12.4 C
New York

Tag: Pharmaceutical

ConV2X Blockchain in Healthcare 2022 Event Announced

Partners in Digital Health has announced the acclaimed ConVerge2Xcelerate (#ConV2X) Blockchain in Healthcare 2022, will be held on site and in person, at the...

Top News

420 with CNW — 2022 May Be Great Year for Pharmaceutical Can…

(MENAFN– Investor Brand Network) Last year was a good year for the recreational and medical marijuana industry, with major pharmaceutical ... Read More

Premier Hemp Labs and Leading CBD Retailer Call for Industry Reform and Standardized Testing

LAS VEGAS — As cannabinoids become more mainstream and the hemp and cannabis industries evolve, it should be commonplace for consumers to find high-quality options based on their product labels. […]

Kindstar Globalgene Announces FY2021 Annual Results, Revenue Increases to RMB930.67 Million

Tag Template - News Hub PRO

HONG KONG, Mar 25, 2022 - (ACN Newswire) - Kindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Company", together with its subsidiaries, collectively the "Group"; stock code: 9960.HK), a leading independent esoteric clinical testing service provider in China, today announced its audited annual results for the year ended 31 December 2021 ("2021" or the "Year").

During the period under review, the Group recorded total revenue of RMB930.67 million, representing a year-on-year increase of 4.4%. Revenue from non-COVID-19-related testing services was RMB868.57 million, an increase of 12.3%. The Group's consolidated gross profit was up by 5.4% year-on-year to RMB485.77 million, while the consolidated gross profit margin rose by 0.5% year-on-year to 52.2%. Cash and cash equivalents amounted to RMB1,796.7 million, a growth of 113.6% year-on-year. The non-COVID-19-related testing services segment recorded results of RMB197.18 million, an increase of 17.5% year-on-year. The Board has resolved not to distribute a dividend for FY2021.

Focused on specialty esoteric testing services and vigorously developed related services in six major specialty areas

Since its inception in 2003, the Group has been focusing on esoteric clinical testing services and is one of the first companies in China entering the esoteric testing service industry. During the period under review, the Group covered more than 3000 hospitals, in which over 60% are Class III hospitals, added three new laboratories and its esoteric testing volume exceeded 1.68 million, with positive growth in all six major esoteric testing specialty areas.

-- Hematology testing: The Group introduced 50 new testing items and added the Shanghai Xinnuo Baishi Medical Laboratory. During the period, the Group achieved revenue of RMB535.27 million and segment results of RMB152.57 million, representing a year-on-year increase of 14% and 15.7%, respectively.
-- Neurology testing: The Group launched six new projects covering diseases such as Alzheimer's disease and myasthenia [gravis] and also added 143 partnering Class III hospitals. The Group recorded revenue of RMB89.85 million and segment results of RMB14.06 million during the period, a year-on-year increase of 18.2 and 11.6%, respectively.
-- Maternity-related testing: The Group added the diagnosis of gestational syndromes during the period, and recorded revenue of RMB52.25 million and segment results of RMB3.55 million, representing a year-on-year increase of 0.2% and 0.5%, respectively.
-- Genetic disease and rare disease testing: During the period, the Group realized revenue of RMB43.50 million and segment results of RMB5.43 million, representing a year-on-year increase of 20.2% and 126.4%, respectively. Sales of multiple steroid hormone tests doubled year-on-year.
-- Infectious disease testing: The Group introduced 28 new testing items and added the Wuhan Kindstar Zhenyuan Medical Laboratory, achieving revenue of RMB51.97 million and segment results of [RMB]9.78 million during the period, representing a year-on-year increase of 3% and 33.2%, respectively.
-- Oncology testing: The Group launched new testing service items for various types of cancer, including intestinal cancer, cervical cancer, bladder cancer and liver cancer, achieving revenue of RMB8.62 million and segment results of RMB0.83 million during the period, 13.4% and 82.5% higher than the same period last year.
-- Others: The Group added more than 20 scientific research service projects in the areas of research services, CRO and new testing services, achieving revenue of RMB19.46 million and segment results of RMB5.99 million during the period, representing a year-on-year growth of 36.1% and 35.1%, respectively.

