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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)

阳光生物制药的诺拉制药获得加拿大卫生部的批准,其生物仿制药Niopeg(R)是Neulasta(R)的生物仿制药
Accesswire ·  04/19 08:00

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.

纽约州纽约/ACCESSWIRE/2024年4月19日/阳光生物制药公司(纳斯达克股票代码:SBFM)是一家在包括肿瘤和抗病毒药物在内的各种治疗领域提供和研究救生药物的制药公司,很高兴地宣布,其全资仿制药子公司诺拉制药已获得首款生物仿制药产品的批准。

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.

诺拉制药已获得加拿大卫生部的批准,可以在加拿大将NIOPEG(非格司亭的一种聚乙二醇化形式)商业化。pegfilgrastim目前在加拿大的市场规模约为8,800万美元。

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是一种生物仿制药,可与参考生物药物NEULASTA(pegfilgrastim)相媲美。NIOPEG 是一种长效形式的重组人粒细胞集落刺激因子(r-HUG-CSF)或非格司汀。在接受骨髓抑制性抗肿瘤药物的非髓系恶性肿瘤患者中,它有望降低感染发生率,如发热性中性粒细胞减少所示。NIOPEG 采用 6 mg/0.6 mL 的预充注射器。

"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.

诺拉制药总裁马利克·查蒙说:“通过该产品,我们向加拿大市场展示了我们成为制药行业领导者的决心。”他补充说:“这是我们使命的重要里程碑,即为加拿大各地的患者提供高质量的负担得起的药物。”

"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用于帮助预防正在接受化疗的非髓系癌患者的感染。非髓系癌的一个例子是乳腺癌。” 阳光生物制药首席执行官史蒂夫·斯利拉蒂博士说。他继续说:“我们致力于为股东带来持续的价值,随着我们越来越接近盈利,推出NIOPEG是我们这样做的方式之一。”

About Sunshine Biopharma Inc.

关于阳光生物制药公司

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: .

阳光生物制药通过其子公司诺拉制药公司在加拿大市场上有52种仿制处方药。该公司计划到2024年底将其产品供应范围扩大到总共60种仿制处方药。同时,阳光生物制药正在继续其专有药物开发计划,该计划包括(i)用于肝癌的K1.1 mRNA和(ii)用于SARS冠状病毒感染的plPro蛋白酶抑制剂。欲了解更多信息,请访问:.

Safe Harbor Forward-Looking Statements

安全港前瞻性陈述

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

本新闻稿包含前瞻性陈述,这些陈述基于阳光生物制药公司(“公司”)当前的预期、预测和假设,这些陈述涉及风险和不确定性,可能导致实际结果和结果与预期或预期存在重大差异。这些陈述出现在本新闻稿中,包括所有不是关于公司意图、信念或当前预期的历史事实陈述的陈述,包括与公司药物开发活动、财务业绩和未来增长相关的陈述。公司向美国证券交易委员会(SEC)提交的文件和报告中进一步描述了这些风险和不确定性。实际结果和某些事件发生的时间可能与前瞻性陈述中预测或设想的结果存在重大差异,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.

公司向美国证券交易委员会提交的文件中不时详细说明的因素数量。特此提及公司最近向美国证券交易委员会提交的文件中列出的警示声明和风险因素。

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Registered trademarks are owned by the respective owner(s) of each product

注册商标归每种产品的相应所有者所有

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

阳光生物制药联系人:
Camille Sebaaly,首席财务官
直拨电话:332-216-1147
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma, Inc.

来源:阳光生物制药公司


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