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Yingli Pharma Announces NMPA Approval of New Anti-cancer Drug Linperlisib

The first highly selective PI3Kδ inhibitor in China

SHANGHAI, CHINA Media OutReach 9 November 2022Shanghai Yingli Pharmaceutical Co., Ltd. (the “Company” or “Yingli Pharma“) is pleased to announce that linperlisib, trade name因他瑞®, a novel phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, has been approved by the National Medical Products Administration (NMPA) of China on November 9 for the treatment of relapsed/refractory follicular lymphoma (R/R FL) in patients who have received 2 or more prior systemic therapies. The NDA approval validates Yingli Pharma’s strong innovation capabilities and fulfills the company’s objectives to bring new treatment options to patients and their families.

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[Photo: NMPA Approval of linperlisib]

Yingli Pharma has entered into strategic partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), a leading pharmaceutical company with well-established oncology sales and marketing network, to commercialize因他瑞® in China.

A safe and effective treatment choice for FL patients

Linperlisib is a next generation phosphoinositide 3-kinase delta (PI3Kδ) inhibitor independently developed by the Company. PI3Kδ plays a key role in the tumor immune cell proliferation and survival, making it a potent target for non-Hodgkins lymphomas. Treatment options for R/R FL patients, a major form of non-Hodgkins lymphoma, are extremely limited in China. In 2020, linperlisib was awarded NMPA Breakthrough Therapy status for the treatment of R/R FL in China. In addition, it received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic lymphocytic leukemia/ small lymphocytic lymphoma and T cell lymphoma.

In the pivotal R/R FL Phase II clinical trial in China, linperlisib-treated patients had an 79.8% overall response rate, a 96.6% disease control rate, a median Time to Response of 1.9 months, a median Progression Free Survival of 13.4 months, Duration of Response of 12.3 months and a 91.4% overall survival rate at 12 months1. Linperlisib was well-tolerated with a differentiated and manageable safety profile, with low immune-mediated toxicities. In the linperlisib-treated patient safety dataset of the pivotal study, the most common (>15%) non-hematologic treatment related adverse events (TRAE) (Any Grade/ Grade3) were hypertriglyceridemia (25%/3%), ALT elevation (19%/2%), AST elevation (15%/2%), diarrhea (15%/2%), and pneumonia (15%/15%). The most common (>5%) hematologic TRAEs (Grade3) were neutropenia (15%), leukocytopenia (5%), and lymphocytopenia (5%).

“We are pleased to provide a new treatment option for patients with R/R FL with the approval of linperlisib. As linperlisib is the first innovative drug independently developed by Yingli Pharma, the NDA approval is a significant milestone”, said Dr. Xu Zusheng, General Manager and President of R&D of Yingli Pharma, “We would like to thank the patients, clinicians, and scientists for their generosity and great effort in the clinical development of linperlisib. It is a convenient once daily oral drug which demonstrated favorable safety, promising efficacy and great patient compliance. Yingli Pharma looks forward to in-depth collaboration with Hengrui Pharma to bring forth a full commercialization of 因他瑞® and extend the clinical development into additional indications.”

Dr. Lianshan Zhang, Deputy General Manager and President of Global R&D of Hengrui Pharma, said, ” We are delighted with the NDA approval of linperlisib (因他瑞) for R/R FL. This approval is an important step for Hengrui Pharm to build a strong hematology franchise with an enriched pipeline. As Hengrui Pharma focuses on patient-centered R&D and innovation, we will continue to evaluate new indications for linperlisib, and combinations with the company’s existing products to potentially benefit more patients.”

1. Lugui Qiu et al. 2022EHA.Abstract 1119

Hashtag: #YingliPharma

About Yingli Pharma

Shanghai Yingli Pharmaceutical Co., Ltd. is a technologically innovative biopharmaceutical company founded in 2011 and located in the National Biomedical Industry Base of Shanghai Zhangjiang InnoPark. With the Chinese government promotion of healthcare reforms, the Chinese pharmaceutical industry has gradually transformed to include the biopharmaceutical sector of innovation. The NDA approval of linperlisib is a significant milestone for this national effort and demonstrates the Company’s strong innovation capability for drug development. Yingli Pharma has established a rich and independently-developed pipeline of novel oral agents for oncology and metabolic diseases. The Company has more than ten drugs under development, including more than 100 independent intellectual property rights, with three of the investigational agents in clinical stage in China and abroad.