Persistent R&D investment to develop and expand new specialty esoteric testing business lines

As at 31 December 2021, the Group's R&D expenses amounted to RMB90.33 million, a year-on-year increase of 20.0%.The Group had 112 new R&D projects, 17 patents were pending or granted and 23 scientific research articles were published throughout the year. During the period under review, the Group stepped up its efforts in promoting the development of specialty esoteric testing services in China and expanding the scope of such services to cover cardiovascular diseases, ophthalmology, rheumatology and immunology.

-- Cardiovascular diseases: The Group focused on the R&D of biomarkers for cardiovascular diseases such as coronary heart disease, acute myocarditis and acute myocardial infarction. It also conducted verification studies on the clinical value of biomarkers.
-- Ophthalmology: The Group actively explored opportunities in ophthalmic structured esoteric testing services and its R&D covered testing solutions for hereditary oculopathy, infectious oculopathy and autoimmune oculopathy.
-- Rheumatology and immunology: The Group began the initial development of six types of disease and drug detection projects, covering sicca syndrome, rheumatoid arthritis, ankylosing spondylitis, gout, antiphospholipid syndrome and allopurinol detection.

Entered the IVD reagents field and optimized immune repertoire deployment

Wuhan Haixi Life Science Technology Co., Ltd., which the group owns a controlling stake, is a high-tech enterprise based on the R&D, manufacturing and sales of esoteric testing reagents providing systematic, comprehensive "high-precision and cutting edge" testing reagent products. The Group's main products, namely reagent kits for JAK2 genes and V617F mutations (PCR-fluorescent probe method) and reagent kits for leukemia fusion genes qualitative testing (PCR-fluorescent probe method) will enter the clinical trial stage of NMPA registration. During the period under review, the Group established its business presence in the field of IVD reagent kits in the upstream industry chain by holding shares in Wuhan Haixi Life Science Technology Co., Ltd.

As an important next-generation sequencing technology, the immune repertoire sequencing technology may bring disruptive changes to the industry in the future. During the period under review, the Group established Wuhan Kindstar Biotechnology Co., Ltd., which will focus on the application and development of the immune repertoire technology in multiple disciplines and explore the biopharmaceutical and immunotherapy pathways. In addition, to further improve its immune repertoire layout, the Group invested in Shenzhen Neoimmune Co., Ltd., a leading immune repertoire enterprise in China. Looking ahead, the two parties will commence strategic cooperation in the immune repertoire segment.

Strategy and Prospects

The Group will continue to consolidate its leading position in esoteric hematology testing in China and replicate its successful experience in hematology to expedite the growth of its specialty esoteric testing business in areas such as genetic diseases, rare diseases, infectious diseases, oncology and neurology. In the next three to five years, the Group will enter several new areas of specialty esoteric testing. At the same time, the Group is also committed to building strong relationships with a wide range of participants in the clinical esoteric testing industry (including doctors, hospitals, pharmaceutical companies, contract research institutions, academic institutions and regulatory agencies), deepening existing strategic partnerships, and expanding the existing cooperation network. Since its listing, the Group has attached great importance to opportunities for horizontal and vertical integration in the industrial chain. In the future, the Group will steadily achieve a strategic and forward-looking layout through investment, integration and empowerment, in order to boost its growth.

Huang Shiang, Chairman and Chief Executive Officer of Kindstar Globalgene, expressed full confidence in the future of China's esoteric clinical testing industry. He said, "Due to increasing public health awareness and an aging population in China, the demand for clinical tests has continued to increase. In recent years, China's esoteric clinical testing market has been growing faster than its routine testing market, and the Company has strived to develop and introduce advanced technologies to meet the enormous unmet medical demand in the country. Looking ahead, we will actively overcome the various uncertainties caused by the COVID-19 pandemic, while continuing to work hard to maintain the steady growth of our existing esoteric clinical tests, and develop and launch new services in specialty areas, thereby contributing to the precise diagnosis and advancement of treatments in specialty areas in China."

