Merck Statement on Phase II Study of Bintrafusp Alfa in First-Line Treatment of Biliary Tract Cancer

On August 23, 2021 Merck KGaA reported that based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Merck has decided to discontinue the Phase II INTR@PID BTC 055 study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC), as the study is unlikely to achieve the primary objective of overall survival (Press release, Merck KGaA, AUG 23, 2021, View Source [SID1234586978]). No new safety signals were identified.

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Health authorities and trial investigators are being notified of the decision and patients currently receiving bintrafusp alfa in the trial will be advised about next steps by their investigators.

Merck thanks the investigators and the patients and their families who participated in this clinical trial. We will share the data and analyses from this study with the scientific community in the future.

Bintrafusp alfa (M7824), discovered in-house at Merck, is currently in clinical development through a strategic alliance with GSK.

*Bintrafusp alfa is not approved for any use anywhere in the world.

The Australian Financial Review: Jefferies, Bells prepare cancer play Clarity for $300m float

On June 8, 2021 Australian cancer diagnosis and treatment hopeful Clarity Pharmaceuticals reported that it has hired investment banks Jefferies and Bell Potter to manage an initial public offering that could value it at about $300 million (Press release, Clarity Pharmaceuticals, JUN 23, 2021, View Source [SID1234586804]).

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It is understood Clarity Pharmaceuticals has told investors it is preparing offer documents for a $60 million-odd raising at about a $250 million pre-money valuation, with funds raised used for clinical trials and to commercialise its products.

China Medical System Holdings Limited 2021 Interim Results Announcement

On August 23, 2021 China Medical System Holdings Limited reported that 2021 Interim Results Announcement (Press release, China Medical System, AUG 23, 2021, View Source [SID1234586821])

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Performance Highlights

Maintained Good Business Growth: Turnover increased by 23.6% to RMB3,843.0 million; in the case that all medicines were directly sold by the Group, turnover increased by 28.7% to RMB4,269.3 million; profit for the period increased by 25.5% to RMB1,631.6 million.
Initiated the Industrial Investment in Chinese Biotech: Capitalized on strong capabilities on clinical execution, commercialization and capital strength to empower the clinical development and commercialization of domestic innovative products; made equity investment in Trinomab, would establish a joint venture, and added two natural fully human antibody drugs into the pipeline.
Upgraded the Innovative Pipeline: Deployed more than 20 innovative products, among which 9 products had been approved for marketing in the U.S./Europe, and 4 had completed or were under registration clinical trials in China. The harvest of innovation is coming.
The Professional Dermatology and Medical Aesthetic Business System Has Taken Shape: Acquired the dermatology and medical aesthetic specialty company Luqa to enrich the dermatological product portfolio and extend its reach to the medical aesthetic field; acquired Carnation, entered into collaboration with EC Healthcare and Shandong Chuangxin successively, to constantly expand the dermatology and medical aesthetic business layout.
Expanded and Optimized the Healthcare Business: Flagship stores have been launched on three mainstream cross-border e-commerce platforms, namely JD Worldwide, Youzan Mall and Tmall International. A total of 88 quality products from 14 well-known European and American brands have been put on the stores.
HONG KONG, Aug. 23, 2021 /PRNewswire/ — China Medical System Holdings Limited ("CMS", or the "Company", SEHK: 867), together with its subsidiaries (the "Group"), a well-established, innovation-driven specialty pharma with a focus on sales and marketing in China, announced its unaudited results for the 6 months ended 30 June 2021 (the "Reporting Period").

In the first half of 2021, the Group had a turnover of RMB3,843.0 million (H1 2020: RMB3,108.1 million), an increase of 23.6% over the same period last year; in the case that all medicines were directly sold by the Group, turnover increased by 28.7% to RMB4,269.3 million (H1 2020: RMB3,316.6 million). Profit for the period recorded an increase of 25.5% to RMB1,631.6 million (H1 2020: RMB1,300.5 million). Declared interim dividend was RMB0.2641 per share.