For more information, please see:

Laos is One of National Geographic’s Top Five Spots for Slow Travel in 2023

Image by wirestock on Freepik

After selecting Laos as one of the 25 most breathtaking places one should visit in 2023, the popular magazine has curated a new list that features the country once again.

The Société Royale d’Encouragement du Cheval (SOREC) organizes the 8th edition of the Morocco International Meeting of horse racing (MIM), November 19th and 20th, at Casablanca-Anfa Racecourse

This major event welcomes a list of prestigious Moroccan and international participants

CASABLANCA, MOROCCO – EQS Newswire – 9 November 2022 – The Société Royale d’Encouragement du Cheval (SOREC) (https://www.SOREC.ma) will host the 8th edition of the Morocco International Meeting (MIM), an event organized annually on the third weekend of November.

This major event welcomes a list of prestigious Moroccan and international participants. SOREC has mobilized the best resources to organize this event in accordance with the international standards, as it continues its mission to strengthen the role of MIM in promoting Moroccan horse racing.

Our major objective is to raise awareness about Moroccan horse racing on the international scene. We are particularly happy to be able, once again, to welcome the international horse racing community. Their trust in the Kingdom’s horse racing industry, as well as their interest in the Morocco International Meeting, have strongly contributed to positioning this event among the most important stages of the racing international calendar,” says Mr. Omar Skalli, CEO of SOREC.

An international program

The Morocco International Meeting program will feature 14 races—including 8 international races—with a total prize money of €750.000. The first day will be dedicated to Thoroughbreds and the second to Purebred Arabians.

The highlight races of the weekend will be the Grand Prix of His Majesty The King Mohammed VI for Purebred Arabians and for Thoroughbreds.

Purebred Arabian Day will offer three additional major prizes:

  • Grand Prix HRH The Crown Prince Moulay El Hassan;
  • Grand Prix HRH The Prince Moulay Rachid;
  • Prix The UAE President Cup.

Thoroughbred Day will host the Grand Prix SOREC, part of the prestigious international competition series “Défi du Galop”.

Optimal benefits for participants

SOREC will provide international participants with significant support, notably for the transportation of horses and a complete welcome program.

Hashtag: #SOREC

About SOREC

The Société Royale d’Encouragement du Cheval (SOREC) was created in 2003 as a public company under the supervision of the Ministry of Agriculture, Fisheries, Rural Development, Water and Forests. SOREC has established a unique business model on the global scene, pursuing multiple missions: Breeding supervision and improvement in the National Stud farms, Horse racing management, betting management; and the construction and operation of horse racing infrastructures. SOREC strives to positioning the equine sector as a driving force for development in rural areas, directing actions to promote breeds and monetize the role of horses to support the emergence of ecosystems that are economically viable and financially independent.

That Luang Festival Returns to its Pre-Pandemic Glory This Year

An aerial shot of the That Luang stupa captured during the festival. Photo Credit: Phoonsab Thevongsa

That Luang festival returned to its pre-pandemic splendor this year, resulting in thousands of people from across the country and abroad flocking in to experience the festivities.

In N Out Storage stays bullish in self-storage business with new branch expansion

HONG KONG SAR – Media OutReach – 9 November 2022 – In N Out Storage, a Hong Kong based privately owned self-storage company, casts its vote of confidence in the City’s self-storage sector with its latest expansion into Tin Hau. Operates mostly with self-owned properties, this is the fourth expansion in 2022 following the opening of the San Po Kong branch in August.

