Life Science Strategy Group (LSSG), the leading strategic consulting and market research firm to the CRO, CDMO and biopharmaceutical services industries, is pleased to announce the launch of its new 2024 syndicated pulse report, “Biopharmaceutical Sponsor Interaction with Clinical Site Networks.”
This research report includes insights from over 60 biopharmaceutical professionals in the US and EU and explores how biopharma sponsors are interacting with clinical site networks today as well as their expectations over the next 1-2 years. LSSG also explores how biopharma sponsors’ outsourcing dollars are being spent across their external partners including CROs, Site Networks and Academia. Finally, LSSG identifies the benefits of sponsors partnering directly with Clinical Site Networks, vs. accessing them through a CRO partner.
“This study stems directly from anecdotal comments made by biopharma sponsors within our proprietary panel, and from our research we see these anecdotes are indeed validated. Sponsors are spending more time partnering directly with clinical site networks, citing benefits such as lower costs, improved communication, and stronger relationships compared to working through their CRO partners,” said Jon Meyer, Managing Member, Life Science Strategy Group. “Additionally, there are early signals that sponsors’ outsourcing dollars may be shifting towards clinical site networks, potentially disrupting the competitive dynamics between CROs such as IQVIA, ICON, Parexel, PPD, Fortrea, and Syneos Health and clinical site networks, transforming their relationship from partners to ‘frenemies’ as they vie for the same pool of sponsor dollars.”
To learn more or to download report sample pages, visit www.lifesciencestrategy.com/publications
About Life Science Strategy Group, LLC Life Science Strategy Group, LLC is a consultancy specializing in strategic consulting, market research engagements and syndicated publications across a variety of therapeutic, technology and service industries including contract research services, pharmaceutical, biotechnology, medical devices, diagnostics, and drug discovery.
Life Science Strategy Group, LLC Jon Meyer 1-800-941-6373 www.lifesciencestrategy.com
Sino Biopharmaceutical Limited (“Sino Biopharmaceutical” or the “Company”, together with its subsidiaries, the “Group”) (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2023 (the “Period”). Development Highlights — In the second quarter, the Group capitalized on the post-COVID recovery, vigorously developed its four therapeutic areas, namely oncology, liver disease, respiratory system and surgery/analgesia, and accelerated the launch of innovative products. During the period, the revenue of the Group in Q2 was up 30.0% and the adjusted non-HKFRS profit attributable to the owners of the parent saw an increase of approximately 20.7% over the same period last year.
— The Group launched a number of new products and achieved considerable sales growth from products in the fields of liver disease and respiratory system. In the first half of 2023, two innovative products were launched to market and two biosimilar drugs received marketing approval. Revenue from liver disease drugs increased by approximately 14.0% and revenue from respiratory system drugs increased by approximately 11.2% compared to the same period last year
— As of 30 June 2023, the Group had a total of 46 innovative drug candidates in the field of oncology, 8 innovative drug candidates related to the respiratory system, 7 innovative drug candidates related to liver disease, and 4 innovative drug candidates in the field of surgery/analgesia in the process of clinical trial application or above. Of these, 3 innovative oncology drug candidates and 1 innovative respiratory system drug candidate are in the marketing application stage, and 4 innovative oncology drug candidates, 1 innovative liver disease drug candidate, and 2 innovative surgery/analgesia drug candidates are in Phase III clinical trials. In addition, the Group had a total of 14 biosimilar or generic drug oncology candidates, 3 additional biosimilar or generic liver disease drug candidates, 13 biosimilar or generic respiratory system drug candidates, and 13 biosimilar or generic surgical/analgesic drug candidates in the clinical trial application or above.
— A marketing application has been submitted to the Center for Drug Evaluation (“CDE”) of NMPA for Focus V (Anlotinib hydrochloride capsules) in combination with TQB2450 (Anti PD-L1) for treating first-line small cell lung cancer in January 2023. In addition, 12 new indications for Anlotinib have entered Phase III clinical trials with marketing applications expected to be submitted within the next one to two years.
— Annike (Penpulimab monoclonal antibody) injection was approved in January 2023 for treating, in combination with chemotherapy, first-line locally advanced or metastatic squamous non-small cell lung cancer. In addition, it has another indication (third-line nasopharyngeal carcinoma) going through marketing review.
— Yilishu (Efbemalenograstim alpha) injection was approved in May 2023 for the prevention and treatment of neutropenia in cancer patients taking chemotherapy drugs. The efficacy and safety of Yilishu, as well as its innovative mechanism, were verified in three pivotal, multi-center, randomized and controlled Phase III studies conducted worldwide, which compared the efficacy and safety of Yilishu with those of drugs commonly used in clinical practice.
