solidifying Inke’s reputation as a reliable partner. We understand that navigating regulatory landscapes can be challenging. That's why our team is equipped to manage all aspects of the regulatory process with meticulous attention to detail. From the submission of Drug Master Files (DMFs) and Certificates of Suitability to crafting precise responses to potential Deficiency Letters, we ensure compliance at every step. Moreover, we offer extensive support in patent and intellectual property matters, providing technical assistance and guidance tailored to the specific requirements of each region. Our unwavering dedication to quality, coupled with our agile response capabilities, enables us to deliver exceptional results while maintaining transparency and trust. At Inke, we are committed to building lasting relationships that drive success for both our clients and our organization. HIGHLIGHTS// ensuring alignment with client specifications/ manage all aspects of the regulatory process/ support in patent and intellectual property matters Given Inke’s global presence, what are the key markets for growth and how does Inke plan to expand its market reach and strengthen its position in these regions? Inke is strategically focused on expanding its footprint in the European and US markets, where we continue to prioritize our efforts. The US market remains pivotal for us, especially considering our successful FDA inspections and ongoing regulatory compliance efforts that solidify our reputation. Japan is another significant market where we have established a robust presence, reflecting our commitment to high-quality manufacturing and innovation. Looking ahead, China represents a key growth opportunity for Inke. With 12 active DMFs registered, we are well-positioned to tap into this burgeoning market. Our strategy involves leveraging our existing capabilities to navigate regulatory landscapes and fostering strong partnerships within the region, thereby enhancing our market reach and influence in the pharmaceutical sector. HIGHLIGHTS// expanding footprint in the European and US markets/ China represents a key growth opportunity for Inke With Inke expanding into contract manufacturing organization (CMO) services, how does this new offering align with Inke’s broader strategic goals, and what advantages does it provide to pharmaceutical partners? At Inke, the introduction of CMO services is a natural extension of our core expertise in the development and manufacturing of high-quality generic APIs. Our expansion into CMO is part of a strategic move to diversify our service portfolio, allowing us to offer end-to-end solutions for our clients. The CMO service integrates seamlessly with our expertise in API manufacturing, particularly in micronization, which has been a key differentiator for Inke for over two decades. With our advanced particle engineering capabilities, we can offer tailored solutions that meet specific technical and regulatory requirements. Whether it is small-batch production or scaling up to commercial quantities, we offer the flexibility to accommodate a wide range of customer needs. This adaptability, paired with our deep expertise in micronization, allows us to support evolving project needs, maintaining the highest standards of consistency, quality, and performance that define Inke’s footprint. HIGHLIGHTS// CMO is part of a strategic move to diversify our service portfolio/ deep expertise in micronization What is Inke’s commitment to sustainability and corporate social responsibility and how is it integrating sustainable practices into its operations and product development? At Inke, we recognize that integrating environmental, social, and governance (ESG) principles into our operations is not just a responsibility but a pathway to long-term success. Our ESG vision is centered around aligning business growth with sustainable practices that positively impact our communities and the environment. We are dedicated to environmental responsibility, actively implementing initiatives such as efficient wastewater treatment and water reuse systems to minimize our ecological footprint. Our recent investments in energy efficiency include the installation of a 135 kWp solar panel system, which underscores our commitment to reducing emissions and resource consumption across our manufacturing and research facilities. Inke is also committed to fostering a diverse and inclusive workforce. With a notable increase in our team members, particularly in operations and quality assurance, we prioritize career development and the well-being of our employees. By adhering to high regulatory standards, we ensure our products meet stringent global requirements, enhancing our transparency and compliance. Through these initiatives, Inke aims to cultivate sustainable practices that not only support our business objectives but also contribute positively to the pharmaceutical industry and society at large. HIGHLIGHTS// integrating ESG principles/ efficient wastewater treatment and water reuse systems/ installation of a 135 kWp solar panel system/ diverse and inclusive workforce