Kindstar Globalgene 2021 Annual Results Announcement:
https://www1.hkexnews.hk/listedco/listconews/sehk/2022/0325/2022032501238.pdf

Infographics for Kindstar Globalgene 2021 Annual Results Announcement:
https://mp.weixin.qq.com/s/h1rKtS_79dJ-Symd7Prz0w

About Kindstar Globalgene Technology, Inc.
Kindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Group"; stock code: 9960.HK) is a leading independent esoteric clinical testing service provider and a major provider of hematology esoteric testing services in China. It has built a comprehensive testing portfolio, a broad hospital network and advanced technology platforms and also boasts the largest esoteric testing portfolio among all independent esoteric testing providers in China, with more than 3,500 tests on its service menu and offering one of the most extensive hematology testing portfolios worldwide, including over 2,300 testing items in the field. The Group primarily targets specialty areas with substantial growth potential or that can create significant synergies with its esoteric hematology testing services, including genetic diseases and rare diseases, infectious diseases, oncology and neurology. The Group was listed on the Main Board of the Hong Kong Stock Exchange on 16 July 2021. Over the past 18 years, the Company has developed more than 1,100 testing items entirely in-house, and introduced approximately 2,400 testing items developed by or under license from third parties. The Group serves more than 3,000 hospitals in China, of which more than 1,500 are Class III hospitals, including all of the top 20 hospitals in the nation. The Group's mission is to offer a broad range of high-quality specialty testing services to patients and physicians worldwide, and to promote the application of precision diagnostics and medicine.

The Group's website: https://www.kindstar.com.cn/tc/



Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comKindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Company", together with its subsidiaries, collectively the "Group"; stock code: 9960.HK), a leading independent esoteric clinical testing service provider in China, today announced its audited annual results for the year ended 31 December 2021 ("2021" or the "Year").

Open Book Extracts Announces Completion of Largest Randomized Controlled Trial of Rare Cannabinoids for Pain

ROXBORO, N.C. — Open Book Extracts (OBX), a cGMP-certified manufacturer and distributor of the industry’s most innovative and highest quality cannabinoid ingredients and finished products, today announced the completion of its first […]

[CytoReason in Share Talk] Poolbeg Pharma PLC (AIM:POLB) Artificial Intelligence deal signed with CytoReason

24 March 2022 – Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, has signed a deal with CytoReason , a leading artificial intelligence (AI) company developing computational disease models for efficient drug discovery and development, to provide AI analysis of Poolbeg’s […]

The post [CytoReason in Share Talk] Poolbeg Pharma PLC (AIM:POLB) Artificial Intelligence deal signed with CytoReason appeared first on OurCrowd Blog.

‘Entrepreneurs have to push past inevitable failure and learn from mistakes’

From finding the right mentor to remaining resilient, China Soribe discusses what she has learned about entrepreneurship from her time at Wayflyer and starting her own business.

The post ‘Entrepreneurs have to push past inevitable failure and learn from mistakes’ appeared first on Silicon Republic.

Tag Template - News Hub PRO

Federal Appeals Court Affirms the Role of ‘Balance’ in Scheme for Extending Term of Pharmaceutical Patents

Federal Appeals Court Affirms the Role of ‘Balance’ in Scheme for Extending Term of Pharmaceutical Patents

Balance On 18 March 2022, the Full Court of the Federal Court of Australia issued decisions relating to term extensions of patents covering pharmaceutical products: Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39 (‘Ono’); and Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40 (‘MSD’).  The two decisions have (at least) three things in common.  First, both were decided unanimously by a panel comprising Chief Justice Alsop and Justices Yates and Burley.  Second, both found against the patentee, with the court reversing the primary judge’s decision in Ono granting an extension of term, and confirming the primary judge’s decision in MSD nullifying a previously granted extension of term.  And, third, both referred to the principle set out in the objects clause (section 2A) of the Patents Act 1990 that ‘the patent system balances over time the interests of producers, owners and users of technology and the public’ (emphasis added).