— Kailitong (Limaprost) tablets was approved for marketing in February 2023. It is the first drug in China to address the pathological mechanism of lumbar spinal stenosis and has the dual effect of improving neurological microcirculation and neurological functions. And it is the only small-molecule drug specifying in its package insert that it is for the treatment indication of lumbar spinal stenosis. With the launch of Kailitong, a brand-new solution is available to more than 30 million lumbar spinal stenosis patients in China, helping address a huge yet unmet clinical need.
— The clinical trial application of Lanifibranor was submitted to and accepted by CDE in March 2023. In July, Lanifibranor was included on the “Breakthrough Therapy Designation” list by CDE. The product is currently undergoing Phase III clinical trials globally, and is the first oral drug for NASH to enter Phase III clinical trials in China. It is expected to address unmet needs in the China NASH market.
— TDI01(a highly selective inhibitor of ROCK2) is currently in a Phase II clinical development trial. In April 2023, a Phase II clinical trial of TDI01 for the treatment of idiopathic pulmonary fibrosis was initiated in China. Seeing the potential of TDI01 to become a major drug, the Group will vigorously pursue its clinical development.
— All of the Group’s generic drugs with annual revenue of more than RMB500 million (excluding exclusive products) entered the centralized procurement list, thus are cleared of further centralized procurement risks.
During the Period, the Group recorded revenue of approximately RMB15.28 billion, a year-on-year increase of approximately 0.5%. Revenue for the second quarter amounted to approximately RMB8.63 billion, representing a YOY increase of approximately 30.0%. Profit attributable to owners of the parent company was approximately RMB1.26 billion. Earnings per share attributable to owners of the parent company were approximately RMB6.78 cents. Adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB1.48 billion, a YOY increase of approximately 1.2%. Adjusted non-HKFRS profit attributable to the owners of the parent for the second quarter was approximately RMB964 million, representing a YOY increase of approximately 20.7%. The Group’s liquidity remains strong, with cash and bank balances classified as current assets of approximately RMB11.58 billion, bank deposits classified as non-current assets of approximately RMB4.23 billion, and wealth management products of approximately RMB3.81 billion in total, and total fund reserves amounting to approximately RMB19.61 billion at the end of the Period.
The Board of Directors has recommended an interim dividend payment of HK2 cents per share (1H2022: HK6 cents).
Sales: The continuous manifestation of R&D achievements has led to outstanding performance in specialty therapeutic products The Group has benefited from years of in-depth research and development and continues to focus on the development of related products in specialty therapeutic areas with the aim of building its specialty brand.
During the Period, sales of oncology drugs amounted to approximately RMB4.49 billion, accounting for approximately 29.4% of the Group’s revenue. Sales of liver disease drugs increased by approximately 14.0% year-on-year to approximately RMB2.29 billion, accounting for approximately 15.0% of the Group’s revenue. Sales of surgical/analgesic medications amounted to approximately RMB2.33 billion, accounting for approximately 15.3% of the Group’s revenue. In addition, the sales contributions of products in various areas such as respiratory system, cardio-cerebral vascular medicines and others increased simultaneously, accounting for approximately 11.0%, 10.5%, and 18.8% of the Group’s total revenue, respectively.
In the field of liver disease, the Group endeavored to strengthen academic promotion of the drugs’ efficacy and safety advantages to doctors for the treatment of chronic viral hepatitis, acute drug-related liver injury and liver function abnormalities. Academic conferences at various levels helped to expand the doctor audience and increase the drugs’ among experts. Through these activities, the Group was able to actively target new patients and new markets, further driving the rapid sales growth of Tianqing Ganmei.
In the field of surgery/analgesia, the Group focused on hospital access and development in high-potential areas to expand market coverage and hospital channels, strengthening downstream development and improving the development and coverage of secondary hospitals and community healthcare facilities, which has driven the sales of Zepolas (Flurbiprofen) cataplasms to continue to grow with momentum in recent years.
R&D: Strong in-house research and development capabilities, continued focus on R&D of innovative medicines 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 surgical/analgesic system. As at the end of the Period, the Group had a total of 127 products under development, including 60 oncology products, 10 liver disease products, 21 respiratory system products, 17 surgical/analgesic products, and 19 products in other categories, of which 69 were Category I innovative products.
The Group will continue to boast strong in-house research and development capabilities and has continued to invest in business development, driving innovation and transformation with its dual-engine approach. During the Period, the Group’s R&D expenditure amounted to approximately RMB2.6 billion, accounted for approximately 17.1% of the Group’s revenue. Nearly 10 innovative drugs will be launched to market in the next three years, and more than 40 innovative drugs in research and development are expected to be launched by 2030, further strengthening the Group’s dominance in its four therapeutic areas and providing strong impetus for long-term sustainable growth.
