Fudan-Zhangjiang Announces 2013 Annual Results

HONG KONG, March 26, 2014 /PRNewswire/ --

Revenue Surges 79% to Approximately RMB415,925,000

Profit Attributable to Shareholders Recorded Strong Growth to RMB87,218,000 with 64% Increase

Successful Accomplishment on Transformation from R&D and Commercialization Formed Complete System Featuring R&D, Product Manufacturing and Marketing

The leading bio-pharmaceutical company in China, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. ("Fudan-Zhangjiang" or the "Company", together with its subsidiaries, collectively as the "Group") (Stock Code: 1349), today announced its annual results for the year ended 31 December 2013 (the "year under review").

During the year under review, the Group's revenue increased by 79% to approximately RMB415,925,000. Gross Profit increased 84% to approximately RMB383,518,000. Gross profit margin rose 2 points to 92%. The profit attributable to shareholders increased 64% to RMB87,218,000. The basic earnings per share increased 35% to RMB0.1009. During the year under review, the revenue of the Group from the sale of medical products and the provision of related ancillary services was RM410,847,000, increased by 82% compared with last year. The major products of the Company, ALA^®(ALA) and Libod^®(Doxorubicin liposome), have contributed 43% and 52% to the revenue of the Group respectively. The board of directors of the Group does not recommend the payment of a final dividend for the year ended 31 December 2013.

Mr. Wang Haibo, Chairman of the Board, Executive Director and General Manager of Fudan-Zhangjiang, said, "During the year under review, with the Group's mission, 'The more we explore, the healthier human beings will be', the Group made strategic adjustments in research and development ("R&D") of drugs to create a kind of drugs development model which is based on gene background and molecular mechanism analysis of diseases and relies on the technology of genetic engineering, photodynamic drug and Nano-drugs. Furthermore, the successful listing on the Main Board marked a major milestone of the Group, and benefited to the future growth, flexibility of corporate financing and business development of the Group."

In the aspect of genetic technical platform, the Group enhanced the ability on building Genetic technical platform during the year under review, and commenced the research on Anti-sclerostin mab and PCSK9. On the other hand, the Clinical Trial Application for High bio-activity recombinant human TNF receptor 2-Fc fusion protein mutant for the treatment of arthritis has been submitted during the year under review and the application is currently under review. The drug is mainly used to treat self-immunological diseases, such as arthritis. The potential market is enormous. The Group possessed independent intellectual property right of the drug and applied for PCT patent, it is one of the key R&D projects of the Group. Moreover, the Group restarted the phase I clinical trial of PTH for the treatment of osteoporosis during the year under review. At the same time, the indication of osteoarthritis was also in the research. Besides, since the antibody-drug conjugate drugs have shown obvious advantages on tumor treatment in clinical trials, which is much better than the effect of the conventional antibody plus chemotherapy drugs. In order to follow the development trend in bio-pharmaceutical area, CD30-MMAE for the treatment of tumors has entered into pre-clinical study.

The Group strived to expand the drugs development based on photodynamic technical platform. The first commercialization project of the Group, therapy of Aminolevulinic Acid Hydrochloride combined with photodynamic technology, being the first photodynamic drug for the treatment of condyloma acuminate in the world, ALA was launched with good response from the market. The Group is further expanding to other indications such as CIN infected by HPV, it has entered into the phase I clinical trial at the moment. Meanwhile, the pre-clinical study adjuvant therapy with Aminolevulinic Acid Hydrochloride for brain gliomas and treatment for basal cell carcinoma were commenced as well. Furthermore, the therapy of ALA combined with photodynamic technology was recorded in the 8th edition of 《Dermatovenercology》in March 2013 and relevant clinical treatment guidance. The Group is preparing the international registration for ALA. In addition, FuMeiDa^® (Hemoporfin), the first photodynamic drug for the treatment of port wine stain in the world, the Group  has obtained the New Drug Certificates issued by the State Food and Drug Administration and plans to launch for sale in the first half of 2015. Besides, Duteroporphyrin for the treatment of tumors has completed the phase I clinical trial and it is going to enter the clinical phase II soon. In the meantime, the Group will design several laser and LED equipment for the treatment of different indications, while the Group cooperated with academic institutions to set up software and hardware repository for photodynamic drugs.

Regarding to nano technical platform, the Group further developed drugs based on new delivery technique during the year under review. Libod^® for the treatment of AIDS-relating Kaposi's sarcoma, breast cancer and ovarian cancer is currently under registration in US and obtained the approval of US Food and Drug Administration (FDA) for clinical research in January 2014. Moreover, the Vincristine sulfate liposome (LVCR) for the treatment of malignant tumors has entered into phase I clinical trial, while Nanoparticle Albumin-bound Paclitaxel for the treatment of tumors, has entered into pre-clinical study. Meanwhile, Echogenic liposomes containing Xenon for the treatment of stroke, a project cooperated with American company and research institution has entered into the pre-clinical study.

All the product lines of the Group passed GMP Certification of China Food and Drug Administration during the year under review. Taizhou Pharmaceutical, the subsidiary of the Group has constructed two production lines for the material and injection of Hemoporfin. In order to fully utilize the capacity of production lines, the Group will choose several generic drugs which can be produced on the same production line with Hemoporfin for registration. The Group will start to apply the certification of US FDA in 2014 for the production lines in Shanghai and Taizhou.

In the aspect of intellectual property rights, the Group applied for one invention patent, and has been granted seven invention patents in China, Europe, Japan, Australia, Canada, America and Russia during the year under review. As at 31 December 2013, the Group has cumulatively applied for 61 invention patents and has been granted 34 invention patents. Meanwhile, The Group has always been improving its ability of new drugs development in light of the industrial policies of the State. During the year under review, the numerous R&D and commercialization projects of the Group obtained various grants from governments.

In the area of marketing promotion, the Group has implemented adjustment on market academic promotion by using WeChat platform for online academic exchange, clinical case and standard practice video sharing, interactive consultation between doctors and patients and etc online service mechanisms. Currently, more than 4,000 dermatologists joined photodynamic technology WeChat communication platform, enhanced positive significance to products promotion and brand recognition building of the Group.

Mr. Wang concluded, "Looking ahead, we realized "Commercialization advanced scientific exploration" which is spearheaded by the Group and together with drug developers, international top scientists and specialists to explore gene variation and molecular mechanism of the disease in specific areas will rapidly and effectively enhanced the ability of drugs development of the Group and optimize drugs development model. In addition to the importance of clinicians' exploration and experiences on new drugs development, regarding to the treatment of complicated diseases such as angiocardiopathy and dermal disease. We will cooperate with outstanding clinicians and hospitals, searching the representable samples of genetic diseases in China for gene research and finding pathogenic gene, with the research commencement on molecular mechanism, animal models and drug leads in the international first-class laboratory cooperated with us. The Group will continue devoting efforts to R&D on projects with proprietary intellectual property rights in the future and continuously strive to extend the Group's business, providing useful assistance on the treatment to patients and generating remarkable returns for our shareholders."