{
  "schema_version": "1.0",
  "type": "article",
  "title": "PharmaEssentia Wins Fifth ET Approval While Merck Awaits Phase 3 Data",
  "url": "https://drugnews.com.tw/articles/2026-10-17-pharmaessentia-china-et-approval-race-en.html",
  "markdown_url": "https://drugnews.com.tw/articles/2026-10-17-pharmaessentia-china-et-approval-race-en.md",
  "lang": "en",
  "date": "2026-10-17",
  "publish_at": "2026-10-17T08:00:00+08:00",
  "updated_at": "2026-10-17",
  "category": "商業分析系列",
  "topic": "商業分析系列",
  "tags": [
    "PharmaEssentia",
    "BESREMi",
    "ropeginterferon alfa-2b",
    "essential thrombocythemia",
    "Merck",
    "Incyte",
    "China NMPA"
  ],
  "summary": "China's NMPA approved PharmaEssentia's BESREMi on October 13 for adults with essential thrombocythemia who respond inadequately to hydroxyurea, its fifth ET approval in five months after Taiwan, Macau, Japan and the US. Merck's two bomedemstat Phase 3 trials are due to reach primary completion in 2027, and Incyte's INCA033989 began Phase 3 enrollment in September. Because China's label is second line only, its estimated 400,000 patients shrink to a rough ceiling of 80,000 to 100,000.",
  "key_points": [
    "PharmaEssentia said on October 15, 2026 that China's NMPA approved BESREMi (ropeginterferon alfa-2b) on October 13 for adults with essential thrombocythemia (ET) who had an inadequate response to hydroxyurea; the company cites a market-research estimate of about 400,000 ET patients in China.",
    "BESREMi gained ET approvals in Taiwan (May 12), Macau (import pre-authorization, announced August 2), Japan (announced August 24), the US (August 28, all adults) and China (October 13) in 2026; Merck's bomedemstat lists Phase 3 primary completion in July and September 2027, and Incyte's INCA033989 began Phase 3 enrollment on September 8, 2026.",
    "PharmaEssentia's September 2026 revenue was NT$2.64 billion, up 99.98% year on year and 0.69% month on month; January–September revenue was NT$19.74 billion, up 83.5%, mainly from its US subsidiary."
  ],
  "facts": [
    {
      "claim": "China NMPA approval of BESREMi for adult ET with inadequate response to hydroxyurea",
      "value": "2026-10-13",
      "unit": "approval date",
      "as_of": "2026-10-15",
      "source": "PharmaEssentia filing (MOPS) 2026-10-15",
      "note": "certificate received 2026-10-15"
    },
    {
      "claim": "Estimated ET patients in China (market research)",
      "value": 400000,
      "unit": "patients",
      "as_of": "2026-10-15",
      "source": "PharmaEssentia filing (MOPS) 2026-10-15",
      "note": "estimate"
    },
    {
      "claim": "Estimated ET patients in the US (market research)",
      "value": 170000,
      "unit": "patients",
      "as_of": "2026-08-29",
      "source": "PharmaEssentia filing (MOPS) 2026-08-29",
      "note": "estimate"
    },
    {
      "claim": "ET patients in Taiwan (NHI database study)",
      "value": 4500,
      "unit": "patients",
      "as_of": "2026-08-16",
      "source": "PharmaEssentia filing (MOPS) 2026-08-16",
      "note": "about 20 per 100,000"
    },
    {
      "claim": "US FDA approval of BESREMi for all adults with ET",
      "value": "2026-08-28",
      "unit": "approval date (US time)",
      "as_of": "2026-08-29",
      "source": "PharmaEssentia filing (MOPS) 2026-08-29"
    },
    {
      "claim": "PharmaEssentia September 2026 revenue",
      "value": 2.635,
      "unit": "NT$ billion",
      "as_of": "2026-10-15",
      "source": "TWSE OpenAPI t187ap05_L",
      "note": "+99.98% YoY, +0.69% MoM"
    },