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    https://www.pharmacompass.com/speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases

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    28 Oct 2024
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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

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    24 Oct 2024
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    Enforcement Report - Week of October 23, 2024
    Enforcement Report - Week of October 23, 2024

    23 Oct 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-23-2024-21885.pdf

    FDA
    23 Oct 2024
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    Accord Healthcare Receives Positive CHMP Opinion for Imuldosa
    Accord Healthcare Receives Positive CHMP Opinion for Imuldosa

    19 Oct 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/accord-healthcare-receives-positive-chmp-opinion-for-imuldosa-a-ustekinumab-biosimilar-to-stelara-302280374.html

    PR NEWSWIRE
    19 Oct 2024
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    Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY
    Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY

    21 Sep 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/henlius-and-intas-receive-positive-chmp-opinion-for-hetronifly-approved-as-hansizhuang-in-china-in-european-markets-as-first-line-treatment-for-adult-patients-with-extensive-stage-small-cell-lung-cancer-302254345.html

    PR NEWSWIRE
    21 Sep 2024
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    Accord BioPharma’s HERCESSI secures FDA approval
    Accord BioPharma’s HERCESSI secures FDA approval

    30 Apr 2024

    // PHARMACEUTICAL TECHNOLOGY

    https://www.pharmaceutical-technology.com/news/accord-biopharma-hercessi-fda/

    PHARMACEUTICAL TECHNOLOGY
    30 Apr 2024
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    Intas Pharmaceuticals is on FDA Import Alert List
    Intas Pharmaceuticals is on FDA Import Alert List

    10 Apr 2024

    // FDA

    https://www.accessdata.fda.gov/cms_ia/importalert_189.html

    FDA
    10 Apr 2024
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    Intas inks agreement for treating autoimmune diseases in 150+ countries
    Intas inks agreement for treating autoimmune diseases in 150+ countries

    20 Dec 2023

    // BIOSPECTRUM ASIA

    https://www.biospectrumasia.com/news/25/23499/indian-firm-intas-pharma-inks-new-licensing-agreement-for-treating-autoimmune-diseases-in-150-countries.html

    BIOSPECTRUM ASIA
    20 Dec 2023
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    Doxorubicin Hydrochloride

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    Docetaxel

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    Intas Pharmaceuticals

    Registrant Name : Myungmoon Pharmaceutical Co., Ltd.

    Registration Date : 2021-01-13

    Registration Number : 20210113-210-J-821

    Manufacturer Name : Intas Pharmaceuticals Limited

    Manufacturer Address : Plot No. 457 & 458, Village Matoda, Bavla road and Plot No. 191/218 P, Village Chacha...

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    Doxorubicin hydrochloride

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    Intas Pharmaceuticals

    Registrant Name : Sampoong Pharmachem Co., Ltd.

    Registration Date : 2020-11-16

    Registration Number : 20201116-210-J-443

    Manufacturer Name : Intas pharmaceutical limited

    Manufacturer Address : 2702/A, GIDC Estate, Ankleshwar-393 002, Dist: Bharuch, Gujarat,India

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    Doxorubicin hydrochloride

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    Intas Pharmaceuticals

    Registrant Name : Ildong Pharmaceutical Co., Ltd.

    Registration Date : 2021-04-22

    Registration Number : 20201116-210-J-443(3)

    Manufacturer Name : Intas pharmaceutical limited

    Manufacturer Address : 2702/A, GIDC Estate, Ankleshwar-393 002, Dist: Bharuch, Gujarat, India

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    Doxorubicin hydrochloride

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    Intas Pharmaceuticals

    Registrant Name : Boryeong Co., Ltd.