The Tin Hau branch provides one hundred storage units that are accessible 24/7. In N Out’s existing portfolio of nine storage locations and over twenty storage facilities spans across Hong Kong Island and Kowloon with locations in Aberdeen, Sai Wan, Tin Hau, Chai Wan, Siu Sai Wan, Mong Kok, Hung Hom, Lai Chi Kok and San Po Kong. In N Out Storage’s sales has surged over 80% despite the pandamic and has grown to provide over 2500 storage units comprising of more than 150,000 square feet of property space across the City.

Addressing the booming demand of fine wine storage, In N Out Storage has newly revamped its facilities to cater wine collectors’ need through dedicated wine storage. Facilities are safeguarded with state of the art facial recognition security technology alongside stringent temperature and humidity control,

“Self-storage is a competitive business by nature. We have to be strategic in selecting expansion location .” said Jun Jun Lau, founder of In N Out Storage. ” We believe self-storage is not just a business but also a value-added service that would help the community to ease the shortage of living space. We continue to be optimistic in the growth of the sector and will continue to invest our resources into opening new stores and locations.”

Founded in 2015, In N Out Storage provides a variety of professional storage services, specializing in self-storage, wine storage, document storage and mailbox services. The Company aims to expand its storage network to better serve customers in Kowloon and New Territories in the near future.

Hashtag: #InNOutStorage

The issuer is solely responsible for the content of this announcement.

Johannesburg Gets Ready For Healthcare Innovation Summit Africa 2022

JOHANNESBURG, GAUTENG, ZA – Media OutReach – 9 November 2022 – It is that time of the year again, when healthcare professionals, industry experts and leaders gather to discuss the impact of emerging technologies on their industry. Taking place at Emperors Palace in Johannesburg on 16-17 November 2022 under the theme “Accelerating Digital Transformation in Healthcare: From Crisis to Opportunity”, the 7th Healthcare Innovation Summit Africa will attract hundreds of hospital CxOs, medical practitioners, healthcare IT leaders, service providers and government functionaries, as well as a carefully selected roster of local and international speakers.

#HISA2022 aims to address the many healthcare challenges that still exist in Africa, and critically assess the ways in which emerging technology trends such as AI, IoMT, EHR, 3D printing, Big Data Analytics, AR & VR, Wearables and Blockchain can improve healthcare.

This year’s Healthcare Innovation Summit Africa plans to tackle clinical and systemic challenges facing African healthcare and offer real-world technology solutions. Industry experts will share how the adoption of emerging technologies is making things easier for both health professionals and patients while also highlighting healthcare success stories and global best practices.

Why attend:
1.Learn about the latest innovative solutions in the healthcare sector.
2.Hear from Health-Tech entrepreneurs and policy makers from across the continent.
3.Explore developments in the use of technology in the healthcare sector.
4.Hear from successful organizations that have implemented game-changing health-tech solutions.
5.Enjoy an unparalleled networking platform and secure new opportunities and partners.

Confirmed speakers include:

  • Chevon Clark- CEO, National Renal Care.
  • Crystal Serena Vulavu- Council Member, Nairobi Division, Kenya Medical Association.
  • Denis Lafitte- CIO, King’s College Hospital NHS Foundation Trust.
  • Dr Rajeev Rao Eashwari- Director: ehealth Hospital Services, Gauteng Department of Health.
  • Fred Mumo- Head of Information Technology Services, AAR Hospital.
  • Jason McArthur- Managing Director HealthWare, Medical Technology.
  • Ulysse Baguida- CEO and Co-Founder, U’HOPE Company (Brussels- Belgium)
  • Thoneshan Naidoo- Principal Officer, Medshield Medical Scheme.
  • Jonathan Keytel- Head, Healthcare Transformation And Sustainability South Africa & Management Center Sub-Saharan Africa: Roche Diagnostics.
  • Michael Hasselber- Chief Digital Health Officer, University of Rochester Medical Centre.
  • Patrick Woodard- Chief Digital Officer, Methodist Le Bonheur Healthcare.
  • Saul Behrmann- Chief Operating Officer, Medi Response.
  • Teshlin Akaloo- Managing Director, Netcareplus

See More Speakers: HISA2022-Speakers

Key topics at this #HISA2022 include:

  • The future of healthcare.
  • Trends in healthcare funding & innovation.
  • Improving healthcare with AI.
  • Connecting Care Teams and Patients: Towards effective integrated care.
  • Enhancing the patient experience with data analytics.
  • Healthcare future funding & crisis response.
  • Effective integrated care and care continuity.
  • Unlocking insights to enable data-driven, digitally-enhanced healthcare.