    {
      "claim": "PharmaEssentia January–September 2026 revenue",
      "value": 19.74,
      "unit": "NT$ billion",
      "as_of": "2026-10-15",
      "source": "TWSE OpenAPI t187ap05_L",
      "note": "+83.5% YoY; mainly US subsidiary"
    },
    {
      "claim": "Merck acquisition of Imago BioSciences (bomedemstat)",
      "value": 1.35,
      "unit": "US$ billion",
      "as_of": "2022-11-21",
      "source": "BioPharma Dive 2022-11-21",
      "note": "$36 per share; closed January 2023"
    },
    {
      "claim": "Shorespan-006 (NCT06079879) estimated primary completion",
      "value": "2027-07-14",
      "unit": "date",
      "as_of": "2026-10-16",
      "source": "ClinicalTrials.gov",
      "note": "second line, ~340 patients"
    },
    {
      "claim": "Shorespan-007 (NCT06456346) estimated primary completion",
      "value": "2027-09-28",
      "unit": "date",
      "as_of": "2026-10-16",
      "source": "ClinicalTrials.gov",
      "note": "vs hydroxyurea, ~300 patients"
    },
    {
      "claim": "INCA033989 Phase 1 ET complete hematologic response",
      "value": 70,
      "unit": "%",
      "as_of": "2026-06-13",
      "source": "Incyte EHA 2026 release",
      "note": "80/114, single-arm"
    },
    {
      "claim": "EXCALIBUR-ET2 (NCT07623200) start date",
      "value": "2026-09-08",
      "unit": "date",
      "as_of": "2026-10-16",
      "source": "ClinicalTrials.gov",
      "note": "estimated primary completion 2029-06-15"
    },
    {
      "claim": "SURPASS-ET durable response at months 9 and 12 (BESREMi vs anagrelide)",
      "value": "43 vs 6",
      "unit": "%",
      "as_of": "2026-08-31",
      "source": "BioPharm International 2026-08-31",
      "note": "174 hydroxyurea-resistant/intolerant patients"
    },
    {
      "claim": "Share of hydroxyurea-treated PV/ET patients who become resistant or intolerant",
      "value": "20-25",
      "unit": "%",
      "as_of": "2014",
      "source": "Sever M, et al. Leukemia & Lymphoma 2014",
      "note": "used for China second-line ceiling of 80,000–100,000"
    }
  ],
  "sections": [
    "01 | Five ET Approvals in Five Months",
    "02 | Side by Side: Where ET Treatments Stand",
    "03 | Discounting China's 400,000 Patients Twice",
    "04 | The Numbers to Watch",
    "Conclusion | Five Approvals Buy Time",
    "References"
  ],
  "references": [
    {
      "title": "PharmaEssentia",
      "source": "Material information: BESREMi approved by China's NMPA for adult ET (in Chinese",
      "date": "2026-10-15",
      "url": "https://mops.twse.com.tw/mops/#/web/t05st01"
    },
    {
      "title": "PharmaEssentia",
      "source": "Material information: BESREMi approved by the US FDA for adult ET (in Chinese",
      "date": "2026-08-29",
      "url": "https://mops.twse.com.tw/mops/#/web/t05st01"
    },
    {
      "title": "PharmaEssentia",
      "source": "Material information: application to Taiwan FDA to widen the ET indication; Taiwan approval letter (2026-05-12); Macau (2026-08-02); Japan (2026-08-24); Singapore filing (2026-10-12) (in Chinese",
      "date": "",
      "url": "https://mops.twse.com.tw/mops/#/web/t05st01"
    },
    {
      "title": "Taiwan Stock Exchange OpenAPI",
      "source": "Monthly revenue of listed companies (PharmaEssentia 6446, September 2026",
      "date": "2026-10-15",
      "url": "https://openapi.twse.com.tw/v1/opendata/t187ap05_L"
    },
    {
      "title": "Merck",
      "source": "Merck Announces Phase 3 Trial Initiation for Bomedemstat for the Treatment of Certain Patients With Essential Thrombocythemia",
