Jun 28, 2023 | Business
Sihuan Pharmaceutical Holdings Group Ltd. (the “Company” or “Sihuan Pharmaceutical”, together with its subsidiaries, the “Group”, HKEX stock code: 0460) is pleased to announce that Xuanzhu Biopharmaceutical Co., Ltd. (“Xuanzhu Biopharm”), a non-wholly owned subsidiary of Company, has received a drug registration approval from the National Medical Products Administration (the “NMPA”) of China of Anaprozole Sodium Enteric-coated Tablet for the treatment of duodenal ulcer. It is the first drug approved for marketing by Xuanzhu Biopharm, which marks a new milestone for Xuanzhu Biopharm from R&D to commercialization.
Anaprozole Sodium Enteric-coated Tablet is currently the first and only proton pump inhibitor (PPI) fully independently developed in China. Its Phase I-III clinical studies are all based on the Chinese population, so it is more suitable for Chinese patients. Anaprozole tablets can effectively inhibit the secretion of gastric acid and has the characteristics of fast onset, stable therapeutic effect, less individual variation, and long half-life. Clinical data shows that Anaprozole is metabolized through multiple CYP enzymes and non-enzymes, so the risk of drug to drug interactions is low when it is used in combination with other drugs. The drug and its metabolites are excreted through the gut and kidney, which provides safer medication options for patients with renal insufficiency.
In addition, Anaprozole Sodium Enteric-coated Tablet is not only used to treat duodenal ulcer, but also is expanding its new indication for the treatment of adult reflux esophagitis (RE). Its Phase II clinical trial has completed the enrollment of subjects, and its Phase III clinical trial is planned to initiate by the end of 2023.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group commented, “We are an innovative pharmaceutical company with roots in China and a global perspective. Our group is committed to the continuous research and development, production and commercialization of class 1 drugs with core proprietary intellectual property rights to address unmet clinical medical needs. PPI is the preferred drug choice for the treatment of peptic ulcer. The approval of Xuanzhu Biopharm’s Anerazole Sodium Enteric-Coated Tablets will bring more treatment options for patients. It is also a shot in the arm for injecting billions of dollars into the acid suppressant market. According to statistics, the number of patients with peptic ulcer in China reached over 70 million in 2021, and the total market sales size of proton pump inhibitors in China is nearly RMB30 billion, of which the oral proton pump inhibitor market is nearly RMB13 billion, which reflects that the market is relatively large. Meanwhile, based on their excellent clinical performance, Anaprozole Sodium Enteric-coated Tablet will be gladly accepted by doctors and patients and will have huge commercial potential and clinical value in the future.”
About Sihuan Pharmaceutical Holdings Group Ltd.
Founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2010, Sihuan Pharmaceutical Holdings Group Ltd. is an international medical aesthetic and biopharmaceutical company led and driven by innovation, with a leading independent production, and R&D technology platform, a rich global product pipeline and a mature and excellent sales system. Focusing on high-growth therapeutic areas such as medical aesthetics, oncology, metabolism, diabetes, cardiovascular and cerebrovascular, modern Chinese medicine and industrial hemp, it adheres to its overall strategic objective of “Adhering to the full-speed promotion of a two-wheeled strategy of Sihuan medical aesthetics and biopharmaceuticals” to build a leading medical aesthetics and biopharmaceutical company in China.
About Xuanzhu Biopharmaceutical Co., Ltd.
Xuanzhu Biopharmaceutical is the innovative drug subsidiary of Sihuan Pharmaceutical. It is an innovative pharmaceutical company with roots in China and a global perspective, focusing on major diseases such as digestion, oncology and non-alcoholic steatohepatitis, and is committed to the continuous research and development, production and commercialization of class 1 drugs with core proprietary intellectual property rights to address unmet clinical medical needs. The company has a team with extensive experience in the development and industrialisation of innovative drugs. Having been involved in the research of digestion, oncology and non-alcoholic steatohepatitis for many years, the company has a deep understanding and international vision of the development of new drugs in related fields and their future development direction. The company has two R&D platforms: small molecule chemistry and large molecule biologics. The dual engines drive the company’s innovation and development, forming a product pipeline that covers small molecule, monoclonal antibodies, bispecific antibodies, antibody-drug conjugate (ADC) and other types of products. The company adheres to the strategic concept of “innovation driven, promoting the development of new drugs in China and serving human health”, and the values of “open innovation, courageous commitment, overcoming difficulties and scientific rigor”. With a focus on unmet clinical needs, the company continues to develop new class 1 drugs with international competitiveness, and is committed to developing into a first-class innovative pharmaceutical
company with independent research and development, production, and sales capabilities.
