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Aurisco gets Auxiton® (Dydrogesterone) as first generic approval in China

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SHANGHAI, June 27, 2023 /PRNewswire/ — Aurisco Pharmaceutical has good reasons to celebrate. On its 25th anniversary, the high-tech pharmaceutical company dedicated to innovation has received its first Marketing Authorization Approval in China for AUXITON®, the oral finished dosage form of Dydrogesterone, from China’s Health Authority, the NMPA. Aurisco is the only company holding both an active USDMF and a valid CEP – the Certificate of compliance with the European Pharmacopoeia, issued by the EDQM for the drug substance.

 

 

Aurisco’s Chairman and founder, Mr. Peng Zhien, said: “After getting listed at the Shanghai Stock Exchange in 2020, this approval is another very important milestone for Aurisco. However, this is even more important for women with certain medical conditions that prevent them from having a healthy and successful pregnancy. These patients were the driving force for Aurisco to integrate the manufacturing of the active pharmaceutical ingredient with the development and manufacturing of the oral tablet finished dosage form. We hope to contribute to the happiness of many couples, by making possible their dream of having a baby.”

As explained by Vivian Shan, MD, Aurisco Pharmaceutical’s Medical Manager for this program, “AUXITON® provides doctors a safe and convenient, orally bioavailable dydrogesterone – a highly selective progestogen receptor agonist. With an equivalence dose 10–20 times lower than progesterone due to its better bioavailability and the progestogenic nature of the metabolites, dydrogesterone has multiple advantages over natural progesterone, ensuring efficacy and safety to establish the adequate levels for luteal support during natural pregnancy and in-vitro fertilization (IVF).”

“Since its foundation, Aurisco has been developing complex generic molecules, including steroids like dydrogesterone and more recently peptides like semaglutide or oligonucleotides such as nusinersen. Integrating the production of API, formulation and finished dosage, Aurisco ensures product quality, productivity, and cost advantages throughout the entire industrial chain, to guarantee adequate productivity and stable supply to meet new clinical programs. Following international cGMP and EHS standards, our product quality is in line with China, Europe, and United States standards. We have been working with the best generic pharmaceutical companies in the world, supplying them safe, sustainable, affordable and high-quality products. Leveraging on our technologically advanced and differentiated capabilities, we also work with innovators, offering contract research, development and manufacturing services (CRDMO),” says Alessandro Ricci, President of Aurisco USA, based in New York.

Rafael Antunes, Aurisco’s Vice-President for Business Development in Europe, stated: “The company has always been a pioneer in the API space. We were the first company in China to develop the phytosterol technology or to pass a RX360 supply-chain security audit. Being Ecovadis ranked, we have embraced ESG and Sustainability, by joining the Science Based Targets initiative (SBTi), the Manufacture 2030 and Energize initiatives to decarbonize the pharmaceutical supply-chain and adopt renewable energies, just to mention a few. We are based in China but export to over 100 countries, so we have a global responsibility.”

“The development and manufacturing of AUXITON® is a good example of some of our technical capabilities. As a science-based company, we have developed recombinant strains for fermentation, we produce and use selective enzymes for biocatalysis and chiral catalysts for asymmetric hydrogenation or industrial-scale photochemistry to make processes more sustainable and economical. Our dydrogesterone is produced with very low impurity levels, with consistent pharmacokinetic and human bioequivalence profiles when compared with the originator, essential prerequisites for clinical efficacy and safety. We are fast, very innovative and work with the best Universities to attract and retain top talent in the company. Aurisco has filled over 80 patents worldwide and offer customers the confidence of a IP-safe partner in China,” said Prof. Li Jinliang, CEO of Aurisco’s Biotech subsidiary, in Shanghai.

To learn more about Aurisco Pharmaceutical and its products and CRDMO services, please contact [email protected].

About Dydrogesterone

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Dydrogesterone is a potent orally active progesterone receptor agonist that was developed in the 1950s and that has been widely used since the 1960s for menstrual disorders such as premenstrual syndrome, cycle irregularity, endometriosis, threatened miscarriage, and habitual miscarriage, and for postmenopausal hormone therapy. It is estimated that the cumulative exposure for all indications from 1960–2017 is >113 million patients.

About Aurisco Pharmaceutical

Aurisco Pharmaceutical is a listed company on the Shanghai Stock Exchange (Stock code: 605116). With 25 years of experience in the development and manufacturing of complex APIs for regulated markets and with 6 R&D centers and 3 cGMP inspected manufacturing sites, it is focused on semi-synthetic and synthetic APIs, including steroids, peptides and oligonucleotides and hormone-based finished dosage forms, offering CRDMO services to the Global Pharmaceutical Industry.

