Source: Wabei network https://mp.weixin.qq.com/s/A_j-ngDIsRzRYKASUv93wA

        The intelligent bioengineering drug production base of NORTHLAND, an innovative pharmaceutical company listed on the Select Tier—Beijing Northland Biotechnology Co., Ltd. (stock abbreviation: NORTHLAND, stock code: 430047)—has officially broken ground in the Zhongguancun Tongzhou Park. This marks the official start of construction of China's first production facility for naked plasmid gene therapy drugs.

        The key to innovative biopharmaceuticals lies in R&D, a principle that NORTHLAND, which has been dedicated to this field for 17 years, understands deeply. As an important link in the industrialization of NORTHLAND’s new drugs, the newly inaugurated intelligent bioengineering drug production base will undertake the R&D, translation, production, and commercialization of the company’s core drugs, including recombinant human hepatocyte growth factor naked plasmid injection (code-named NL003) and injectable recombinant human thymosin β4 (code-named NL005). This marks a new milestone in the company’s journey toward commercializing its new drugs.

China’s first production facility for naked plasmid gene therapy drugs officially breaks ground.

        October 22, 2021 The groundbreaking ceremony for the NORTHLAND Intelligent Bioengineering Pharmaceutical Production Base was held in Zhongguancun Tongzhou Park.

        It is understood that the production base project, which has now commenced construction, has a total investment of approximately 450 million RMB. The site covers an area of 36,000 square meters, with a total floor area of about 45,000 square meters. The project will include a research and development center, a workshop for the production of self-developed pharmaceutical products, a CMO production workshop, and warehouses for raw materials and excipients.

        In the early planning stages, the in-house pharmaceutical workshop was equipped with two bulk drug substance production lines for biologics and one formulation and packaging production line. These facilities will initially be used to manufacture two Class 1 biological new drugs—NL003 and NL005—that have been independently developed. The annual production capacities of these two products will be 1 million vials and 5 million vials, respectively, with an annual output value reaching up to 5.3 billion yuan. Upon completion and commissioning of this facility, it will become China’s first production base dedicated to naked plasmid-based gene therapy drugs.

         According to the introduction, this project has incorporated the concepts of smart factories and intelligent industrial parks from the conceptual design stage. It has set goals aimed at achieving automation, continuous operation, digitalization, and intelligence in both production and operational management. The project strives to build a modern, high-end, intelligent biopharmaceutical manufacturing base that is low-carbon, energy-efficient, and environmentally friendly. By leveraging digital and intelligent technologies, it will ensure autonomous control over the entire product lifecycle, further strengthening the company’s technological capabilities.

Actively promote the commercialization process of new drugs.

        For a company like NORTHLAND, which specializes in the R&D of bioengineering drugs, the commencement of construction of an intelligent bioengineering drug production base marks an important milestone in the company's transition toward industrialization. This base will initially take on the production and commercialization of the company’s core products—such as the independently developed bioengineering drugs NL003 and NL005.

        It is understood that NL003 is a naked plasmid gene therapy product primarily developed for the treatment of severe lower-limb ischemia (Critical Limb Ischemia, CLI), including patients suffering from rest pain and ulcers. It may also be further developed for the indication of intermittent claudication associated with lower-limb ischemia. This project is a key new drug innovation initiative under the nation’s “11th Five-Year Plan” and “13th Five-Year Plan,” and Phase III clinical trials are currently underway at more than 20 centers nationwide.

        In terms of market prospects, there are currently no effective therapeutic drugs available for CLI. According to the "China Cardiovascular Health and Disease Report 2019," the number of patients with lower-limb arterial disease in China has reached 45.3 million. Assuming that approximately 10% of these patients may progress to the CLI stage, the patient population could reach 4.5 million. Based on an estimated 2 million patients receiving clinical treatment, the market size could range from 80 billion to 150 billion yuan.

        Another key project, NL005, is intended for the treatment of ischemia-reperfusion injury in acute myocardial infarction. It has already been granted invention patents in China, the United States, Europe, Japan, and South Korea. This project has been successively selected for inclusion in the national major new drug development programs during the 11th, 12th, and 13th Five-Year Plans. Currently, there are no approved products available globally; if it is launched, it will fill a significant therapeutic gap. According to publicly available data, the market size for this drug is nearly 5 billion yuan. At present, all patient enrollment for the Phase IIa clinical trial has been completed, and the Phase IIb clinical study is scheduled to commence within this year.

Seize the opportunity presented by specialized, refined, and innovative industries and embrace development opportunities.

        In November 2020, the company, in accordance with “ The fourth set of criteria—“market capitalization plus R&D investment”—has been adopted for the Select Tier, fully demonstrating the company’s robust R&D capabilities. With its intense R&D investment, NORTHLAND is currently developing 12 new bioengineered drugs targeting 14 indications, and three of these projects have already entered clinical trials. NORTHLAND is one of the leading companies on the Select Tier of the New Third Board with high innovation and technology attributes, and it is also a “specialized, refined, distinctive, and innovative” small and medium-sized enterprise in Beijing. At present, the company remains in the R&D investment phase; however, its ophthalmic pharmaceutical products have entered a healthy operational state, with rapidly increasing sales revenue, which has provided strong support for improving NORTHLAND’s overall business performance.

        In addition, as the Beijing Stock Exchange is set to open soon, all 66 companies from the Select Tier of the New Third Board will be seamlessly transferred to the Beijing Stock Exchange, becoming the first batch of listed companies. NORTHLAND, which has accurately positioned itself at the forefront of specialized, refined, distinctive, and innovative enterprises and is steadily advancing the commercialization of new drugs, will also seize development opportunities, making its future even more promising.