For more information about Sihuan Pharmaceutical, please visit the Company’s website at https://www.sihuanpharm.com/
Issued by Porda Havas International Finance Communications Group for and on behalf of Sihuan Pharmaceutical Holdings Group Ltd. For further information, please contact us at sihuanpharm.hk@pordahavas.com.
Topic: Press release summary
Apr 1, 2023 | Business
Sino Biopharmaceutical Limited (“Sino Biopharm” or the “Company”, together with its subsidiaries, the “Group”) (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its audited financial results for the year ended 31 December 2022.
Development Highlights
Oncology Innovative Drugs
— Focus V (Anlotinib Hydrochloride Capsules) has been approved for five indications: third-line non-small cell lung cancer, third-line small cell lung cancer, soft tissue sarcoma, medullary thyroid cancer and differentiated thyroid cancer.
— The Phase III clinical trials of Anlotinib in combination with TQB2450 (PD-L1) for the treatment of first-line small cell lung cancer has completed interim analysis and met the pre-specified endpoint.
— In addition, 12 new indications for Anlotinib have also entered Phase III clinical trials, including the combination of Anlotinib with Penpulimab monoclonal antibody, Anlotinib with TQB2450 (PD-L1), Anlotinib with chemotherapy, and other treatment options, for which marketing applications are expected to be submitted progressively in the next one to two years.
— Annike (Penpulimab monoclonal antibody injection) injection was approved in January 2023 for the treatment of first-line locally advanced or metastatic squamous non-small cell lung cancer with chemotherapy. To date, the product has been approved for two indications: third-line classic Hodgkin’s lymphoma and first-line squamous non-small cell lung cancer. In addition, it has one indication (third-line nasopharyngeal carcinoma) under marketing review.
— F-627 (Efbemalenograstim alpha, long-acting granulocyte colony-stimulating factor) is currently in the marketing application stage. F-627 is currently the only G-CSF drug on the market that has conducted simultaneous research head-to-head with both short-acting and long-acting G-CSF in large sample sizes. Phase III clinical trials have been completed with marketing applications submitted in China and the United States. The Group expects that the marketing application will be approved in China in 2023. With its strong oncology sales team, Sino Biopharm is confident in a smooth launch and rapid market penetration of the product.
Liver Disease Innovative Drugs
— Lanifibranor (pan-PPAR agonist) is an orally-available small molecule. The product is currently undergoing Phase III clinical trials globally, and is the first oral drug for NASH that has entered Phase III clinical trials in China, to address a large clinical unmet need in the China NASH market.
Respiratory System Innovative Drugs
— Ensitrelvir (3CL protease inhibitor) is a novel oral drug for the treatment of COVID-19. The drug has the potential to become a good oral drug for the treatment of COVID-19.
Surgery/Analgesia Innovative Drugs
— PL-5, an antimicrobial peptide product that is the first newly designed non-antibiotic antimicrobial drug with a broad antibacterial spectrum. The product has completed a Phase III clinical study in China for the treatment of secondary wound infections, and the Group expects to file a marketing application within this year. When the product is launched, it will be the first antimic robial peptide product available in China.
Generic Drugs
— As of the end of the reporting period, the Group’s generic drug products, with annual revenue of more than RMB500 million (excluding exclusive products), have been included in the scope of centralized drug procurement. The stock of generic drugs that has not been included in the scope of centralized drug procurement has been cleared, hence, eliminating its risk exposure in centralized drug procurement.