Prospects: Driven by internationalization strategy, aiming to become a world-class innovative pharmaceutical group with revenue of HK$100 billion by 2030 As the pharmaceutical industry is expected to fully recover within the year, the Group will continue to closely monitor market trends and actively optimize its development strategies, making timely adjustments along the entire industrial chain, including procurement, production and marketing, to mitigate the impact of the pandemic. At the same time, it will continue to focus on innovation and development in the four major therapeutic areas of oncology, liver disease, respiratory system, and surgery/ analgesia, and accelerate its international deployment to build a healthier, more diversified, and sustainable revenue system.
Looking ahead, the Group will continue to adhere to its dual-pronged approach of globalization, i.e. bringing global pharmaceutical innovations to China for the benefit of Chinese patients and going global to open up new markets to accelerate the resolution of global unmet clinical needs. The Group aims to generate revenue of up to HK$100 billion by 2030 and become a world-class innovative pharmaceutical group.
Sino Biopharmaceutical Limited (“Sino Biopharmaceutical” or the “Company”, together with its subsidiaries, the “Group”) (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited Interim results for the six months ended 30 June 2022 (the “Period”).
Development Highlights — The Group achieved considerable sales growth from a number of new products and oncology products, with sales of new products launched within five years accounted for approximately 43.5% of the Group’s total revenue in the first half of 2022, up from approximately 36.9% for the same period last year.
— As of 30 June 2022, the Group had a total of 40 innovative drug candidates in the oncology field, 8 innovative drug candidates in the field of liver disease, 9 innovative drug candidates in the respiratory system field in development process for clinical application, and 1 innovative drug candidate in the field of surgery/analgesia in phase III clinical trial. Furthermore, the Group had a total of 23 biosimilar or generic drug candidates in the oncology field, 9 other biosimilar or generic drug candidates in the surgical/analgesic field, 5 biosimilar or generic drug candidates in the field of liver disease and 20 biosimilar or generic drug candidates in the respiratory system field in development process for clinical application.
— Focus V (Anlotinib Hydrochloride Capsules) was approved for the fifth indication-differentiated thyroid cancer in the first half of 2022. To date, Anlotinib 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.
— TDI01 is a highly selective inhibitor of ROCK2 and is currently in development process of phase I clinical trial for the target indications of pneumoconiosis, pulmonary fibrosis and graft versus host disease. There is no approved drug for pneumoconiosis worldwide, TDI01 is expected to fill this gap and be a boon to pneumoconiosis patients.
— SFT-1001 and SFT-1003 are two soft mist inhalation products that are currently in late clinical stage. As of 2021, there are only five soft mist inhalation products available worldwide, with a global market size of over US$3 billion and a compound growth rate of over 35% in the past five years, and the global soft mist market is expected to each US$7 billion by 2030.
During the Period, the Group recorded revenue of approximately RMB15.19 billion, an increase of approximately 5.9% against last year. Profit attributable to the owners of the parent company was approximately RMB1.92 billion. Earnings per share attributable to the owners of the parent company were approximately RMB10.30 cents. Excluding the share of profits and losses of associates and a joint venture (net of related tax and non-controlling interests), certain non-cash items and one-off adjustments, adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB1.66 billion, an increase of approximately 4.5% over that in the same period last year. Sales of new products accounted for approximately 43.5% of the Group’s total revenue for the period, while it was approximately 36.9% for the same period last year. The Group’s liquidity remains strong, with cash and bank balances classified under current assets of approximately RMB7.77 billion, bank deposits classified under non-current assets of approximately RMB6.84 billion, and wealth management products of approximately RMB7.64 billion in aggregate, the Group’s total fund reserve was approximately RMB22.25 billion at the period end.
The Board of Directors has declared the payment of an interim dividend of HK6 cents per share. (2021: HK4 cents).
Sales: Harvested years of R&D results, sales of new products as a percentage to revenue climbed The Group has obtained significant benefits from years of high research and development, and continues to focus on development of related products in the areas of specialist therapeutic. During the period, the sales revenue of new products launched within five years was approximately RMB6.61 billion, accounting for approximately 43.5% of the total revenue of the Group from approximately 36.9% last year.
During the Period, the Group’s oncology, liver disease and cardio-cerebral vascular medicines continued to lead in sales contribution. Sales of oncology medicines increased by 16.7% year-on-year to approximately 4.96 billion, accounting for approximately 32.6% of the Group’s revenue. Sales of liver disease (hepatitis) medicines and cardio-cerebral vascular medicines increased by approximately 11.1% and 13.8% year-on-year to approximately 2.01 billion and 1.55 billion, respectively, accounting for approximately 13.2% and 10.2% of the Group’s revenue. In addition, the sales contributions of products in various areas such as surgery/analgesia, respiratory system and others went up hand-in-hand. Sales of surgery/analgesia and respiratory system medicines accounted for approximately 16.6% and 10.0% of the Group’s revenue, respectively.
