KELUN PHARMA(SZ:002422)2022-12-08 02:22R&D Structure and Strategy - The research institute has undergone significant changes since the new director's arrival, shifting from a pure imitation strategy to a more innovative approach, dividing into four major functional areas and 17 technical departments [2][3]. - The four major functional areas include: 1. Product selection and project initiation, with an information department and a business development (BD) department to gather global preclinical research data [3]. 2. Pharmaceutical research, focusing on quality, synthesis, and formulation studies [3]. 3. Evaluation department, which includes pharmacology and clinical departments for drug efficacy and safety assessments [3]. 4. Administrative support functions, including project management and registration departments [3]. Workforce and Goals - The research institute currently employs approximately 470 people, with a target to reach 1,000 employees in the next 2-3 years [3]. - The institute has established a "five-in-one" research system across different regions in China to leverage local talent and resources [3]. Project Classification and Focus Areas - Projects are classified into three categories based on importance, with Category A being the most critical [4]. - The main research directions include: 1. Brand generic drugs, targeting drugs that are available abroad but not in China [4]. 2. New drug delivery systems, which are currently a global research hotspot [4]. 3. Biotech drugs, including innovative and brand generic drugs [4]. 4. Innovative small molecules and US generic drugs [4]. Regulatory Environment and Market Dynamics - The approval process for new drugs is expected to improve, with hopes for a three-year review period for new drug applications [5]. - The domestic market is characterized by a focus on quantity over price, contrasting with foreign markets where pricing is more critical [6][9]. Production and Environmental Considerations - The company is investing in environmental solutions to address odor issues and optimize production processes [12]. - The second phase of production is expected to have a capacity of 3,000 tons, with plans for trial production in the third quarter [12][13]. Sales and Market Strategy - The sales team is being strengthened to support the introduction of new products, particularly in the clinical phase [11]. - The company aims to enhance profitability in the infusion segment by focusing on high-end products and adjusting the product mix [10].