The scheme for extending the term of pharmaceutical patents inherently involves a balancing act.  Its primary purpose is to ensure that patentees are not excessively disadvantaged by delays in securing regulatory approval to market patented products.  For example, if a drug is not approved for use until 10 years or more after a patent application is filed, the patentee may have less than half of the standard 20 year patent term remaining to compensate for its investment in discovery and development before becoming exposed to generic competition.  On the other hand, an extended period without competition necessarily exposes the wider public to higher costs of medical treatment.  In an effort to balance these competing interests, the relatively complex provisions of the Patents Act aim to ensure that a ‘typical’ pharmaceutical patentee benefits from up to 15 years of exclusivity, by granting extensions of the patent term of up to five years, i.e. to a maximum of 25 years from filing.  (A 2013 review of pharmaceuticals patents – which the government initially declined to release – found that 53% of such patents have an effective life of 15 years, while 89% have an effective life of over 10 years.)

The primary provisions of the Patents Act governing extensions of patent term are:

  1. section 70, which sets out the conditions that must be satisfied before a patentee can apply for an extension of the term of its patent;
  2. section 71, which sets time limits for filing of applications for extensions of term; and
  3. section 77, which specifies how the duration of an extension of term is to be calculated. 

In each of Ono and MSD, the patentee sought to obtain an advantage, or avoid disadvantage, by arguing for beneficial interpretations of the extension of term provisions.  In each case they failed.  And in both cases the Full Court upheld the principle that the purpose of the extension of term scheme is to balance the competing interests of the patentee of a pharmaceutical substance against the public interest in the unrestricted use of the pharmaceutical invention after expiry of the patent.  In Ono, in particular, the Full Court rejected the proposition that sections 70, 71, and 77 should be construed to achieve a commercial outcome for the patentee.  In MSD the Full Court again invoked the principle of ‘balance’ in declining to permit an extension of term based on a later Australian marketing approval, in circumstances where the patentee had already obtained the benefit of an ‘export only’ approval of a substance falling within its patent claims with an effective life of over 15 years.

The relevance of the Full Court’s focus on balancing of interests, and its references to the objects clause, could extend beyond these cases.  The three judges here are all among the five who recently heard the appeal in the Thaler ‘AI inventor’ case, in which the competing interests of developers and owners of ‘invention machines’, and of the broader public (who might not see the same benefit in granting patent monopolies on automatically-generated inventions), are potentially at stake.  It will be interesting to see whether they adopt a similar approach to weighing up the balance of interests in that case, also.

Read more »

Avista Public Acquisition Corp. II (AHPA) to Combine with Ligand Pharmaceuticals

Avista Public Acquisition Corp. II (NASDAQ:AHPA) has entered into a definitive agreement to acquire Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) to spin-off its antibody discovery business OmniAb, Inc. at a pre-money equity valuation of $850 million. The San-Diego based biopharmaceutical company is focused on developing technologies that help pharmaceutical companies discover medicine. Ligand’s OmniAb platform provides
Read More

To access this post, you must purchase a Monthly or Yearly SPACInsider Subscription, or log in if you're a member.

Marlena Haddad

Kingworld Medicines Group Issues Positive Profit Alert for 2021

Tag Template - News Hub PRO

HONG KONG, Mar 23, 2022 - (ACN Newswire) - Kingworld Medicines Group Limited (stock code: 01110.HK), a leading omni-channel enterprise providing greater health products and services in China, issued today a positive profit alert as it expects to record an approximately 155% to 160% increase in profit attributable to owners of the Company for 2021, as compared to RMB11.7 million for 2020.

The positive profit alert was based on preliminary assessment of the unaudited consolidated management accounts of the Group for 2021 and information currently available to the Board. The Board attributes the increase in profit mainly to the market recovering from the COVID-19 pandemic outbreak pushing up the turnover and gross profit of imported branded pharmaceutical and healthcare products distributed in China in 2021 by approximately 45% to 50% and approximately 65% to 70%, respectively, against the previous year. The management of the Company also adopted effective measures against the COVID-19 pandemic outbreak to reduce costs and improve efficiency, thus enhancing the Company's overall competitiveness.