    Registration Date : 2021-01-28

    Registration Number : 20201116-210-J-443(1)

    Manufacturer Name : Intas Pharmaceuticals Limited

    Manufacturer Address : 2702/A, GIDC Estate, Ankleshwar- 393 002, Dist: Bharuch, Gujarat, India

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    Doxorubicin hydrochloride

    India
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    Intas Pharmaceuticals

    Registrant Name : Korea United Pharmaceutical Co., Ltd.

    Registration Date : 2021-01-28

    Registration Number : 20201116-210-J-443(2)

    Manufacturer Name : Intas Pharmaceuticals Limited

    Manufacturer Address : 2702/A, GIDC Estate, Ankleshwar -393 002, Bharuch, Gujarat, India

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    Epirubicin hydrochloride

    India
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    Epirubicin hydrochloride

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    Intas Pharmaceuticals

    Registrant Name : Sampoong Pharmachem Co., Ltd.

    Registration Date : 2015-01-20

    Registration Number : 20150120-157-I-425-05

    Manufacturer Name : INTAS Pharmaceuticals Limited

    Manufacturer Address : 2702/A, GIDC Estate, Ankleshwar -393 002, Bharuch, India

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    Epirubicin hydrochloride

    India
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    Epirubicin hydrochloride

    India
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    Intas Pharmaceuticals

    Registrant Name : Boryeong Co., Ltd.

    Registration Date : 2018-05-29

    Registration Number : 20150120-157-I-425-05(1)

    Manufacturer Name : INTAS Pharmaceuticals Limited

    Manufacturer Address : 2702/A, GIDC Estate, Ankleshwar -393 002, Bharuch, India

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    Epirubicin hydrochloride

    India
    World Vaccine Congress
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    India
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    Intas Pharmaceuticals

    Registrant Name : Korea United Pharmaceutical Co., Ltd.

    Registration Date : 2021-03-10

    Registration Number : 20150120-157-I-425-05(2)

    Manufacturer Name : INTAS Pharmaceuticals Limited

    Manufacturer Address : 2702/A, GIDC Estate, Ankleshwar -393 002, Bharuch, India

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    Imatinib mesylate

    India
    World Vaccine Congress
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    India
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    Intas Pharmaceuticals

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2022-04-08

    Registration Number : 207-54-ND

    Manufacturer Name : Intas Pharmaceuticals Limited

    Manufacturer Address : Plot No. 457 & 458, Village Matoda, Bavla road and Plot No. 191/218 P, Village Chacha...

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    Sodium methoxide solution

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    Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world. Intas has set up a network of subsidiaries, under the umbrella name of ...
    Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world. Intas has set up a network of subsidiaries, under the umbrella name of Accord Healthcare to operate in global markets. Over the years, Intas has grown both organically and via acquisition, expanding its product portfolio and operations year on year.
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    Sodium methoxide solution

    India
    SupplySide West 2024
    Not Confirmed
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    Sodium methoxide solution

    India
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    SupplySide West 2024
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    Intas Pharmaceuticals

    Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world. Intas has set up a network of subsidiaries, under the umbrella name of Accord Healthcare to operate in global markets. Over the years, Intas has grown both organically and via acquisition, expanding its product portfolio and operations year on year.

    About the Company : Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal ne...

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    Drugs in Development

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    Accord Gets Positive CHMP Opinion for Stelara® Biosimilar IMULDOSA®

    Details:

    Imuldosa (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. It is indicated for the treatment of moderate to severe plague psoriasis.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Imuldosa

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 19, 2024

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    Accord healthcare

    United Kingdom
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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Accord Gets Positive CHMP Opinion for Stelara® Biosimilar IMULDOSA®

    Details : Imuldosa (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. It is indicated for the treatment of moderate to severe plague psoriasis.

    Brand Name : Imuldosa

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    October 19, 2024

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    Henlius, Intas Get CHMP Nod for HETRONIFLY® in Small Cell Lung Cancer

    Details:

    Hetronifly (serplulimab) is a PD-1 inhibitor antibody, which is currently being evaluated for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer.