During the year, the Group recorded revenue of approximately RMB28.78 billion, an increase of approximately 7.1% over last year. Profit attributable to the owners of the parent company was approximately RMB2.54 billion. Earnings per share attributable to the owners of the parent company were approximately RMB13.66 cents, a decrease of approximately 82.4% over last year. Excluding the share of profits and losses of associates and a joint venture (net of related tax and non-controlling interests), one-off adjustments for the impairment and fair value changes of certain assets and liabilities (net of related tax and non-controlling interests), fair value losses of current equity investments, share-based payments, loss on extinguishment of partial convertible bond, fair value gain of convertible bond embedded derivative component, effective interest expenses, exchange gain and fair value losses of derivative financial instruments in relation to foreign currency forward contracts of the convertible bond debt component, adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB2.99 billion, an increase of around 16.4% over last year. The Group’s liquidity remains strong, with total fund reserve at approximately RMB22.96 billion, including cash and bank balances classified under current assets of approximately RMB12.07 billion, bank deposit classified under non-current assets of approximately RMB6.35 billion, and the wealth management products of approximately RMB4.54 billion in aggregate.
The Board of Directors has recommended a final dividend payment of HK6 cents per share. Together with the interim dividend of HK6 cents already paid, the total dividend for the year amounted to HK12 cents (2021: HK8 cents).
Sales: Sales revenue contributed by new products and innovative drug products rises relied on a strong sales system
The Group continues to focus on developing innovative medicines in four therapeutic areas and has benefited significantly from the continuous and huge investment it has made in R&D over the years. During the year, sales revenue from new products (products launched within five years) launched amounted to RMB12.51 billion, a 19.8% year-on-year increase, accounting for 43.5% of the Group’s total revenue for the year, up from 38.9% for last year. Revenue from innovative drugs amounted to RMB6.75 billion, up by 20.0% year-on-year, and accounted for 23.5% of the Group’s total revenue.
During the year, the Group’s sales contribution continued to be led by drugs in the areas of oncology, surgery/analgesia, liver disease and respiratory system. Among them, the sales of oncology medicines amounted to approximately RMB9.19 billion, up by approximately 14.3% for last year, representing approximately 31.9% of the Group’s revenue. The sales of surgery/analgesia and liver disease amounted to approximately RMB4.88 billion and RMB3.84 billion, respectively, representing approximately 17% and 13.3% of the Group’s revenue, respectively. In addition, sales contributions from various areas such as respiratory, cardio-cerebral vascular medicines and others were comparable. Among them, the sales of respiratory and cardio-cerebral vascular medicines accounted for approximately 10.2% and 9.4% of the Group’s revenue, respectively.
R&D: Continued to focus on R&D of innovative medicines, emphasizes protection of intellectual property rights
The Group has continued to focus its R&D efforts on new medicines in four therapeutic areas, namely
oncology, liver disease, respiratory system and the surgery/analgesia. As of the end of the reporting period, the Group has 103 products under development, including 53 oncology products, 12 liver disease products, 26 respiratory system products, and 12 surgery/analgesia products, involving a total of 58 Category I innovative products.
The Group also emphasizes the protection of intellectual property rights. It encourages its member enterprises to apply for patent applications as a means to enhance the Group’s core competitiveness. During the year, the Group filed 1,006 new patent applications and received 280 authorized patent notices.
Prospects: Focus on main four therapeutic areas while the innovation and transformation have entered the harvest stage
As the pharmaceutical industry is likely to pick up rapidly. The Group has closely followed the development of the country, society and industry, and adjusted its development strategy in a timely manner. It has actively conducted organizational integration, optimized the internal organizational structure of the Group, and accelerated construction of business teams across different channels, in order to grow its business rapidly and deliver results in a stable manner.