Shenzhen Dong Di Xin Technology Company Limited, Kingworld Medicines' non-wholly owned subsidiary, is a manufacturer producing various medical devices including infrared thermometers. Affected by a drop in sales of anti-Pandemic devices, the company is expected to record an approximately 34% to 39% decrease in profit for 2021 as compared with the previous year.

About Kingworld Medicines Group Limited
Kingworld Medicines (stock code: 01110.HK) has devoted more than 20 years to developing a comprehensive greater health industrial supply chain system. Its business covers over 34 provinces and municipalities in China, and it is among the Top 100 Import Enterprises of Pharmaceutical and Healthcare Products and Top 5 Sales of Imported Chinese Patent Medicine in the country. In-keeping with the new normal of consumption upgrade, it has constructed a complete online and offline new retail ecosystem. Its subsidiary Shenzhen Kingworld Medicines is a reputed distributor of branded pharmaceutical and healthcare products imported from overseas, including Nin Jiom Loquat Herbal Cough Syrup, Taiko Seirogan, Kingworld Imada Red Flower Oil, and Culturelle probiotics from the United States, etc., in the China market.

For further information, please visit http://www.kingworld.com.cn .



Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comKingworld Medicines Group Limited (stock code: 01110.HK), a leading omni-channel enterprise providing greater health products and services in China, issued today a positive profit alert as it expects to record an approximately 155% to 160% increase in profit attributable to owners of the Company for 2021, as compared to RMB11.7 million for 2020.

Cannabis in Spain: ICBC Notes

This past weekend, I was finally able to attend the renowned International Cannabis Business Conference (ICBC) here in Barcelona, Spain. The event had been cancelled for two consecutive years due to the pandemic. I attended interesting panels on everything from cannabis 3.0, to cannatech, to the current challenges of cannabis clubs in Spain. I want

The post Cannabis in Spain: ICBC Notes appeared first on Harris Bricken Sliwoski LLP.

Essex Bio-Technology Announces 2021 Financial Results

Tag Template - News Hub PRO

HONG KONG, Mar 22, 2022 - (ACN Newswire) - Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2021.

Highlights
-- The group's turnover surged 67.4% to HK$1,637.7 million, Profit-After-Tax lifted 58% to HK$346.0 million;

-- Sales coverage increased to around 10,500 hospitals and 2,110 pharmaceutical stores in the PRC;

-- Obtained an approval for the registration and commercialisation of the preservative-free unit-dose Moxifloxacin Hydrochloride Eye Drops in the PRC;

-- Significant progress in R&D program, 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage as the below:
SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021;
Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC);
Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC);

-- Holds a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents;

-- Completed the acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules.

Significant progression in Financial Performances

Essex achieved significant progression and encouraging performances amid the COVID-19 pandemic and macro uncertainties. For the year ended 31 December 2021, the Group recorded a turnover growth of 67.4% to approximately HK$1,637.7 million as compared to approximately HK$978.1 million in 2020, indicating a strong recovery to the pre-COVID-19 operating level. In tandem with the increase of turnover, the Group achieved an increase of 58% in after-tax profit to approximately HK$346.0 million as compared to approximately HK$218.9 million in 2020.

Turnover of Ophthalmology and Surgical Segments Surged 60.6% and 72.6% respectively
The Group's turnover is primarily made up from the segments of Ophthalmology and Surgical (wound care and healing). The core products that are of current growth driver under each segment are:

1. Ophthalmology - Beifushu series (Beifushu eye drops, Beifushu eye gel and Beifushu unit-dose eye drops), Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops and Shilishun(Iodized Lecithin Capsules); and

2. Surgical (Wound care and healing) - Beifuji series (Beifuji spray, Beifuji lyophilised powder and Beifuxin gel), Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules.

