復宏漢霖與Getz Pharma就阿達木單抗漢達遠達成商業化授權合作,覆蓋亞非歐11個新興市場國家
2022年2月23日,復宏漢霖(2696.HK)宣布與Getz Pharma (Private) Limited及其聯屬公司Getz Pharma International FZ-LLC(統稱為“Getz Pharma”)訂立許可及供應協議,授予其在巴基斯坦、菲律賓、越南、緬甸、柬埔寨、尼日利亞、肯尼亞、斯里蘭卡、烏克蘭、哈薩克斯坦和烏茲別克斯坦11個國家以及互相商定的任何其他地區針對阿達木單抗漢達遠®的商業化等權益。
漢達遠®是復宏漢霖自主開發的阿達木單抗生物類似藥,也是公司首款治療自身免疫疾病的產品,已于國內獲批用于類風濕關節炎、強直性脊柱炎、銀屑病、葡萄膜炎等自身免疫疾病的治療,國內的商業化銷售由江蘇萬邦負責。阿達木單抗在全球范圍內已獲批十余項適應癥,其顯著療效已得到普遍認可,獲得北美、歐洲多個臨床實踐指南一致推薦,也是全球最為暢銷的藥物之一。

當前新興市場國家生物制劑的普及率較低,如類風濕關節炎藥物仍以傳統改善病情抗風濕藥(DMARDs)作為主要治療手段,治療需求遠未被滿足。此次簽約區域總人口約8.4億,存在較大的阿達木單抗用藥需求。借助Getz Pharma在南亞、東南亞、非洲、獨聯體國家的強大業務網絡,漢達遠®的商業化布局將擴展更多新興市場國家,為這些國家和地區的病患帶來更多可負擔的優質治療選擇,進一步加快公司商業化全球布局。
包括此項合作在內,復宏漢霖已就4款上市產品漢利康®(利妥昔單抗)、漢曲優®(曲妥珠單抗,歐盟商品名:Zercepac®)、漢達遠®(阿達木單抗)、漢貝泰®(貝伐珠單抗)及2款在研產品HLX04-O(重組抗VEGF人源化單克隆抗體注射液)、H藥斯魯利單抗(創新型抗PD-1單抗)同多家知名藥企達成合作,覆蓋全球主流生物藥市場及眾多新興市場國家。未來,復宏漢霖也將繼續秉持“可負擔的創新”這一初心,攜手更多國際合作伙伴,最大化生物類似藥價值的同時,加速多元化創新,開發更多基于臨床和市場需要的創新型產品,為全球病患帶來更多可負擔的優質生物藥。
關于Getz Pharma
Getz Pharma (Private) Limited于1995年成立于巴基斯坦伊斯蘭共和國,主要從事各種藥品的配方開發、生產和銷售。截止目前,Getz Pharma (Private) Limited在南亞、中亞、東南亞、中東和非洲地區超過25個國家開展業務,在全球擁有6000多名員工。
Getz Pharma International FZ-LLC于2006年成立于阿拉伯聯合酋長國,主要從事醫藥產品銷售、營銷、和出口業務,目前業務范圍廣泛分布在中東、非洲、東南亞及獨聯體國家。
關于復宏漢霖
復宏漢霖(2696.HK)是一家國際化的創新生物制藥公司,致力于為全球患者提供可負擔的高品質生物藥,產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域,已在中國上市4款產品,在歐盟上市1款產品,3個上市注冊申請獲得中國藥監局受理。自2010年成立以來,復宏漢霖已建成一體化生物制藥平臺,高效及創新的自主核心能力貫穿研發、生產及商業運營全產業鏈。公司已建立完善高效的全球研發中心,按照國際藥品生產質量管理規范(GMP)標準進行生產和質量管控,位于上海徐匯的生產基地已獲得中國和歐盟GMP認證。
復宏漢霖前瞻性布局了一個多元化、高質量的產品管線,涵蓋20多種創新單克隆抗體,并全面推進基于自有抗PD-1單抗斯魯利單抗的腫瘤免疫聯合療法。繼國內首個生物類似藥漢利康®(利妥昔單抗)、中國首個自主研發的中歐雙批單抗藥物漢曲優®(曲妥珠單抗,歐盟商品名:Zercepac®)、漢達遠®(阿達木單抗)和漢貝泰®(貝伐珠單抗)相繼獲批上市,創新產品斯魯利單抗MSI-H實體瘤的上市注冊申請已納入優先審評審批程序,HLX01利妥昔單抗類風濕關節炎新適應癥、斯魯利單抗鱗狀非小細胞肺癌適應癥的上市注冊申請也正在審評中。公司亦同步就11個產品、9個免疫聯合治療方案在全球范圍內開展20多項臨床試驗,對外授權全面覆蓋歐美主流生物藥市場和眾多新興市場。
Henlius Entered into a Collaboration with Getz Pharma to Commercialise Adalimumab Biosimilar 漢達遠, Covering 11 Emerging Markets in Asia, Africa and Europe?