According to important guidelines of the Country such as the “14th Five-Year Plan for Bioeconomy” and Key Tasks for Deepening the Reform of the Medical and Healthcare System in 2022. Sino Biopharma regards innovation and transformation as integral to its strategic development, and is focused on four main therapeutic areas: oncology, hepatitis, respiratory, and surgery/ analgesia. It has been mapping out innovative drug projects with best-in-class (BIC) and first-in-class (FIC) potential, and is driving innovative development through its dual engines: internal research and development, and commercial expansion. At present, the Group’s innovation and transformation have entered the harvest stage. In the next three years, more than 10 innovative drug products will be launched, and over 40 innovative drugs in the pipeline may be launched by 2030, further promoting the high-quality development of the Group, realizing the revenue target of HK$100 billion by 2030, and becoming a leading innovative pharmaceutical group in the world. In addition, as the cornerstone of generic drugs, the Group will continue to deploy special generic drugs that have broad market prospects and are highly competitive, and through efficient and stable production maintain steady revenue growth from generic drugs.
Under the four main strategies of “organizational integration, comprehensive innovation, internationalization, and digitalization”, the Group will further consolidate resources, improve operational efficiency, accelerate and facilitate cooperation at home and abroad, and promote global innovation and development.
About Sino Biopharmaceutical Limited (HKEX:1177)
Sino Biopharmaceutical Limited is a leading, innovative R&D-driven pharmaceutical conglomerate in the PRC. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. The Group’s products have gained a competitive foothold in various therapeutic categories with promising potential, comprising a variety of biopharmaceutical and chemical medicines for tumors, liver diseases, respiratory system diseases and surgery/analgesia.
Sino Biopharma is a constituent stock of the following indices: MSCI Global Standard Indices – MSCI China Index, Hang Seng Index, Hang Seng China Enterprises Index, Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng SCHK Mainland China Healthcare Index, Hang Seng Composite LargeCap Index, Hang Seng Composite LargeCap & MidCap Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng Stock Connect Hong Kong Index, etc. Sino Biopharm was ranked as one of “Asia’s Fab 50 Companies” by Forbes Asia for three consecutive years in 2016, 2017 and 2018.
For more information:
Strategic Financial Relations Limited
Vicky Lee +852 2864 4834 vicky.lee@sprg.com.hk
Sophie Du +852 2864 4815 sophie.du@sprg.com.hk
Website: www.sprg.com.hk
Topic: Press release summary
Aug 13, 2021 | Business
TOT BIOPHARM International Company Limited (“TOT BIOPHARM” or the “Group”; stock code: 1875.HK), a biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its unaudited interim results for the six months ended 30 June 2021.
KEY MILESTONES IN 2021 1H
In the first half of 2021, on the back of by national policies and driven by innovative R&D, the oncology drug market in China boomed and continued to gather growth momentum. The Group continued to implement its strategic plans drawing on its own strengths and competitive advantages, striving to become a leading player in the domestic ADC market. The Group speeded up R&D of ADC drugs and industrial planning and grasped market opportunities, enabling it to achieve breakthroughs in the realm of innovative drug CDMO/CMO.
Approval for Two Products Launching in the Market:
— TOZ309 (temozolomide capsules) was approved for launch in China by the NMPA in May 2021. It is a first-line medication for newly diagnosed and recurrent glioma as well as recurrent anaplastic astrocytoma. TOZ309 is the first self-developed chemical drug of TOT BIOPHARM. Together with other pharmaceutical companies in China to hasten market penetration of the product. It will at the same time prepare for renewal of the fourth round of drugs for centralized procurement in China in 2022.
— TOM218 (Megaxia(R) – megestrol acetate oral suspension) is imported by the Group, it owns the exclusive agency of the drug in mainland China, Hong Kong and Macau. The drug can alleviate the cachexia status of AIDS and cancer patients, including loss of appetite and body weight, and nausea and vomiting that sometimes occur. Compared to the solid dosage forms, oral suspensions can reduce the discomfort of patients in swallowing. Megaxia(R) had been approved for sale in the United States in 2014 and is the first high concentration megestrol acetate oral suspension approved for sale in China.