Mr. Lam Kong, Chairman and Chief Executive of CMS, said "In the first half of 2021, CMS achieved sound business growth under the synergy of positive brand images of its products, the professional academic promotion, and the compliant, efficient and refined management. With the rich experience in international development and academic promotion network resources in multiple therapeutic fields, the Group achieved in-depth development in the pharmaceutical business, while constantly expanding its business boundaries and rapidly promoting the development of the dermatology and medical aesthetic business as well as the healthcare business. At the same time, the Group actively explored on innovation and change, and initiated a new model of industrial investment in Chinese Biotech, injecting new momentum for the sustainable development of the Group, building a more proactive and promising "New CMS"."

Initiating the Industrial Investment in Chinese Biotech
Since the second half of 2017, the Group has been investing and deploying overseas innovative products in relatively mature stages due to the fact that overseas biotechnologies have outpaced China’s for many years, so as to shorten the gap between the launching time of innovative medicines at home and abroad, and improve the accessibility of Chinese patients to innovative medicines with real clinical needs. However, in recent years, under the leadership of top scientists, Chinese Biotech have continuously made breakthroughs in innovative biotechnologies via leveraging their talent advantages, flexible R&D strategies, favorable policies and capital supports. Meanwhile, their innovative products that were once in early R&D stage have gradually moved into the commercialization stage. For focusing on their own strengths and improving the efficiency of pharmaceutical industry development, an international mainstream industry ecosystem will be formed in China’s pharmaceutical industry that biotech companies will be responsible for innovation, while big pharmaceutical companies responsible for commercialization. The trend for the Group to become an incubation platform of innovative product for Chinese Biotech has emerged. Following the trend, during the Reporting Period, the Group capitalized on its previous accumulated advantages, such as efficient clinical execution, commercialization capability and capital strength, to initiate the industrial investment in Chinese Biotech, in order to empower the rapid launching of the innovative products in China.

In April 2021, the Group announced that it would make equity investment in and establish a joint venture with Trinomab Biotech Co., Ltd ("Trinomab"). Trinomab will be responsible for drug discovery and preclinical studies, while the Group responsible for clinical development, registration, and commercialization, etc. This collaboration initiated a new model for the Group’s industrial investment in Chinese Biotech.

Innovative Pipeline
The Group will continue to empower the clinical development and commercialization of innovative medicines in China through industrial investment in Chinese Biotech, equity investment in Overseas Biotech, and strategic collaboration with Global Biopharma.

In the first half of 2021, the Group’s innovative pipeline continued to expand. The Group successively reached cooperation with Trinomab on the innovative products developed through its fourth-generation antibody technology platform HitmAb, the Fully Human Anti-SA Hlα Antibody (a natural fully human antibody drug with Hlα neutralizing activity) and Fully Human Anti-HCMV Antibody (a natural fully human antibody drug with HCMV neutralizing activity). Meanwhile, the clinical development of innovative products was accelerated in China. By now, the New Drug Application of 1 blockbuster product (Diazepam Nasal Spray) has been accepted, the bridging trial of 1 blockbuster product (Tildrakizumab Solution for Injection) has met the primary endpoint, and the bridging trials of 4 blockbuster products (Cyclosporine Eye Drops 0.09% and Desidustat Tablets, Methylthioninium Chloride Enteric-coated Sustained-release Tablets, and Methotrexate Injection, Pre-filled Syringe) have been actively moved forward.

Pipeline – Launched Overseas or Under Marketing Application Review

* In July 2021, the New Medicine Application of Diazepam Nasal Spray was accepted by NMPA in China.
** In August 2021, the clinical trial application of Methylthioninium Chloride Enteric-coated Sustained-release Tablets was approved by NMPA in China.
*** In August 2021, the clinical trial application of Methotrexate Injection, Pre-filled Syringe was approved by NMPA in China.