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Media contact: 
Rafael Antunes 
[email protected]
+351 919 387 143

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China’s AIMA brand electric motorbike is now in Bangladesh

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DHAKA, Bangladesh, Nov. 23, 2024 /PRNewswire/ — With the popularity of electric vehicles in Bangladesh, the globally renowned AIMA brand has also arrived in Bangladesh. The esteemed DX Group has brought the AIMA F-626 to customers. This environmentally friendly battery-operated electric motorbike has already been approved by the Bangladesh Road Transport Authority (BRTA) now. 

In light of the increasing popularity of electric motorcycles in the country, the internationally-leading brand AIMA has entered the market. By the end of 2023, AIMA electric two-wheelers had established a presence in over 50 countries worldwide, with 11 global production bases, including overseas factories in Indonesia and Vietnam. In 2022, AIMA collaborated with Rob Janoff, the designer of the Apple logo, to refresh the brand’s VI system with a youthful and fashionable image. In 2023, AIMA teamed up with PANTONE, the global authority in color expertise, to create the trending color of the year. As an industry leader, AIMA spearheads the electric two-wheeler sector and showcases the prowess of a leading electric two-wheeler brand on a global scale. As of March 31, 2024, AIMA’s total electric two-wheeler sales had reached 80 million units, earning certification from Frost & Sullivan, a globally recognized business growth consulting firm, as the “Global Leading Electric Two-wheeler Brand”.

Over the years, AIMA has always been a product trendsetter in the electric two-wheeler sector. As of March 31, 2024, the total sales volume of AIMA electric two-wheelers reached 80 million, and Frost & Sullivan, a world-renowned market consulting company, awarded AIMA with the market status certification of the “Global Leading Electric Two-wheeler Brand (by Sales)”.

AIMA adhere to the customer-centered product philosophy and technologies that support long-term innovation and breakthroughs. We believe that the efficiency and modern technology of the AIMA F-626 will present an excellent alternative means of communication for our customers.

 

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China Telecom Gulf Officially Launches in Saudi Arabia for Business

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HONG KONG, Nov. 23, 2024 /PRNewswire/ — On November 21, China Telecom Gulf was officially launched in Riyadh. This milestone marks a significant step in China Telecom’s efforts to provide deep services under the “Belt and Road Initiative” and to promote the building of a “China-Arab Community with a Shared Future.” It signifies another solid advancement on China Telecom’s path toward internationalization. Mr. Liu Guiqing, Executive Director and EVP of China Telecom Corporation, delivered an opening speech, along with Mr. Fawaz, Representative of Contact Office of Chinese Companies in the KSA, Deputy General Manager of Industrial and Commercial Bank of China Riyadh Branch. Over 100 guests and leaders from the Economic and Commercial Office of Embassy of the PRC of the KSA, Saudi Telecom Company (STC), Bank of China, Huawei, and others attended to witness this momentous occasion.

In his address, Mr. Liu Guiqing emphasized China Telecom’s commitment to openness, cooperation, and mutual benefit. He expressed the company’s willingness to share its experiences in cloud-network integration, cloud transformation, intelligent operations, and technological innovation. China Telecom aims to work closely with various levels of Saudi governments, enterprises, and partners to actively participate in the development of local digital infrastructure, drive the rapid advancement of next-generation information technologies, and establish a robust bridge for cooperation between China and Saudi Arabia in the field of information technology. Leveraging its extensive resources and global operational capabilities, China Telecom plans to bring its strengths in 5G, cloud computing, artificial intelligence, and other fields to provide innovative, high-quality communication products and services to Saudi enterprises, institutions, and consumers.

Mr. Fawaz extended his warm congratulations on the opening of China Telecom Gulf. He highlighted that as a leading global provider of communication services, China Telecom possesses abundant cloud-network resources and mature international service capabilities. The establishment of China Telecom Gulf is a significant step toward supporting the digital transformation of businesses in the region. He expressed confidence that through joint efforts, the company will seize opportunities in the digital era and contribute to Saudi Arabia’s socio-economic development and practical cooperation between China and Saudi Arabia in various fields.

China Telecom showcased its global resources, business capabilities, and its investments and partnerships in the Middle East and Africa. Key services introduced included eSurfing Cloud, computing power solutions, quantum technology, and customized 5G networks. Currently, China Telecom operates branches in 42 countries and regions worldwide, owns 53 international submarine cables, and manages 27 self-operated Internet Data Centers (IDCs). Its cloud-network integrated infrastructure and customer-centric digital service systems provide coverage across the globe.