The sectoral turnover of Ophthalmology and Surgical is approximately 41.1% and 58.9% of the Group's turnover, respectively. The combined turnover of the Group's flagship biologics, Beifushu series and Beifuji series, the basic fibroblast growth factor (bFGF) based biologic drugs, represented about 84.3% of the Group's total turnover, of which Beifushu series and Beifuji series accounted for 26.1% and 58.2% of the Group's turnover, respectively. The remaining 15.7% of the Group's turnover is mainly contributed from sales of Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops, Shilishun Iodized Lecithin Capsules, Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules, collectively. Ophthalmology segment contributed approximately HK$673.3 million to the Group's turnover for the year ended 31 December 2021, representing an increase of 60.6% as compared to approximately HK$419.2 million in 2020. Surgical segment recorded a total turnover of approximately HK$964.4 million for the year ended 31 December 2021, representing an increase of 72.6% as compared to approximately HK$558.9 million in 2020. The increase was attributable to the resumption of clinical operations in hospitals to normalcy in the PRC and the expansion of sales.

The selling of Xalatan Eye Drops and Xalacom Eye Drops would be discontinued in 2022 that contributed approximately 2% to the Group's gross profit for the year ended 31 December 2021.

The Board proposed a final dividend of HK$0.055 (2020: HK$0.05) per ordinary share to be approved at the upcoming annual general meeting of the Company.

Mr. Patrick Ngiam, Chairman of Essex, said, "2021 has been a year full of diverse challenges. Our part of the world has been affected by extended lockdowns and border closures under COVID zero regime, even as other regions begun to reopen. Despite yet another difficult year inflicted by the pandemic of COVID-19 on us all, the tenacity, drive and leadership in our DNA was able to deliver greater stakeholder value. The Group has achieved significantly improved financial performances in the financial year ended 31 December 2021. This is a testament that the Group's business is resilient and was able to recover swiftly to the pre-COVID-19 level after the normalcy of the clinical operations of hospitals resumed in the PRC since September 2020."

Significant Business Development Activities

The Group is committed to pragmatically investing in new products and technologies to strengthen the Group's product and R&D pipeline as near to mid-term growth driver in ophthalmology and long-term plan for new therapeutics in oncology. During the year under review, major investments in ophthalmic products are outlined as follows:

Investment in Ophthalmology

Significant progress for SkQ1's second phase 3 clinical trial
In 2018, the Group entered into a co-development agreement with Mitotech S.A. ("Mitotech") and Mitotech LLC for the United States Food and Drug Administration (the "US FDA") phase 3 clinical trial of an ophthalmic solution containing SkQ1 for dry eye disease. As disclosed in the announcement of the Company dated 24 February 2021, positive outcome was achieved during second phase 3 clinical trial (VISTA-2). The clinical trial study repeated statistically significant positive results on key predefined secondary end-point (Central Corneal Fluorescein Staining). The Board is enthusiastic about the read-out of clearing of central staining of the cornea (defined as zero staining in central cornea), which reveals the potential of SkQ1 in addressing oxidative stress in dry eye diseases. Following the positive trial outcome of VISTA-2, Mitotech has planned a pivotal trial (VISTA-3), which will commence once Mitotech's management team has fully assessed there is no potential disruption to trial centres and patient recruitment during the ongoing COVID-19 pandemic. However, recent developments in Ukraine have led to governments and industries reacting to business relationships with Russia in a way that could potentially induce delays in Mitotech's VISTA clinical trial program.

HLX04-O approved for phase 3 clinical trial
In 2020, the Group entered into a co-development and exclusive license agreement with Shanghai Henlius Biotech, Inc. to co-develop a pharmaceutical product that contains an anti-vascular endothelial growth factor ("anti-VEGF") as a drug substance, which is intended for the treatment of exudative (wet) age-related macular degeneration ("wet-AMD"). As at the date of 22 March 2022, the recombinant anti-VEGF humanised monoclonal antibody injection HLX04-O ("HLX04-O") for the treatment of wet-AMD has been approved to commence the phase 3 clinical trial in Australia, the United States, Singapore, Russia, Serbia and European Union countries such as Hungary, Spain, Latvia, the Czech Republic and Poland. Also, the first patient has been dosed in a phase 3 clinical study for HLX04-O for the treatment of wet-AMD in the PRC.

Ophthalmology business is expected to be further strengthened by the acquisition of Shilishun Iodized Lecithin Capsules

The successful acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules will enable the Group to strengthen its ophthalmology business.