Pipeline – Under Clinical Stages

Dermatology and Medical Aesthetic Business
The Group has been deeply engaged in the dermatology field for many years, and established rich promotion network resources, including the dermatologists and the hospital and retail channel resources. In order to fully utilize the existing advantageous resources and improve the operation efficiency in the dermatology field, the Group split the dermatology line (including the products and teams) for independent operation, so as to achieve comprehensive diseases management in the dermatology field while further expanding its business boundary to the field of medical aesthetics.

During the Reporting Period, the Group acquired Luqa Ventures Co., Limited ("Luqa"), a dermatology and medical aesthetic specialty company, to enrich the dermatological product portfolio and enter the medical aesthetic field that is featured with consumption attributes. The Group acquired Shanghai Carnation Medical Technology Co., Ltd. ("Carnation"), a R&D and manufacturing platform company of medical aesthetic devices with focused ultrasound technology, and obtained FUBA5200 Focused Ultrasound Body Contouring System, which is a non-invasive body shaping and fat reduction device using focused ultrasound technology with independent intellectual property rights. As a R&D platform for energy-based medical aesthetic devices, Carnation will continually provide cutting-edge medical aesthetic devices with focused ultrasound technology for the Group. The Group entered into a strategic collaboration memorandum with EC Healthcare, the largest non-hospital medical service provider in Hong Kong, and both sides would explore to set up a medical aesthetic training and education platform for registered medical aesthetic practitioners in China. The Group entrusted Shandong Chuangxin Pharmaceutical Research and Development Co., LTD. ("Shandong Chuangxin") for development of dermatology and medical aesthetic products, so as to promote the in-depth deployment in the dermatology and medical aesthetic field. As at 30 June 2021, the dermatology and medical aesthetic business system of the Group has been gradually enhanced, and "CMS Aesthetics", a professional dermatology and medical aesthetic company, has taken shape.

Healthcare Business
The Group continued to stringently select functional and quality healthcare products with unique ingredients globally according to medical concept and high standards, via leveraging its strengths accumulated over years, including overseas channel resources, mature product evaluation system and efficient global supply chain system. While continuously launching new products, the Group also created a number trending products. As at 30 June 2021, the Group has collaborated with 14 well-known European and American brands on more than a hundred of products, 88 of which have been launched in "CMS Health Overseas Flagship Store" or "CMS Overseas Flagship Store" on the three mainstream cross-border e-commerce platforms, JD Worldwide, Youzan Mall and Tmall International. At the same time, the Group actively explored the new retailing business mode for the healthcare products, to capitalize on the professional client resources in its promotion channels to provide professional guidance and services to consumers, to help consumers understand and cope with sub-health, and to create better consumer experience, providing consumers with healthy lives.

Commercialization System
The Group has a comprehensive commercialization system and possesses of proven successful experience in sales and promotion, having created professional brand images and good sales records for a number of branded original medicines and exclusive medicines. As a number of the Group’s innovative products are about to enter the commercialization stage, the value of its commercialization platform will be further released.

During the Reporting Period, the Group continued to explore and refine the products’ academic differentiation advantages, and organized and participated in online and offline academic conferences, to deepen the brand building. The Group also actively expanded and optimized the academic promotion network. At the same time, the Group deepened the retail market deployment and increased investment in e-commerce channels to better prepare for the prescription outflow. For medical aesthetic products and dermatology grade skincare products with stronger consumption attributes, the Group actively utilized its mature dermatologist resources as well as academic platforms to analyze the academic value and efficacy of products, built brands influence via new media marketing, and directed customer traffic through online and offline channels to facilitate the rapid growth of sales volume. In addition, the Group also strengthened construction of the compliance system as well as the professional teams, and enhanced the refined team management to facilitate the efficient implementation of marketing strategies.

As at 30 June 2021, the Group’s commercialization network covered about 57,000 hospitals and medical institutions, and more than 200 thousand drugstores nationwide.