Major milestones of key products in clinical trial
— Core product TAB008 – Application for Marketing Approval Submitted and Being Processed: TAB008 is a bevacizumab biosimilar self-developed by TOT BIOPHARM for treating malignant tumors including advanced, metastatic and recurrent NSCLC and metastatic colorectal cancer. The new drug application (NDA) of TAB008 was filed in September 2020 and currently being processed by NMPA, which completed an on-site inspection and GMP-compliance inspection in January 2021. the Group expects to receive approval for marketing of the drug by end of 2021. As bevacizumab covers a number of cancers common in China, market demand would be huge.
— TAA013 – Smooth Progress of Phase III Clinical Trial: TAA013 is an ADC candidate containing trastuzumab and an emtansine derivative (Trastuzumab-MCC-DM1) for treating advance-stage or metastatic HER2+ breast cancer which could not be cured by trastuzumab and be surgically removed. In July 2020, the drug was given to the first patient in the Phase III clinical trial. To date, over 70 clinical research centers in the country are involved in the Phase III clinical trials making satisfactory progress.
Key milestones of commercial production planning
— In the first half of 2021, TOT BIOPHARM actively deployed for ADC pilot production and commercial production. It has put together highly competitive GMP-compliant pilot production facilities for mAb and ADC liquid formulation and drug substance, including the OEB-5 potency-level freeze-dried powder/liquid injection formulation (Capacity of ADC drug substance: 1g~300g/batch; Capacity of ADC formulation line: 500~5,000 vials/batch) and a GMP-compliant ADC commercial production workshop (Capacity of ADC drug substance: 1,000g-3,000g/batch; Capacity of ADC formulation line: 10,000~15,000 vials/batch).
Prominent Competitiveness of ADC Drugs
TOT BIOPHARM possesses core conjugation process technologies, a complete ADC analysis technology platform and independent analysis capabilities in respect of ADC critical metric attributes. Accordingly, we have achieved technical breakthroughs in the regulation of glycoforms, enabling precise control of the composition of each glycoform. It attributes to ensure the successful development of ADC processes and produce high quality of products.
TOT BIOPHARM has established an expert team for the R&D of conjugation process technologies of ADCs and an analysis team for complex ADC molecule structure. Boasting their extensive practical experience, successful exemplary cases and their comprehensive experience ranging from R&D, process development, clinical trials, registration and filing for approval to commercial production, and our products are at the leading position among ADCs in China.
CDMO/CMO BUSINESS ACHIEVES LEAPFROG BREAKTHROUGH
Devised One-stop Innovative Drug CDMO Solution
Despite the intense competition in the biomedical sector, TOT BIOPHARM has been able to effectively seize market opportunities and by giving full play to its open technological platform and commercial production capability, it has speeded up development of its “one-stop, localized” CDMO/CMO business, particularly in the ADC sector. It is able to capture first opportunities in the market and secure cooperation opportunities.
— TOT BIOPHARM owns core conjugation process technologies and has the ability to scale up technologies. With that advantage and capable of independent analysis of ADC critical metric attributes, the Group can guarantee the high quality of its product R&D work.
— It possesses “perfusion-batch hybrid technology” that can support commercial production of mAb drugs, including scaling up production from 25L to 2,000L directly, helping simplify the production process and shorten the production cycle, in turn enhance markedly the economic return of commercial CDMO/CMO projects.
— Priding long-term trusting relationship with partners, the Group took on various new CDMO/CMO projects in the first half of 2021, and saw substantial increase in terms of number of partners and business scale with the relevant revenue recording a substantial year-on-year growth of 330%.
— Being able to complete all the stages from R&D to putting out the end products in one plant and one place within the same production base at its Suzhou headquarter, TOT BIOPHARM managed to reduce much of the risks and difficulties in management, transportation and technological from outsourcing different procedures to different suppliers.
Strengthened Cooperation and Exchange
TOT BIOPHARM cherishes its long-term relationship and various kinds of cooperation with diverse partners and aiming to enhance core competitiveness of CDMO services.