How to Participate:

  1. Join as an attendee: Join local and international hospital CxOs, medical practitioners, healthcare IT leaders, service providers and government functionaries – for two days of top-level content, case studies, live demos, breakaway sessions and plenty of networking opportunities.
  1. Join as a speaker: Showcase your thought-leadership. Share your insights and experience. Shape solutions to critical business challenges.
  1. Join us as an exhibitor: Showcase your health-tech innovations, projects, and solutions. Put your organisation at the centre of this one-of-a-kind gathering. Find new partnerships, investors, leads, and opportunities.

For more information about this conference, visit: http://www.healthcareinnovationsummit.co.za/

Hashtag: #HealthcareInnovationSummitAfrica2022

European Chamber of Commerce and Industry Celebrates its 10th Anniversary

The European Chamber of Commerce and Industry in Laos celebrated its 10th anniversary with a spectacular gala dinner and Venetian ball.

DEUTZ AG: DEUTZ completes a successful nine-month period and publishes full-year guidance for 2022

  • Orders on hand rise to around €830 million
  • Revenue increases by 19 percent to almost €1.4 billion
  • Adjusted EBIT margin improves to 4.7 percent

COLOGNE, GERMANY – EQS Newswire – 9 November 2022 – Following a successful first half of the year, DEUTZ continued to generate growth and recorded double-digit increases in unit sales and revenue in the nine-month period. The war in Ukraine did not have a material adverse effect on business performance. However, as for other companies, the impact of the war on energy and raw material prices and on the global flow of goods around the world is very tangible for DEUTZ.

“Exceptionally high price increases across the board, combined with disruptions to supply chains, are taking their toll on the economy as a whole. Nonetheless, we raised our adjusted EBIT margin by 2.1 percentage points to 4.7 percent. This is proof positive that the performance initiatives that we have launched and our greater focus on maintaining cost discipline are increasingly paying off. This uptrend is encouraging but offers no room for complacency because we still have a long way to go before we achieve our targeted profitability level,” says CEO Dr. Sebastian C. Schulte. DEUTZ defined a range of measures under its Powering Progress strategy program that are aimed at facilitating the Company’s transition to alternative drive systems and new business models and boosting its commercial performance. They include passing on higher costs to customers in the short term through multiple rounds of price rises. This will increasingly mitigate the impact of these higher costs.

Looking to the future, Schulte adds: “Our orders on hand stood at the very high level of approximately €830 million at the end of September. That provides a stable starting position for the coming months. Market demand remains particularly strong for engines with a capacity of less than four liters. At the same time, our book-to-bill ratio of 0.95 in the third quarter indicates that market growth is gradually slowing down. However, we have set a course that will make DEUTZ more resilient in periods of economic weakness.”

As well as delivering a positive operating performance and successfully launching its first performance initiatives, DEUTZ made further progress with implementing its hydrogen strategy and joined the HyCET (Hydrogen Combustion Engine Trucks) research project consortium. HyCET aims to demonstrate the sustainability potential of trucks with hydrogen combustion engines in transportation logistics. As part of the project, two 18-tonne trucks will be developed and fitted with DEUTZ TCG 7.8 H2 hydrogen engines. The trucks will then be put through their paces by using them in the regular logistics operations of the BMW Group and DEUTZ. The four-year research project has a total investment volume of €19.5 million, of which €11.3 million will be funded by the German Federal Ministry for Digital and Transport (BMDV).