Marketed Products
The Group’s marketed products recorded good growth. The marketed products mainly involve products under the cardio-cerebrovascular line (mainly include Plendil, XinHuoSu and Deanxit), digestion line (mainly include Ursofalk, Salofalk, Bioflor and Combizym), ophthalmology line (mainly include Augentropfen Stulln Mono Eye Drops) and dermatology line (mainly include Hirudoid). During the Reporting Period, the products under cardio-cerebrovascular line recorded a revenue of RMB1,789.0 million, an increase of 23.2% compared with the same period last year. In the case that all medicines were directly sold by the Group, the revenue of products under cardio-cerebrovascular line would increase by 29.9% to RMB2,321.1 million compared with the same period last year; the revenue of products under digestion line increased by 25.7% to RMB1,455.2 million compared with the same period last year; the revenue of the product under ophthalmology line increased by 45.9% to RMB166.0 million; the revenue of the product under dermatology line increased by 54.4% to RMB131.6 million.

In addition to the above products, the Group’s major marketed products also included products from the dermatology and medical aesthetic business, such as the prescription medical aesthetic product Aethoxysklerol (the international brand for the treatment of sclerotherapy of varicose veins with years of clinical application); the medical aesthetic products Stratamark (clinically proven topical silicone gel with efficacy and safety to prevent and treat stretch mark), Strataderm (an effective silicone gel indicated for prevention of hyperplasia and improvement of new and old scars for a wide population), Mesoestetic-Mesohyal Series (matching therapies to provide customized medical aesthetic solutions), and Neauvia Hyaluronic Acid Series (based on the cross linker technology SMART and having excellent rheology, high biocompatibility and good integrity); the dermatology grade skincare products Atopic Piel Series (a combination of washing and moisturizing to repair the damaged skin barrier and effectively relieve itching of sensitive skin).

Mr. Lam Kong concluded, "In the future, the Group will continue to invest in quality products of all business segments, improve the commercialization capability and the refined management system, and fully synergize different business segments, to promote the synchronous development of three businesses segments, including the pharmaceutical business, the dermatology and medical aesthetic business, as well as the healthcare business, and to accelerate the enterprise value growth. Meanwhile, the Group will consolidate its strengths to further enhance the abilities in project planning, clinical execution, commercialization, and capital strength, etc., so as to build a professional and efficient incubation platform of innovative medicines for global biotech companies, facilitating more domestic innovative products to produce world-class impacts, and contributing to the Healthy China construction."

Fosun Pharma Announces 2021 Interim Results

On August 23, 2021 Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH, 02196.HK), a leading healthcare group in China, reported its interim results for the first half of 2021 ("the Reporting Period") (Press release, Fosun, AUG 23, 2021, View Source [SID1234586856]).

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In the first half of 2021, Fosun Pharma adhered to the implementation of the "4IN" strategy and achieved steady development in the overall business performance. During the Reporting Period, the Group achieved revenue of RMB16,952 million, representing an increase of 20.85% YOY, of which, the income from regions outside Chinese Mainland and overseas countries accounted for 30.66%, marking a step forward on its international operation capability. The net profit attributable to shareholders of the listed company amounted to RMB2,482 million, representing an increase of 44.77% YOY. The net profit attributable to shareholders of the listed company after deducting extraordinary gain or loss amounted to RMB1,570 million, representing an increase of 20.38% YOY.

Innovative products continuously launched with China’s first CAR-T cell therapy approved for marketing

Took innovation and internationalization as its core drivers, as well as increased its R&D investment, through diversified R&D system with independent R&D, cooperative development, license introduction and in-depth incubation, Fosun Pharma accelerated the development of innovative drugs and clinical development, connected with teams of outstanding scientists, leading technologies and high-value products worldwide, to promote the development and transformation of innovative technologies and R&D, based on the overall management of R&D projects by the Global R&D center.

