Fintech PR
Aurisco gets Auxiton® (Dydrogesterone) as first generic approval in China
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
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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STOCKHOLM, April 5, 2024 /PRNewswire/ — EQT AB’s Q1 Announcement 2024 will be published on Thursday 18 April 2024 at approximately 07:30 CEST. EQT will host a conference call at 08:30 CEST to present the report, followed by a Q&A session.
The presentation and a video link for the webcast will be available here from the time of the publication of the Q1 Announcement.
To participate by phone and ask questions during the Q&A, please register here in advance. Upon registration, you will receive your personal dial-in details.
The webcast can be followed live here and a recording will be available afterwards.
Information on EQT AB’s financial reporting
The EQT AB Group has a long-term business model founded on a promise to its fund investors to invest capital, drive value creation and create consistent attractive returns over a 5 to 10-year horizon. The Group’s financial model is primarily affected by the size of its fee-generating assets under management, the performance of the EQT funds and its ability to recruit and retain top talent.
The Group operates in a market driven by long-term trends and thus believes quarterly financial statements are less relevant for investors. However, in order to provide the market with relevant and suitable information about the Group’s development, EQT publishes quarterly announcements with key operating numbers that are relevant for the business performance (taking Nasdaq’s guidance note for preparing interim management statements into consideration). In addition, a half-year report and a year-end report including financial statements and further information relevant for investors is published. Finally, EQT also publishes an annual report including sustainability reporting.
Contact
Olof Svensson, Head of Shareholder Relations, +46 72 989 09 15
EQT Shareholder Relations, [email protected]
Rickard Buch, Head of Corporate Communications, +46 72 989 09 11
EQT Press Office, [email protected], +46 8 506 55 334
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/eqt/r/invitation-to-presentation-of-eqt-ab-s-q1-announcement-2024,c3956826
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Invitation to presentation of EQT AB’s Q1 Announcement 2024 |
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EQT AB Group |
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- Kia drives forward transformation into ‘Sustainable Mobility Solutions Provider’
- Roadmap enables Kia to proactively respond to uncertainties in mobility industry landscape, including changes in EV market
- Company to expand EV line-up with more models; enhance HEV line-up to manage fluctuation in EV demand
- Goal to sell 1.6 million EVs annually in 2030, introducing 15 models
- PBV to play a key role in Kia’s growth, targeting 250,000 PBV sales annually by 2030 with PV5 and PV7 models
- Kia to invest KRW 38 trillion by 2028, including KRW 15 trillion for future business
- 2024 business guidance : KRW 101 tln in revenue with KRW 12 tln in operating profit; operating profit margin of 11.9% on sales of 3.2 million units globally
- CEO reaffirms Kia’s commitment to ESG management
SEOUL, South Korea, April 5, 2024 /PRNewswire/ — Kia Corporation (Kia) today shared an update on its future strategies and financial targets at its CEO Investor Day in Seoul, Korea.
Based on its innovative achievements in the years since the announcement of mid-to-long-term business initiatives, Kia is focusing on updating its 2030 strategy announced last year and further strengthening its business strategy in response to uncertainties across the global mobility industry landscape.
During the event, Kia updated its mid-to-long-term business strategy with a focus on electrification, and its PBV business. Kia reiterated its 2030 annual sales target of 4.3 million units, including 1.6 million units of electric vehicles (EVs). The 2030 4.3 million annual sales target is 34.4 percent higher than the brand’s 2024 annual goal of 3.2 million units.
The company also plans to become a leading EV brand by selling a higher percentage of electrified models among its total sales, including hybrid electric vehicles (HEV), plug-in hybrid (PHEV), and battery EVs, projecting electrified model sales of 2.48 million units annually or 58 percent of Kia’s total sales in 2030.
“Following our successful brand relaunch in 2021, Kia is enhancing its global business strategy to further the establishment of an innovative EV line-up and accelerate the company’s transition to a sustainable mobility solutions provider,” said Ho Sung Song, President and CEO of Kia. “By responding effectively to changes in the mobility market and efficiently implementing mid-to-long-term strategies, Kia is strengthening its brand commitment to the wellbeing of customers, communities, the global society, and the environment.”
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VANCOUVER, BC, April 4, 2024 /PRNewswire/ — BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (the “Company“) is providing this bi-weekly update on the status of the management cease trade order granted on February 29, 2024 (the “MCTO“), by its principal regulator, the Ontario Securities Commission (the “OSC“), under National Policy 12-203 – Management Cease Trade Orders (“NP 12-203“), following the Company’s announcement on February 21, 2024 (the “Default Announcement“), that it was unable to file its audited annual financial statements for the year ended October 31, 2023, its management’s discussion and analysis of financial statements for the year ended October 31, 2023, its annual information form for the year ended October 31, 2023, and related filings (collectively, the “Required Annual Filings“). Under National Instrument 51-102, the Required Annual Filings were required to be made no later than February 28, 2024.
As a result of the delay in filing the Required Annual Filings, the Company was unable to file its interim financial statements for the three months ended January 31, 2024, its management’s discussion and analysis of financial statements for the three months ended January 31, 2024, and related filings (collectively, the “Required Interim Filings“). Under National Instrument 51-102, the Required Interim Filings were required to be made no later than April 1, 2024.
The Company anticipates filing the Required Annual Filings by April 30, 2024. The auditor of the Company requires additional time to complete its audit of the Company, including the Company’s recent acquisition of all intellectual property, immunotherapeutics platform technologies, and clinical stage assets of the former IMV Inc. that closed on February 16, 2024. In addition, the Company anticipates filing the Required Interim Filings immediately after the filing of the Required Annual Filings.
Except as herein disclosed, there are no material changes to the information contained in the Default Announcement. In addition, (i) the Company is satisfying and confirms that it intends to continue to satisfy the provisions of the alternative information guidelines under NP 12-203 and issue bi-weekly default status reports for so long as the delay in filing the Required Annual Filings and/or Required Interim Filings is continuing, each of which will be issued in the form of a press release; (ii) the Company does not have any information at this time regarding any anticipated specified default subsequent to the default in filing the Required Annual Filings and Required Interim Filings; (iii) the Company is not subject to any insolvency proceedings; and (iv) there is no material information concerning the affairs of the Company that has not been generally disclosed.
About BioVaxys Technology Corp.
BioVaxys Technology Corp. (www.biovaxys.com), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it’s HapTenix© ‘neoantigen’ tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company’s clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© ‘neoantigen’ tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn.
ON BEHALF OF THE BOARD
Signed “James Passin“
James Passin, Chief Executive Officer
Phone: +1 646 452 7054
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