卢旺达推进本土高端生物药生产 Bio Usawa 单克隆抗体工厂预计今年第四季度在 Kigali 启用
据 Business Tech Africa 10月17日报道，总部位于 Kigali 的生物技术公司 Bio Usawa 正在推进其单克隆抗体生产设施的建设，预计于2026年第四季度启用。该公司称，这将是撒哈拉以南非洲第一座单克隆抗体生产工厂。
单克隆抗体是一类生物药，用于治疗部分癌症、眼病和自身免疫性疾病，其生产需要专门的设备、受控的生产环境和能够处理活细胞的专业人员。这类药物此前大多在非洲以外地区生产，非洲患者获取时常面临供应不稳与价格高昂的问题。
Bio Usawa 的眼科产品 BioUcenta 已于2025年10月获得卢旺达食品药品管理局批准。该产品是雷珠单抗的生物类似药，用于治疗糖尿病黄斑水肿、年龄相关性黄斑变性等眼病。卢旺达食品药品管理局是获世界卫生组织评定为监管成熟度三级（ML3）的监管机构。公司此前表示，该产品的定价可比原研药 Lucentis 低最多80%。
2026年9月14日，Bio Usawa 与药品采购平台 Axmed 宣布达成战略合作，把该公司在生物药研发与生产上的能力与 Axmed 面向中低收入国家的药品采购平台对接，首批合作聚焦眼科与视网膜疾病。Bio Usawa 首席运营官 Dr. Patrick Lukulay 表示：「生产只是可及性方程式的一部分。我们需要确保在非洲生产的药物，能够高效地通过服务非洲患者的卫生系统流通。」
Bio Usawa 由 Dr. Menghis Bairu 与 Richard Chin 创立。公司今年1月曾发布征求合作伙伴的公告，寻求在冷链物流、仓储、海关清关、产品注册与医院配送等环节与非洲企业合作。工厂的完整产能与就业数字，公司尚未公开确认。（GSM 据 Business Tech Africa、GlobeNewswire 公开报道）
Bio Usawa's Kigali Plant Aims to Bring Monoclonal Antibody Production to Rwanda in Late 2026
Kigali-headquartered biotechnology company Bio Usawa is pressing ahead with its monoclonal antibody manufacturing facility, which is expected to launch in the fourth quarter of 2026, Business Tech Africa reported on October 17. The company says the plant will be the first monoclonal antibody manufacturing facility in Sub-Saharan Africa.
Monoclonal antibodies are biologic medicines used to treat certain cancers, eye diseases and autoimmune conditions. Their production requires specialised equipment, controlled environments and people trained to work with living cells. Such medicines have largely been produced outside Africa, and patients on the continent have often faced erratic supplies and high prices.
Bio Usawa's ophthalmology product BioUcenta was approved by the Rwanda Food and Drugs Authority in October 2025. It is a biosimilar of ranibizumab, used to treat eye conditions including diabetic macular edema and age-related macular degeneration. The Rwanda FDA is recognised by the World Health Organization as a Maturity Level 3 regulatory authority. The company has previously said the therapy is expected to be priced as much as 80 percent below Lucentis.
On September 14, 2026, Bio Usawa and medicines procurement platform Axmed announced a strategic collaboration linking Bio Usawa's biologics development and manufacturing capability with Axmed's procurement marketplace for low- and middle-income countries, initially focusing on ophthalmology and retinal diseases. 'Manufacturing is only one part of the access equation,' said Dr. Patrick Lukulay, Chief Operating Officer of Bio Usawa. 'We need to make sure that medicines made in Africa can move efficiently through the health systems that serve African patients.'
Bio Usawa was founded by Dr. Menghis Bairu and Richard Chin. In January 2026 the company published a request for proposals seeking African partners for cold-chain logistics, warehousing, customs clearance, product registration and distribution to hospitals. The plant's full production capacity and job numbers have not been publicly confirmed by the company. (GSM, based on reporting by Business Tech Africa and GlobeNewswire releases)
来源：GSM·美国（原文链接）
图片来源：Kigali 城市远眺。View over Kigali. Photo by Honeybarger, Wikimedia Commons, CC BY-SA 4.0.
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