Furthermore, the Supervisory Board of DEUTZ AG has completed the reorganization of the Board of Management: Dr.-Ing. Petra Mayer took up her post as the new Chief Operating Officer (COO) at the start of November, while Timo Krutoff will join the Board of Management as the new CFO and Labor Director on December 1.

New orders close to the prior-year level, sharp rise in unit sales and revenue

In the first three quarters of 2022, new orders received by the DEUTZ Group amounted to €1,519.7 million. This was around the same high level of €1,514.0 million achieved in the prior-year period, which had been boosted by one-off effects of spending brought forward in an amount of more than €100 million.

The regional situation was mixed, with new orders rising markedly in the Americas and Asia-Pacific regions but declining slightly in the EMEA region during the reporting period. The application segments also presented a disparate picture. Whereas Material Handling, Agricultural Machinery, Stationary Equipment, and the service business generated increases in new orders (with some of them reporting double-digit percentage growth), there were significant year-on-year decreases for Construction Equipment and Miscellaneous.

Orders on hand continued to climb, advancing by 13.4 percent to reach a substantial €828.8 million as at September 30, 2022 (September 30, 2021: €616.4 million). This points to a stable order situation in the months ahead. Of that total, orders on hand attributable to the service business rose by 62.7 percent to €53.2 million (September 30, 2021: €32.7 million).

With a total of 169,352 units sold, the DEUTZ Group registered an increase in unit sales of 16.5 percent in the reporting period. Within this total, the number of DEUTZ engines[1] sold rose by 12.6 percent to 130,875. The DEUTZ subsidiary Torqeedo sold 38,477 electric boat drives, which was 32.3 percent more than in the prior-year period.

The uptrend in unit sales was generated across all application segments. The region with the sharpest increase was the Americas, where the rise of 48.5 percent was primarily attributable to higher unit sales of electric boat drives. The EMEA region, which is DEUTZ’s largest sales market, saw its unit sales climb by 10.8 percent.

Reflecting the growth in unit sales, DEUTZ’s revenue swelled by 19.0 percent to €1,395.8 million in the period under review. All regions and all of the main application segments recorded increases in revenue. The revenue of the service business grew to €336.2 million, accounting for around 25 percent of consolidated revenue. Within this business, parts sales and DEUTZ Xchange performed particularly well.

Strong improvement in profitability

EBIT before exceptional items (adjusted EBIT) improved from €30.9 million to €65.9 million in the period under review and thereby more than doubled. This improvement was attributable to the growth in the volume of business, the associated economies of scale, cost-saving measures, and positive currency effects. Moreover, the impact of additional costs stemming from persistent supply bottlenecks and higher materials prices is being increasingly mitigated thanks to these costs being passed on to our customers through price increases. The growth of research and development expenditure, higher procurement costs, and the losses generated by the DEUTZ subsidiary Torqeedo were more than offset by the aforementioned earnings drivers. The adjusted EBIT margin also increased significantly year on year, rising from 2.6 percent to 4.7 percent. In the high-revenue Classic segment, which encompasses all activities related to the development, production, distribution, and maintenance of diesel and gas engines as well as the related service business, the adjusted EBIT margin improved from 4.0 percent to 6.9 percent. As expected, the adjusted EBIT margin of the Green segment, which includes not only the DEUTZ subsidiary Torqeedo but also all activities related to new drives (such as hydrogen engines), decreased on the back of high levels of capital expenditure on research and development, falling to minus 51 percent.

The increase in adjusted EBIT meant that net income before exceptional items improved by 94.8 percent to €52.2 million in the reporting period, resulting in earnings per share before exceptional items of €0.43 (Q1–Q3 2021: €0.22).

Financial position remains comfortable

Cash flow from operating activities amounted to a net cash outflow of €13.8 million in the first nine months of 2022, compared with a net cash inflow of €67.9 million in the prior-year period. This decline was largely attributable to the rise in working capital. The growth in the volume of business and delays in the supply chain led to a rise in inventories, especially finished goods and work in progress. Moreover, the procurement of certain items in the market was extremely challenging, which resulted in a build-up of inventories of materials and components in order to safeguard production. The growth of inventories was only partly offset by the net cash inflow resulting from higher trade payables.