    Lead Product(s): Serplulimab

    Therapeutic Area: Oncology Brand Name: Hetronifly

    Study Phase: Phase IIIProduct Type: Large molecule

    Recipient: Henlius

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 21, 2024

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    Intas Pharmaceuticals

    India
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    Intas Pharmaceuticals

    India
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    Lead Product(s) : Serplulimab

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Recipient : Henlius

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Henlius, Intas Get CHMP Nod for HETRONIFLY® in Small Cell Lung Cancer

    Details : Hetronifly (serplulimab) is a PD-1 inhibitor antibody, which is currently being evaluated for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer.

    Brand Name : Hetronifly

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 21, 2024

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    FDA Accepts BLA for Dong-A ST's DMB-3115, a Proposed Biosimilar to Stelara

    Details:

    DMB-3115 (ustekinumab-biosimilar) is an IL-12/23 inhibitor which is being evaluated in phase 3 clinical trials for the treatment of patients with moderate-to-severe chronic plaque psoriasis.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: DMB-3115

    Study Phase: Phase IIIProduct Type: Large molecule

    Recipient: Accord BioPharma

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 05, 2024

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    Intas Pharmaceuticals

    India
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    India
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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Recipient : Accord BioPharma

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Accepts BLA for Dong-A ST's DMB-3115, a Proposed Biosimilar to Stelara

    Details : DMB-3115 (ustekinumab-biosimilar) is an IL-12/23 inhibitor which is being evaluated in phase 3 clinical trials for the treatment of patients with moderate-to-severe chronic plaque psoriasis.

    Brand Name : DMB-3115

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    January 05, 2024

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    Indian firm Intas Pharma Inks New Licensing Agreement for Treating Autoimmune Diseases in 150+ Countries

    Details:

    Under the agreement, Intas receives exclusive rights to commercialise Etanercept biosimilars, through its affiliates, for the treatment of various autoimmune diseases, in more than 150 countries across the globe, including Europe and the United States of America.


    Lead Product(s): Etanercept

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Large molecule

    Recipient: Mabxience

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement December 20, 2023

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    Intas Pharmaceuticals

    India
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    Lead Product(s) : Etanercept

    Therapeutic Area : Immunology

    Highest Development Status : Undisclosed

    Recipient : Mabxience

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Indian firm Intas Pharma Inks New Licensing Agreement for Treating Autoimmune Diseases in 150+ Cou...

    Details : Under the agreement, Intas receives exclusive rights to commercialise Etanercept biosimilars, through its affiliates, for the treatment of various autoimmune diseases, in more than 150 countries across the globe, including Europe and the United States of...

    Brand Name : Undisclosed

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    December 20, 2023

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    Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission

    Details:

    Tecfidera-Generic (dimethyl fumarate) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with relapsing forms of multiple sclerosis.


    Lead Product(s): Dimethyl Fumarate

    Therapeutic Area: Neurology Brand Name: Tecfidera-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 19, 2023

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    Accord healthcare

    United Kingdom
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    Accord healthcare

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    Lead Product(s) : Dimethyl Fumarate

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the Europea...

    Details : Tecfidera-Generic (dimethyl fumarate) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with relapsing forms of multiple sclerosis.

    Brand Name : Tecfidera-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 19, 2023

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    Henlius Deepens Collaboration with Intas to Bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India

    Details:

    Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch of specific formulation of HANSIZHUANG (serplulimab injection), Henlius' novel anti-PD-1 mAb.


    Lead Product(s): Serplulimab,Fluorouracil

    Therapeutic Area: Oncology Brand Name: Hansizhuang

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Henlius

    Deal Size: $195.5 million Upfront Cash: $44.4 million

    Deal Type: Collaboration October 27, 2023

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    Intas Pharmaceuticals

    India
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    Intas Pharmaceuticals

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    Lead Product(s) : Serplulimab,Fluorouracil

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Recipient : Henlius

    Deal Size : $195.5 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Henlius Deepens Collaboration with Intas to Bring Henlius' Novel anti-PD-1 mAb Serplulimab to Euro...

