Sunshine Biopharma's Nora Pharma Receives Health Canada Approval for Niopeg(R), a Biosimilar of Neulasta(R)
Sunshine Biopharma's Nora Pharma Receives Health Canada Approval for Niopeg(R), a Biosimilar of Neulasta(R)
NEW YORK, NY / ACCESSWIRE / April 19, 2024 / Sunshine Biopharma Inc. (NASDAQ:SBFM), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals, is happy to announce that its wholly owned generic pharmaceutical subsidiary, Nora Pharma, has received approval for its first Biosimilar product.
紐約州紐約/ACCESSWIRE/2024年4月19日/陽光生物製藥公司（納斯達克股票代碼：SBFM）是一家在包括腫瘤和抗病毒藥物在內的各種治療領域提供和研究救生藥物的製藥公司，很高興地宣佈，其全資仿製藥子公司諾拉制藥已獲得首款生物仿製藥產品的批准。
Nora Pharma has received approval from Health Canada for the commercialization of NIOPEG (a pegylated form of filgrastim) in Canada. The current market size of pegfilgrastim in Canada is approximately $88 million USD.
諾拉制藥已獲得加拿大衛生部的批准，可以在加拿大將NIOPEG（非格司亭的一種聚乙二醇化形式）商業化。pegfilgrastim目前在加拿大的市場規模約爲8,800萬美元。
NIOPEG is a Biosimilar comparable to the reference biologic drug NEULASTA (pegfilgrastim). NIOPEG is a long-acting form of recombinant human granulocyte colony-stimulating factor (r-HuG-CSF), or filgrastim. It is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. NIOPEG is available in a pre-filled syringe of 6 mg/0.6 mL.
NIOPEG是一種生物仿製藥，可與參考生物藥物NEULASTA（pegfilgrastim）相媲美。NIOPEG 是一種長效形式的重組人粒細胞集落刺激因子（r-HUG-CSF）或非格司汀。在接受骨髓抑制性抗腫瘤藥物的非髓系惡性腫瘤患者中，它有望降低感染髮生率，如發熱性中性粒細胞減少所示。NIOPEG 採用 6 mg/0.6 mL 的預充注射器。
"With this product, we demonstrate to the Canadian market our determination to be a leader in the pharmaceutical sector," said Malek Chamoun, president of Nora Pharma. "This is an important milestone for our mission of bringing high quality affordable medicines to patients across Canada," he added.
諾拉制藥總裁馬利克·查蒙說：“通過該產品，我們向加拿大市場展示了我們成爲製藥行業領導者的決心。”他補充說：“這是我們使命的重要里程碑，即爲加拿大各地的患者提供高質量的負擔得起的藥物。”
"NIOPEG is used to help prevent infection in people with non-myeloid cancers who are receiving chemotherapy. An example of a non-myeloid cancer is breast cancer," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "We are committed to bringing continued value to our shareholders, and launching NIOPEG is one of the ways we are doing that as we move closer and closer to profitability," he continued.
“NIOPEG用於幫助預防正在接受化療的非髓系癌患者的感染。非髓系癌的一個例子是乳腺癌。” 陽光生物製藥首席執行官史蒂夫·斯利拉蒂博士說。他繼續說：“我們致力於爲股東帶來持續的價值，隨着我們越來越接近盈利，推出NIOPEG是我們這樣做的方式之一。”
About Sunshine Biopharma Inc.
關於陽光生物製藥公司
Sunshine Biopharma, through its subsidiary Nora Pharma Inc., has 52 generic prescription drugs on the market in Canada. The Company is planning to expand its product offering to a total of 60 generic prescription drugs by the end of 2024. In parallel, Sunshine Biopharma is continuing its proprietary drug development program which is comprised of (i) K1.1 mRNA for liver cancer, and (ii) PLpro protease inhibitor for SARS Coronavirus infections. For more information, please visit: .
陽光生物製藥通過其子公司諾拉制藥公司在加拿大市場上有52種仿製處方藥。該公司計劃到2024年底將其產品供應範圍擴大到總共60種仿製處方藥。同時，陽光生物製藥正在繼續其專有藥物開發計劃，該計劃包括（i）用於肝癌的K1.1 mRNA和（ii）用於SARS冠狀病毒感染的plPro蛋白酶抑制劑。欲了解更多信息，請訪問:.
Safe Harbor Forward-Looking Statements
安全港前瞻性陳述
This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma, Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a
本新聞稿包含前瞻性陳述，這些陳述基於陽光生物製藥公司（“公司”）當前的預期、預測和假設，這些陳述涉及風險和不確定性，可能導致實際結果和結果與預期或預期存在重大差異。這些陳述出現在本新聞稿中，包括所有不是關於公司意圖、信念或當前預期的歷史事實陳述的陳述，包括與公司藥物開發活動、財務業績和未來增長相關的陳述。公司向美國證券交易委員會（SEC）提交的文件和報告中進一步描述了這些風險和不確定性。實際結果和某些事件發生的時間可能與前瞻性陳述中預測或設想的結果存在重大差異，原因是
number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.
公司向美國證券交易委員會提交的文件中不時詳細說明的因素數量。特此提及公司最近向美國證券交易委員會提交的文件中列出的警示聲明和風險因素。
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Registered trademarks are owned by the respective owner(s) of each product
註冊商標歸每種產品的相應所有者所有
For Additional Information:
欲了解更多信息：
Sunshine Biopharma Contact:
Camille Sebaaly, CFO
Direct Line: 332-216-1147
camille.sebaaly@sunshinebiopharma.com
陽光生物製藥聯繫人：
Camille Sebaaly，首席財務官
直撥電話：332-216-1147
camille.sebaaly@sunshinebiopharma.com
SOURCE: Sunshine Biopharma, Inc.
來源：陽光生物製藥公司
譯文內容由第三人軟體翻譯。