During the Reporting period, Fosun Pharma’s R&D expenditure amounted to RMB1,954 million, representing an increase of 15.69% YOY. In particular, the R&D expenses amounted to RMB1,562 million, representing an increase of 29.73% YOY. As at the end of the Reporting Period, there were nearly 2,600 R&D personnel, of which approximately 1,400 persons obtained master’s degree or above). The Group had 240 major pipeline innovative drugs, generic drugs, biosimilars and consistency evaluation items of generic drugs, of which 72 were innovative drugs.

In June 2021, Yi Kai Da of Fosun Kite, a joint venture, became the first CAR-T cell therapy product approved for launch in China. It is mainly used for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. In August 2021, National Medical Products Administration ("NMPA") also included its new indications in the Drug List of the Procedure for Breakthrough Therapy Designation. It shows the clinical advantages and potential of this drug in the treatment of relapsed or refractory indolent non Hodgkin’s lymphoma. Fosun Kite is expanding the indications actively, optimizing costs continuously, and exploring diversified payment methods including commercial insurance to increase the product accessibility to benefit more patients.

COMIRNATY (mRNA COVID-19 vaccine, also known as BNT162b2) has been included in the government vaccination programs in Hong Kong SAR and Macau SAR. During the Reporting Period, the vaccine has contributed revenue of over RMB500 million. Besides, Fosun Pharma has planned to supply 15 million doses of mRNA COVID-19 vaccine to Taiwan, which will be donated by the Buyers to the disease control authority for local vaccination. Meanwhile, phase II clinical trials of mRNA COVID-19 vaccine BNT162b2 in Chinese Mainland (excluding Hong Kong, Macau and Taiwan regions) and other works were also progressing in an orderly manner.

Stable growth of core pharmaceutical manufacturing business and multiple innovative products launched to improve product structure

During the Reporting Period, the revenue from core pharmaceutical manufacturing segment maintained steady growth and the product structure continued to be optimized. In the first half of 2021, the pharmaceutical manufacturing segment generated revenue of RMB12,248 million, representing an increase of 22.33% YOY. The R&D expenditure of pharmaceutical manufacturing segment was RMB1,777 million, representing an increase of 15.31% YOY, accounting for 14.51% of the revenue of the pharmaceutical manufacturing segment.

Fosun Pharma is committed to promoting innovative R&D, and is oriented towards fulfilling unmet clinical needs and improving products’ accessibility, accelerating the implementation of innovative technologies and products. After over a decade of continuous investment, many varieties such as Han Li Kang (Rituximab Injection), Han Qu You (Trastuzumab Injection), Su Ke Xin (Avatrombopag Maleate Tablets), Han Da Yuan (Adalimumab Injection) and Yescarta have been approved and sold in large quantities in the past two years,promoting sustainable growth in the Group’s performance.

During the Reporting Period, the sales volume of self-developed product Han Li Kang (Rituximab Injection) achieved substantial sales growth. In the first half of the year, it contributed revenue of RMB724 million, representing an increase of 223.21% YOY. Han Qu You (Trastuzumab Injection) and Su Ke Xin (Avatrombopag Maleate Tablets), which went launched in 2H 2020, recorded revenue of RMB325 million and RMB206 million respectively, in 1H 2021. Within the Reporting Period, revenue of Gland Pharma’s increased by 32.08% YOY, benefited from the contribution from Micafungin, Enoxaparin Sodium Injection and f new products launch. In addition, Gland Pharma continued to optimize the life cycle management of existing products and expand marketing channels, including the sales revenue of Atomolan Tablets (Glutathione Tablets) increased by 60.70% YOY.

Initial integration of diagnosis and medical aesthetic business completed with quality and efficiency improved

During the Reporting Period, Fosun Pharma’s medical device business has initially formed three major business divisions with medical cosmetology, respiratory care, and professional medical care. In the medical cosmetology field, while actively expanding its existing energy-based medical aesthetics equipment business, Sisram Medical carried out business integration on strategic tracks such as aesthetic dentistry and injectable.

