Manufacturing capacity ready for CDMO business. The manufacturing facilitycurrently operates five antibody production lines with a total annual capacity ofover 8,000 liters. Six new antibody production lines with a total annual capacityof 30,000 liters are currently under trial run and the total capacity will reach38,000 liters. The Company would reserve 23,000 liters for Yisaipu and pipelineproducts and we believe the remaining 15,000 liters would mainly for contractdevelopment and manufacturing organization (CDMO) business. Managementbelieves its solid track record and experience in commercializing products likeYisaipu would be its core strength over other CDMOs. For the acquisition ofCDMO business of Therapure Biopharma, Management expects the deal to becompleted by the end of 2017.
Management keeping sales growth targets. For existing products, with theinclusion into the new National Reimbursement Drug List (NRDL), Managementis targeting 20-25% revenue growth rate for TPIAO and Yisaipu for 2018 amidmild ASP pressure expected. For EPIAO, ASP pressure of 5 -10% is expected as itmay be hit by secondary price negotiation. As such, Management only target midsingledigit growth for rhEPO (EPIAO and SEPO together) business.
Earlier this week, Dongfeng Peugeot Citroën's factory in Xiangyang, Hubei announced its new T STT core powertrain technology. The new technology will play an important part in the joint venture's new E Power Strategy. The new 'T' and 'STT' engine technology will be equipped on Dongfeng Peugeot Citroën vehicles powered by 1.6 L CVVT, 1.8 L CVVT, 1.2 L THP, 1.6 L THP and 1.8 L THP engines.
Byetta target to enter more Provincial Reimbursement Drug List (PRDL)and Bydureon expected to receive approval in 1Q18. While competitorVictoza (liraglutide) has been included in the latest NRDL, Byetta was notincluded. Management pointed out that Byetta has been included in the PRDL of9 provinces and the Company is targeting the product to be included in 15provinces, and finally, to be included in the NRDL. Meanwhile, Managementexpects the long acting version, Bydureon, would get approval in 1Q18 and addmomentum to the growth of the product line.
According to statistics, Dongfeng Peugeot Citroën's sales last year exceeded 550,000 vehicles. The figure represents year-on-year growth of 25 percent. This year, a total of 400,000 Dongfeng Peugeot Citroën vehicles have been sold from January to July, equivalent to year-on-year growth of 27 percent. Lyu Haitao, vice president of the JV, also revealed that the new Citroën C5 and Dongfeng Peugeot 408 will be powered by T STT technology. Over the next two years, the JV's entire product line will be powered by T STT technology.
Audit results for trastuzumab expected in 1Q18. The Company has appointeda third-party clinical study audit firm to perform an audit of all the clinical sitesand the 341 patients’ clinical data. The audit results are expected to be out in1Q18 and by then, the Company will decide if the data is enough for resubmittinga NDA to the CFDA for the product.
Despite strong sales, Dongfeng Peugeot Citroën is suffering from the problem of insufficient production capacity. While Mr. Lyu was unwilling to confirm whether or not limited production capacity has hindered the JV's sales performance, he did admit that its factories have been working at full potential to keep up with demand. According to reports, the JV manufactures 2,600 automobiles and 3,000 engines daily. Its third factory in Wuhan, Hubei reportedly manufactured 44 vehicles every hour last July. That specific factory's annual production capacity for this year is expected to exceed 220,000 vehicles.
Dongfeng Peugeot Citroën has increased its sales target for this year from 650,000 vehicles to 700,000 vehicles. President Qiu Xiandong revealed that the JV's sales in 2015 are expected to exceed 800,000 vehicles. That amount is expected to reach 1 million in 2017 and 1.5 million in 2020. While increasing its sales, the JV will also aim to broaden the usage of its new T STT technology; the JV's total emissions next year are expected to be over 20 percent less when compared with 2012's emissions./
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