As a result of the decrease in cash flow from operating activities, free cash flow amounted to minus €69.8 million. This equated to a deterioration of €85.0 million compared with the first three quarters of 2021.

The equity ratio stood at 42.6 percent, compared with 45.6 percent at the end of 2021. The DEUTZ Group’s financial position therefore remains comfortable.

Full-year guidance for 2022 published

Given the considerable geopolitical uncertainties, DEUTZ stated that the guidance for 2022 published in its 2021 annual report was under review.[2] Based on its business performance in the first to third quarter, DEUTZ is now forecasting unit sales of between 175,000 and 185,000 DEUTZ engines[3] for 2022. This should result in an increase in revenue to between €1.75 billion and €1.85 billion. The adjusted EBIT margin is likely to be in a range of 4.5 percent to 5.0 percent. Despite this encouraging earnings guidance, free cash flow is expected to be a negative amount in the low- to mid-double-digit millions of euros. The main reasons for this are the build-up of inventories in order to safeguard production and delays in the supply chain.

DEUTZ Group: Overview of key figures

€ million Q1-Q3
2022
Q1-Q3
2021
Change
Q3
2022
Q3
2021
Change
New orders 1,519.7 1,514.0 0.4% 442.1 485.2 -8.9%
Group unit sales (units) 169,352 145,359 16.5% 60,611 51,732 17.2%
thereof DEUTZ engines[4] 130,875 116,273 12.6% 40,413 40,842 -1.1%
thereof Torqeedo 38,477 29,086 32.3% 20,198 10,890 85.5%
Revenue 1,395.8 1,173.4 19.0% 465.4 403.2 15.4%
EBIT 57.4 27.8 106.5% 21.9 11.7 87.2%
thereof exceptional items -8.5 -3.1 174.2% -1.4 -2.4 -41.7%
Adjusted EBIT (EBIT before exceptional items) 65.9 30.9 113.3% 23.3 14.1 65.2%
EBIT margin (%) 4.1 2.4 +1.7pp 4.7 2.9 +1.8pp
EBIT margin before exceptional items (%) 4.7 2.6 +2.1pp 5.0 3.5 +1.5pp
Net income 45.1 23.7 90.3% 17.1 10.4 64.4%
Net income before exceptional items 52.2 26.8 94.8% 18.2 12.8 42.2%
Earnings per share (€) 0.37 0.20 85.0% 0.14 0.09 55.6%
Earnings per share before exceptional items (€) 0.43 0.22 95.5% 0.15 0.10 50.0%
Equity (Sep. 30/Dec. 31) 642.9 588.4 9.3%
Equity ratio (%) 42.6 45.6 -3.0pp
Cash flow from operating activities -13.8 67.9 -28.4 23.2
Free cash flow -69.8 15.2 -45.1 5.5
Net financial position
(Sep. 30/Dec. 31)
-217.7 -79.7 -173.1%
Employees[5] (Sep. 30) 4,995 4,701 6.3%

The quarterly statement for the first to third quarter of 2022 is available on our website at www.deutz.com/en/investor-relations.

Forward-looking statements

This press release may contain certain forward-looking statements based on current assumptions and forecasts made by the DEUTZ management team. Various known and unknown risks, uncertainties, and other factors may lead to material differences between the actual results, the financial position, or the performance of the DEUTZ Group and the estimates and assessments set out here. These factors include those that DEUTZ has described in published reports, which are available at www.deutz.com. The Company does not undertake to update these forward-looking statements or to change them to reflect future events or developments.

[1] Excluding electric boat drives from DEUTZ subsidiary Torqeedo.
[2] See the press release dated March 14, 2022.
[3] Excluding electric boat drives from DEUTZ subsidiary Torqeedo.
[4] Excluding electric boat drives from DEUTZ subsidiary Torqeedo.
[5] Number of employees expressed in FTEs (full-time equivalents); excluding temporary workers.

The issuer is solely responsible for the content of this announcement.