In the first half of 2021, Fosun Pharma has actively promoted strategic upgrading and internal integration in the diagnosis segment. According to the business focus and characteristics of the subsidiaries under the diagnosis segment, the Group specified the positioning and functions of each of these subsidiaries as R&D and manufacturing center, differentiated instrument R&D platform, inspection service business platform and reagent manufacturing base. Centered on six major therapeutic areas (tumor, infection, digestion and metabolism, reproduction, cardiovascular, and central nervous system), Fosun Pharma has formed a cross-methodological product portfolio as well as a matrix R&D thinking that expands to different disease fields under the same methodology.

Further improved international operation capability with proportion of overseas revenue exceeds 30%

In the first half of 2021, Fosun Pharma implemented its internationalization strategy in terms of innovative R&D, BD, production, operation, and commercialization. The Group has cultivated a global BD team for deployment in frontier areas through R&D cooperation and license-in projects, while the drug clinical and registration team in the United States, Africa, Europe, and India, continued to strengthen overseas drug registration and application capabilities. At the same time, the Group accelerated the international quality system certification of domestic production lines, and deepened international marketing capabilities so as to further expand the international market. During the Reporting Period, Fosun Pharma achieved revenue of RMB5,198 million in regions outside Chinese Mainland and overseas countries, accounting for 30.66% of the total revenue.

Fosun Pharma has already set up a mature sales network with upstream and downstream customer resources in the English and French-speaking countries and regions in Sub-Saharan Africa. After years of attentive efforts, Fosun Pharma’s subsidiary, Gland Pharma has become one of India’s largest and fastest-growing companies, focusing on the production of injectables, and is active across over 60 countries.

Looking forward, Wu Yifang, Chairman and CEO of Fosun Pharma said, "The development of the entire pharmaceutical industry will be presented with both challenges and opportunities. In the second half of 2021. Fosun Pharma will endeavor to optimize product-oriented strategy, improve the Group’s R&D efficiency to strengthen the globalization, focused on innovation and international development. The Group will enhance innovative R&D capabilities, increase internationalized drug registration and declaration, and strive to develop strategic products. Whilst actively seeking opportunities for mergers and acquisitions to establish and promote the integration and synergy effects in the product lines and supply chains, the Group seeks to achieve continuous growth of its revenue and profits. At the same time, the Group will continue to optimize the operational efficiency in the healthcare service industry, accelerate the construction of competitive disciplines, enhance quality management, push forward the transformation of health industry to internet healthcare services and further promote breakthroughs in the consumer health sector so as to expand the operating scale in the segment and improve its capabilities in operation, management and internationalization."

HUTCHMED Selected as Constituent of Certain Hang Seng Indexes

On August 23, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that HUTCHMED has been selected as a constituent stock of several indexes administered by Hang Seng Indexes Company Limited ("Hang Seng"), including the Hang Seng Composite Index, in accordance with the latest index series release by Hang Seng, with effect from Monday, September 6, 2021 (Press release, Hutchison China MediTech, AUG 23, 2021, View Source [SID1234586805]).

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The Hang Seng Composite Index offers a comprehensive Hong Kong market benchmark that covers about the top 95th percentile of the total market capitalization of companies listed on the Main Board of The Stock Exchange of Hong Kong Limited. HUTCHMED has also been selected for six other indexes of Hong Kong-listed stocks, including the Hang Seng Healthcare Index and the Hang Seng Hong Kong-Listed Biotech Index.

In addition to the above indexes of stocks listed in Hong Kong, Hang Seng has also selected HUTCHMED for inclusion in six cross-market indexes, including the Hang Seng Stock Connect China 500 Index, which aims to measure the overall performance of the 500 largest Chinese companies in terms of market capitalization listed in Hong Kong and/or mainland China that are eligible for Northbound or Southbound trading under the Stock Connect schemes.