During the event, China Telecom Gulf signed strategic cooperation agreements with Saudi Telecom Company (STC), Huawei Saudi Arabia, and Baud Telecom Company. The parties committed to deep collaboration, leveraging their respective strengths to provide optimized and convenient digital experiences to Saudi customers.

The establishment of China Telecom’s presence in Saudi Arabia marks a major milestone in the company’s entry into the Middle Eastern communications market, representing a key development in its global strategy. Moving forward, China Telecom Gulf will leverage China Telecom’s robust digital infrastructure and resource integration capabilities. We will collaborate closely with local Saudi enterprises, Chinese businesses expanding internationally, and global companies to strengthen cooperation and enhance exchanges. The company aims to contribute to the growth of Sino-Saudi and Middle Eastern industrial cooperation, continuously offering more smart solutions for the development of the Middle East’s digital economy, while striving to become a world-class provider of digital and intelligent technology services.

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Redefining Financial Frontiers: Nucleus Software Celebrates 30 Years with Synapse 2024 in Singapore

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SINGAPORE, Nov. 23, 2024 /PRNewswire/ — The thriving IndiaSingapore partnership in banking and technology reached a new milestone as Nucleus Software celebrated 30 years of transformative innovation at Synapse 2024, held in Singapore. The event underscored the company’s role in redefining financial services across Southeast Asia (SEA) and the globe, bringing together leaders in finance and technology to explore a shared vision for the future of banking.

Synapse 2024 celebrated 30 years of Nucleus Software’s leadership in driving transformative change across Singapore and Southeast Asia’s financial ecosystem. The event also shone a spotlight on the Global Finance & Technology Network (GFTN), an initiative supported by the Monetary Authority of Singapore (MAS) to champion responsible technology adoption. The event highlighted the deepening synergies between India and Singapore, driven by their shared commitment to innovation, cross-border collaboration, and financial inclusion. As the financial services sector undergoes rapid evolution with advancements in artificial intelligence, blockchain, and digital banking, these partnerships are setting the stage for a more connected, resilient, and inclusive global ecosystem.

Vishnu R. Dusad, Co-founder and Managing Director of Nucleus Software, reflected on the milestone: “For over 30 years, we’ve had the privilege of aligning our journey with Singapore’s ascent as a global financial powerhouse. Back in 1994, when we chose to go East instead of West, it was a bold and emotional decision—guided by our belief in Singapore as a hub for innovation and collaboration. We saw then what remains true today: Singapore is at the heart of the global financial landscape, a place where new ideas take root, and partnerships thrive.”

The event brought together a distinguished array of participants, highlighting the transformative potential of IndiaSingapore collaboration. Mr. Piyush Gupta, CEO of DBS Group and the Guest of Honor, set the tone for the event with his opening remarks, emphasizing the transformative role of big tech in reimagining scalable, customer-centric financial services in the digital age.

Following his address, key speakers enriched the discussions with their insights. Mr. Sopnendu Mohanty, Chief Fintech Officer at the Monetary Authority of Singapore and Group CEO-Designate of The Global Finance & Technology Network (GFTN), underlined the importance of fostering responsible technology adoption and building inclusive financial ecosystems. Mr. Vinod Rai, globally respected public policy expert, Distinguished Visiting Research Fellow at the National University of Singapore, and former Comptroller and Auditor General of India, shared his perspectives on governance and policy frameworks in financial systems. Mr. S.M. Acharya, Chairman of Nucleus Software and former Defence Secretary of India, offered a visionary outlook on leveraging technology to modernize and secure banking frameworks. Finally, Mr. Pieter Franken, Co-founder and Director of GFTN (Japan), a global FinTech pioneer and deep tech innovator, discussed the future of decentralized finance and its implications for the financial sector.

The event showcased the transformative role of technology in global financial systems, emphasizing innovations that set benchmarks for scalability and inclusivity. Panelists discussed the importance of localized solutions, the challenges of cross-border integration, and leveraging dual business models to optimize capital and foster public participation. The dialogue highlighted the need for common standards, unified frameworks like APIs, and collaborative efforts to accelerate financial inclusion and drive global connectivity in the digital age.

For 30 years, Nucleus Software has consistently introduced advanced lending and banking solutions that support financial institutions’ evolving needs in Singapore and South East Asia. Driven by lean development methodologies like Acceptance Test-Driven Development (ATDD) and Continuous Integration/Continuous Delivery (CICD), Nucleus Software continues to push boundaries in efficient, flexible, and secure financial technology.

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