      "date": "2024-08-27",
      "url": "https://www.merck.com/news/merck-announces-phase-3-trial-initiation-for-bomedemstat-an-investigational-candidate-for-the-treatment-of-certain-patients-with-essential-thrombocythemia/"
    },
    {
      "title": "BioPharma Dive",
      "source": "Merck to acquire Imago BioSciences for $1.35B",
      "date": "2022-11-21",
      "url": "https://www.biopharmadive.com/news/merck-imago-acquire-deal-bone-marrow-cancer/637054/"
    },
    {
      "title": "ClinicalTrials.gov",
      "source": "Shorespan-007 (NCT06456346), Shorespan-006 (NCT06079879), EXCALIBUR-ET2 (NCT07623200",
      "date": "",
      "url": "https://clinicaltrials.gov/study/NCT06456346"
    },
    {
      "title": "Incyte",
      "source": "Incyte Announces New Positive Data at EHA 2026 Showed INCA033989 Achieved Rapid Robust and Sustained Clinical and Molecular Responses and Was Well Tolerated in Patients with Myelofibrosis and Essential Thrombocythemia",
      "date": "2026-06-13",
      "url": "https://investor.incyte.com/news-releases/news-release-details/incyte-announces-new-positive-data-eha-2026-showed-inca033989"
    },
    {
      "title": "BioPharm International",
      "source": "FDA Approves Ropeginterferon Alfa-2b-njft (Besremi) for Essential Thrombocythemia (SURPASS-ET results",
      "date": "2026-08-31",
      "url": "https://www.biopharminternational.com/view/fda-approves-ropeginterferon-alfa-2b-njft-besremi-essential-thrombocythemia"
    },
    {
      "title": "Sever M, Newberry KJ, Verstovsek S",
      "source": "Therapeutic options for patients with polycythemia vera and essential thrombocythemia refractory/resistant to hydroxyurea",
      "date": "",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4835800"
    },
    {
      "title": "Klampfl T, et al.",
      "source": "Somatic Mutations of Calreticulin in Myeloproliferative Neoplasms",
      "date": "",
      "url": "https://doi.org/10.1056/NEJMoa1311347"
    }
  ],
  "images": [
    {
      "alt": "Figure 1 | BESREMi's 2026 ET approvals: Taiwan, Macau, Japan, the US and China within five months",
      "url": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race-en/figure-01.png"
    },
    {
      "alt": "Figure 2 | ET treatment options side by side: two old drugs, PharmaEssentia, Merck and Incyte",
      "url": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race-en/figure-02.png"
    },
    {
      "alt": "Figure 3 | ET patients by market, and China's rough second-line ceiling",
      "url": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race-en/figure-03.png"
    },
    {
      "alt": "Figure 4 | PharmaEssentia 2026 revenue: NT$2.64 billion in September, NT$19.74 billion for January–September",
      "url": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race-en/figure-04.png"
    }
  ],
  "cover_image": "https://drugnews.com.tw/assets/articles/pharmaessentia-china-et-approval-race-en/cover.png",
  "publisher": {
    "name": "Drugnews｜藥時事",
    "url": "https://drugnews.com.tw/",
    "profile": "https://drugnews.com.tw/brand-profile.json"
  },
  "citation": "Drugnews｜藥時事（2026-10-17）。PharmaEssentia Wins Fifth ET Approval While Merck Awaits Phase 3 Data。https://drugnews.com.tw/articles/2026-10-17-pharmaessentia-china-et-approval-race-en.html",
  "disclaimer": "This article is intended for industry research and knowledge sharing only. It does not constitute investment, medical, fundraising, or individual stock advice.",
  "translations": {
    "zh-Hant": "2026-10-17-pharmaessentia-china-et-approval-race.html"
  }
}