    Details : Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch of specific formulation of HANSIZHUANG (serplulimab injection), Henlius' novel anti-PD-1 mAb.

    Brand Name : Hansizhuang

    Molecule Type : Large molecule

    Upfront Cash : $44.4 million

    October 27, 2023

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    ACCORD and HIPRA Enter into Exclusive Distribution Agreement to Commercialise HIPRA's COVID-19 vaccine (BIMERVAX®) in the United Kingdom

    Details:

    The agreement aims for the commercialisation of HIPRA's mRNA COVID-19 vaccine, Bimervax, which combines a part of the SARS-CoV-2 virus spike protein with an adjuvant, in the United Kingdom.


    Lead Product(s): Recombinant, Adjuvanted Covid-19 Vaccine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Bimervax

    Study Phase: ApprovedProduct Type: Vaccine

    Sponsor: Laboratorios HIPRA

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement August 04, 2023

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    Accord healthcare

    United Kingdom
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    Accord healthcare

    United Kingdom
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    Lead Product(s) : Recombinant, Adjuvanted Covid-19 Vaccine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Laboratorios HIPRA

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    ACCORD and HIPRA Enter into Exclusive Distribution Agreement to Commercialise HIPRA's COVID-19 vac...

    Details : The agreement aims for the commercialisation of HIPRA's mRNA COVID-19 vaccine, Bimervax, which combines a part of the SARS-CoV-2 virus spike protein with an adjuvant, in the United Kingdom.

    Brand Name : Bimervax

    Molecule Type : Vaccine

    Upfront Cash : Undisclosed

    August 04, 2023

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    Accord Healthcare Adds Generic Drug Approved for the Treatment of Relapsing MS

    Details:

    Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. It is indicated for the treatment of relapsing forms of multiple sclerosis.


    Lead Product(s): Teriflunomide

    Therapeutic Area: Neurology Brand Name: Aubagio-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 13, 2023

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    Accord healthcare

    United Kingdom
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    Accord healthcare

    United Kingdom
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    Lead Product(s) : Teriflunomide

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Accord Healthcare Adds Generic Drug Approved for the Treatment of Relapsing MS

    Details : Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. It is indicated for the treatment of relapsing forms of multiple sclerosis...

    Brand Name : Aubagio-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 13, 2023

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    Accord Healthcare Offers Generic Option for Treatment of Schizophrenia and Bipolar Depression

    Details:

    Lurasidone hydrochloride is a, oral atypical antipsychotic, full antagonist at dopamine D2 and serotonin 5-HT2A and 5-HT7 receptors, it is a first-line treatment option for the management of schizophrenia in adults and adolescents.


    Lead Product(s): Lurasidone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Lurasidone-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 21, 2023

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    Accord healthcare

    United Kingdom
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    Accord healthcare

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    Lead Product(s) : Lurasidone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Accord Healthcare Offers Generic Option for Treatment of Schizophrenia and Bipolar Depression

    Details : Lurasidone hydrochloride is a, oral atypical antipsychotic, full antagonist at dopamine D2 and serotonin 5-HT2A and 5-HT7 receptors, it is a first-line treatment option for the management of schizophrenia in adults and adolescents.

    Brand Name : Lurasidone-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 21, 2023

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    EMA Recommends Granting a Marketing Authorisation for Plerixafor Accord

    Details:

    Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.


    Lead Product(s): Plerixafor

    Therapeutic Area: Oncology Brand Name: Mozobil-Generic

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 10, 2022

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    Accord healthcare

    United Kingdom
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    Accord healthcare

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    Lead Product(s) : Plerixafor

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    EMA Recommends Granting a Marketing Authorisation for Plerixafor Accord

    Details : Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.

    Brand Name : Mozobil-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 10, 2022

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