— On 19 July, TOT BIOPHARM and BrightGene Bio-Medical Technology Co., Ltd. (688166.SH) became strategic cooperation partners, which has seen its one-stop for ADC drug CDMO service platform strengthen in favor of R&D and commercialization of innovative drugs. Pursuant to the agreement, the two parties will work together to provide clients with services starting with development of production craftsmanship, moving on to scaling up production and eventually GMP-compliant production. The cooperation realized seamless connection of industrial chains, removing the risks from cross-regional regulation, and is a marriage of strengths in terms of technologies and resources, allowing further upgrade of the CDMO service platform for ADC drugs to provide one-stop solutions to innovative drug corporations to help them reduce R&D risks and make commercialization more efficient.
CORE BUSINESS ADVANTAGES
TOT BIOPHARM has developed three core business advantages, providing a solid foundation for development of and cooperation in relation to innovative drugs.
— Three Technology Platforms and Comprehensive Industrial Value Chain
TOT BIOPHARM has three integrated technology platforms and a proven international quality Management and Registration System and registration team, plus a comprehensive industrial value chain that covers from R&D, process development, clinical trials, registration and filing to commercial production, giving it a solid foundation to speed up R&D, lay out international market presence and for its for its CDMO/CMO business.
— A Packed Product Pipeline with Huge Market Potential
At present, the Group has 12 drug candidates in the pipeline, including monoclonal antibody drugs such as TAB008 (anti-VEGF mAb), TAB014 (anti-VEGF mAb) and TAY018 (anti-CD47 mAb), and ADCs such as TAA013 (anti-HER2 ADC), for indications involving various high incidence cancers, such as non-small-cell lung cancer, breast cancer, gastric cancer, cerebral gliomas cancer and cervical cancer.
— Rare Capability of Commercially Producing mAb and ADC
Agreeing with the industrial upgrade of the Company and to meet market demand, the Group kicked off effort to expand production capacity in 2021, continuing to bolster the commercial production capacity of its antibody drugs and ADC products to prepare for the continuous expansion of the CDMO/CMO business. According to our strategic plan, we will keep on expanding our production capacity of mAb drugs to more than 16,000L.
Future Development
Dr. Liu Jun, Chief Executive Officer, Chief Science Officer and Executive Director of TOT BIOPHARM, said, “We expect TAB008, our first biological drug, to be approved for launch to market in 2021, hence we will corporate with sizable pharmaceutical plants to roll out our marketing plan. At the same time, we will push forward clinical procedures of ADC TAA013 to enrich the ADC product pipeline. With biological drug CDMO business in China at large booming, leverage on our advantage of “one-base” CDMO/CMO value chain, we will allocate our resources to optimize CDMO business in ADC field, strengthen our brand image as well as consolidate our market position.
“Looking ahead, we believe the competitive advantages of TOT BIOPHARM will become more and more obvious. We will keep presenting employees with ample room for development, and to our partners, with the best strategic solutions, and for shareholders, create value.”
FINANCIAL HIGHLIGHTS (as at 30 June 2021)
Hong Kong Financial Reporting Standards Measures:
— Revenue was RMB23.132 million, representing a year-on-year growth of 78% thanks to the Group’s proactive expansion of CDMO/CMO business heeding market changes, with relevant revenue up year-on-year growth by a substantial 330%.
— R&D expenses were RMB88.749 million, representing a year-on-year decrease of 11%, mainly attributable to the completion of Phase III clinical trials for the TAB008 project in the second half of 2020, which resulted in a year-on-year decrease in costs of clinical trials, also, R&D work completed for the TOZ309 project, there was a significant reduction of relevant expenses on R&D consumables.
— Selling expenses were RMB11.202 million, representing a year-on-year decrease of 18%, mainly attributable to the Company’s sales strategy adjustments, resulting in reduction of relevant costs and expenses.
— General and administrative expenses were RMB26.823 million, representing a year-on-year increase of 11%, mainly attributable to the increase in operating and management expenses related to related to employee, administration and taxation, etc..
— The above mentioned all in account, net loss of the Group for the first half of 2021 reached RMB115.005 million, representing a year-on-year decrease of 11%.
Topic: Press release summary