In the area of oncology, since its launch in 2018, the revenue from sales of Anrotinib has continued to grow rapidly and is expected to grow at a compound rate of 46% in the period between 2018 and 2022. During the Period, sales of Annike (Penpulimab monoclonal antibody injection) increased significantly against the same period last year. F-627 (Efbemalenograstim alpha, long-acting granulocyte colony-stimulating factor) is currently under marketing application stage. It provides a safety advantage over mainstream second generation products currently on the market, is expected to be approved in China in the first half of 2023.
In the area of surgery/analgesia, the Group focused on hospital access and high-potential area development, specifically on developing and increasing coverage of secondary hospitals and community healthcare facilities, driving the rapid growth of Debaian (Flurbiprofen) Cataplasms in the first half of the year.
In the area of liver disease, the Group made efforts to strengthen academic promotion so as to expand doctor coverage and enhance expert recognition, as well as actively identified new patients and new market to develop, driving the rapid growth of sales revenue of Tianqing Ganmei Injection during the Period.
R&D: Continued to focus on new products in specialist therapeutic areas The Group has continued to focus R&D efforts on new oncology, surgery/analgesia, hepatitis, respiratory system and cardio-cerebral vascular medicines. As of 30 June 2022, a total of 418 pharmaceutical products had obtained clinical trial approval, or were under clinical trial or applying for production approval. Of them, 29 were for under hepatitis, 230 for oncology, 31 for respiratory system medicines, 9 for endocrine, 16 for cardio-cerebral medicines, 3 for surgery, 4 for analgesia and 96 for other medicines.
Prospects: Two-pronged approach of independent research and development, focusing more on products with high innovation and market potential In the future, the Group will build a healthier, more diversified and sustainable revenue structure by continuing to build on traditional public hospital sales, invest more resources in new marketing channels and new marketing tools, and gradually expanding their share of revenue. In view of the potential impact of the national volume-based procurement policy on generic drugs, the Group has re-evaluated and optimised its product lines under development from the perspective of innovation and market value, focusing more on products highly innovative and with market potential.
The Group will continue to invest more resources in innovative R&D facilities, personnel and projects. Innovation has become a key driver of growth for the Group, with the share of revenue from innovative medicines expected to reach 24% by 2022. Looking ahead, the Group plans to attain revenue exceeding the RMB10 billion mark from innovative medicines by 2023, further increasing the share of revenue from them in the Group’s total. The Group aims to become a world-class innovative pharmaceutical group by 2030, with a revenue target of HK$100 billion, of which over 60% is expected to be contributed by innovative drugs.
Looking ahead, the Group is focusing on four therapeutic areas, namely oncology, surgery/analgesia, liver disease and respiratory system, and will strive to achieve its 2030 target by adopting a two-pronged approach – pursuing independent research and development and innovation-driven business 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 oncology, surgery/analgesia, hepatitis, and respiratory system.
Sino Biopharmaceutical 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.
Sino Biopharmaceutical Limited (“Sino Biopharmaceutical” or the “Company”, together with its subsidiaries, the “Group”) (HKEX:1177), a leading and innovation-driven pharmaceutical conglomerate in the PRC, has announced the donation of cash and supplies valued at RMB10 million to support Henan for flood relief and preventing epidemic.
Henan province has been afflicted by the torrential rain storm and the severe flooding has drawn widespread concern. When a place is in trouble, help from all sides come to the rescue. With this thought in mind, Sino Biopharmaceutical, in fulfilling its social responsibility and living up to its role as a pharmaceutical company dedicated to healthcare, has donated both cash and emergency relief supplies each valued at RMB5 million via the Liaison Office of the Central People’s Government in the Hong Kong S.A.R. These funds and supplies are to be used in supporting Henan province’s efforts to provide emergency medical and rescue and relief services and prevent the emergence of an outbreak of disease or an epidemic in the wake of the devastation so as to protect the lives, safety and health of the public in Henan.
Ms. Cheng Cheung Ling, Vice Chairwoman and Executive Director of Sino Biopharmaceutical, said, “Capitalising on its professional strengths in the biopharmaceutical industry, the Group will closely monitor health issues and epidemic prevention preparations subsequent to this natural disaster, and donate supplies and medicines. Sino Biopharmaceutical regards safeguarding public health as its mission and responsibility. Let’s stay together through thick and thin. Keep fighting and don’t give up, Henan!”
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 potentials, comprising a variety of biopharmaceutical and chemical medicines for tumors, liver diseases, cardio-cerebral diseases, orthopedic diseases, respiratory system diseases and parenteral nutrition.
Sino Biopharm 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 Fanny Yuen +852 2864 4853 fanny.yuen@sprg.com.hk Mandy Wong +852 2114 4900 mandy.wong@sprg.com.hk Website: www.sprg.com.hk
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