Market Development

Robust Market Access Capability
Over the years, the Group has been relentlessly investing in establishing and strengthening its market access capability. As at 31 December 2021, the Group maintains a network of 43 regional sales offices in the PRC and a total number of about 1,265 sales and marketing representatives, out of which 64% are full-time employees and 36% are on contract basis or from appointed agents.

More Extensive Healthcare Network for Product Prescription
During the year under review, the Group's therapeutic products are being prescribed in more than 10,500 hospitals and medical providers, coupled with approximately 2,110 pharmaceutical stores, which are mainly located in the major cities, provinces and county cities in the PRC.

Further Investments to Strengthen Competitiveness and Customer Base
For achieving a sustainable traction on growth for currently marketed products as well as for near-term to mid-term new products being commercialised, the Group initiated investments to improve its competitiveness and widen its customer base under the following plans:

-- Investing in clinical observation programs for affirming additional clinical indications of its commercialised products;
-- Reaching out to market in lower-tier cities;
-- Cultivating pharmaceutical stores, where possible, as complementary sales channel; and
-- Building on-line platform for medical consultation and e-prescription for patients with chronic diseases under its healthtech initiative.

The Group has initiated its market access expansion to Southeast Asian countries by setting up a base and expanded its presence in Singapore since 2020.

Research and Development

The Group renewed its R&D's vision, emphasising the dedication to science and innovation, with a mission to develop therapeutics that would meet unmet clinical and/or commercial needs. The Group concurrently kick-started a 5-year (2021 to 2025) R&D's development plan to further strengthen its R&D capability and its position in Ophthalmology.

As at 31 December 2021, there are 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage. The 3 ophthalmology programs listed below are targeted as mid-term growth driver.

1. EB11-18136P: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021

2. EB11-15120P: Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC)

3. EB12-20145P: Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC)

As at the date of this announcement, the Group has obtained a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents.

The Group currently has diversified its R&D resources to multiple research sites in Zhuhai (PRC), Boston (United States), London (United Kingdom) and Singapore which supports not only our pursuit for new therapeutics but also our acquisition of global talent.

Prospects

Looking ahead, the Group will continue to monitor the circumstances under the uncertainty of COVID-19 in 2022. Its strong team spirit and dynamic leadership have provided it with the capacity to navigate these turbulent times, and capture any opportunities in the ever changing world. The Group remains highly dynamic in delivering positive results in the coming year.

"COVID-19 remains a major concern in 2022 globally. We continue to monitor the situation and will take appropriate actions to overcome any unforeseen challenges. Barring the unforeseen circumstance, the Group remains focus on executing its plans and delivering progressive results. I would like to take this opportunity to express my sincere gratitude to all stakeholders, business associates and valued customers for the trust, support and cooperation accorded to us, and each and every member of the Group for their relentless efforts rendered in shaping the Group into being a progressive and promising pharmaceutical player.", said Mr. Patrick Ngiam.

Full version of Essex's FY2021 Annual Results Announcement can be downloaded at: https://www1.hkexnews.hk/listedco/listconews/sehk/2022/0322/2022032200780.pdf

About Essex Bio-Technology Limited (Stock Code: 1061.HK)
Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic rb-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Shilishun Iodized Lecithin Capsules etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 10,500 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.

Media Enquiry:
Strategic Financial Relations Limited (Website: http://www.sprg.com.hk)
Shelly Cheng +852 2864 4857 shelly.cheng@sprg.com.hk
Yan Li +852 2114 4320 yan.li@sprg.com.hk
Jill Cheung +852 2114 4870 jill.cheung@sprg.com.hk
Media: media@essex.com.cn

Investor Enquiry:
Investor Relations: investors@essex.com.cn


Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comEssex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2021.

AUDACIOUS Opens Medical Cannabis Clinic in Southeast Asia, Expanding Global Footprint into Thai Medical Cannabis Market

LAS VEGAS – Just as the dynamic Thai medical cannabis market begins to blossom, AUDACIOUS and Thai-based partner Golden Triangle Health have partnered to open the first Herbidus Medical Center […]
Tag Template - News Hub PRO

Recent articles

spot_img