Shanghai, China, 23rd February, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Company has entered into a licensing and supply agreement with Getz Pharma (Private) Limited and its affiliated company, Getz Pharma International FZ -LLC (together, “Getz Pharma”), pursuant to which, the company agreed to grant a license to Getz Pharma to commercialise adalimumab biosimilar 漢達遠® in Islamic Republic of Pakistan, the Philippines, Vietnam, Cambodia, Myanmar, Nigeria, Kenya, Sri Lanka, Ukraine, Kazakhstan and Uzbekistan, and any other territories to be mutually agreed.
漢達遠® is the company's first self-developed monoclonal antibody in autoimmune treatment. 漢達遠® was approved by the NMPA for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis (Ps) and uveitis (UV). Jiangsu Wanbang is responsible for the commercial sales of 漢達遠® in China. Adalimumab has been approved for over 10 indications worldwide. Due to its significant efficacy, it has been recommended by guidelines for different autoimmune diseases in North America and Europe, and it is also one of the world's best-selling drugs.
?
The penetration rate of biologics in emerging markets is relatively low. For example, DMARDs are still the main treatment for RA, and the treatment needs are far from being met. The total population of the signed region is about 840 million, and there is a large unmet demand for adalimumab. Leveraging Getz Pharma's strong business network in South Asia, Southeast Asia, Africa and the CIS, the commercial layout of 漢達遠® will be expanded to emerging markets, and Henlius will bring more high-quality treatment options to patients in these countries and regions, accelerating Henlius’ global commercialisation and enhance brand awareness in emerging markets.
?
Up to now, 4 marketed products, 漢利康® (rituximab), 漢曲優® (trastuzumab, Zercepac® in EU), 漢達遠® (adalimumab), 漢貝泰® (bevacizumab), and 2 under development products, HLX04-O (recombinant anti-VEGF humanized monoclonal antibody) and Serplulimab (innovative anti-PD-1 monoclonal antibody) have reached cooperation with a number of leading pharmaceutical companies, covering the global major market as well as emerging market. In the future, with the long-term commitment to “affordable innovation”, Henlius will actively collaborate with more global industry leaders, maximizing the value of biosimilars and accelerating diversified innovation to develop more products based on clinical and market needs to deliver more affordable products to patients worldwide.
About Getz Pharma
Getz Pharma (Private) Limited was established in the Islamic Republic of Pakistan in 1995, which mainly specializes in the formulation development, manufacturing and marketing of a wide range of pharmaceutical products. It currently operates in more than 25 countries in South Asia, Central Asia, South East Asia, the Middle East and Africa and has more than 6,000 employees worldwide.
Getz Pharma International FZ-LLC was established in the United Arab Emirates in 2006, which mainly specializes in sales, marketing, export and distribution of a wide range of pharmaceutical products in the Middle East, Africa, Southeast Asia and CIS countries.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 4 products have been launched in China, 1 in the European Union (EU), 3 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centres and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 漢利康® (rituximab), the first China-developed biosimilar, 漢曲優® (trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU, 漢達遠® (adalimumab) and 漢貝泰® (bevacizumab), the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX01 (rituximab) for the treatment of rheumatoid arthritis and serplulimab for the treatment of squamous non-small cell lung cancer are also under review. What's more, Henlius has conducted over 20 clinical studies for 11 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.
聯系方式
媒體:PR@Henlius.com
投資者:IR@Henlius.com
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