RELYBO PHARMACHEMICAL CO.,LTD.南京瑞恩医药有限公司

RELYBO PHARMACHEMICAL CO.,LTD. ("RELYBO" for short, while the word of RELYBO comes from "reliable" by a similar glyph and pronunciation) has always been focusing on the field of pharmaceuticals and chemicals, mainly engaged in APIs & Intermediates, Fine Chemicals, Basic Chemicals, Agrochemicals and Organic Solvents, etc.

Since its establishment in 2011, RELYBO has already been keeping stable development of business, while its products are exported to Europe, North America, Asia, Africa and Latin America, and RELYBO enjoys a good reputation at home and abroad. After years of unremitting efforts, RELYBO has established strategic cooperation with many well-known R&D institutions in China, and also established production bases of Organic Fluorine Chemistry and Organic Sulfur Chemistry Separately in Fuxin, Liaoning Province and Yangcheng, Shanxi Province. Thus, RELYBO has changed from a single trade-oriented company to a diversified comprehensive enterprise integrating R&D, production and trade.

RELYBO has an excellent team, which is professional, efficient and dynamic, while this team started in 2004. It is worth mentioning that RELYBO became a member enterprise of "DUDLEY CHEM" in 2019, which brought RELYBO to reorganize and establish some core divisions / departments such as Pharmaceutical Division, Chemical Division, Marketing Department and so on. Looking forward to greater development of RELYBO in the future!

Adhering to the business philosophy of "Development & Innovation, based on the Market; Honesty & Pragmatism, loyal to the Commitment" and with the mission of "Pursuing Customer Satisfaction and Creating Greater Value for Customers", RELYBO is always providing customers with high-quality products and first-class services!

Gilead Sciences agrees to buy Immunomedics in $21 billion deal

Gilead Sciences and Immunomedics have announced they have entered into a definitive agreement whereby Gilead will acquire Immunomedics for approximately $21 billion.

The agreement will provide Gilead with Trodelvy (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval by the FDA in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the US later this year. The company is also on track to file for regulatory approval in Europe in the first half of 2021.

In the Phase III ASCENT study, which was halted early due to efficacy based on the unanimous recommendation of the independent Data Safety Monitoring Committee, Trodelvy significantly improved progression-free survival and overall survival in previously treated patients with advanced mTNBC.

Beyond mTNBC, Trodelvy is also being studied in an ongoing Phase III trial in third line HR+/HER2- breast cancer and a registrational PhaseII study in bladder cancer. Additional ongoing studies are evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other solid tumor types.

“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments,” said Daniel O’Day, Chairman and CEO, Gilead Sciences.

From CPhI Online

Portuguese PM says AstraZeneca's vaccine-trial pause

LISBON, Sept. 9 (Xinhua) -- Portuguese Prime Minister Antonio Costa on Wednesday said it's "bad news" that British-Swedish pharmaceutical giant AstraZeneca decided to suspend trials of a COVID-19 vaccine candidate, local media reported.

AstraZeneca, which is developing a possible vaccine against COVID-19 in partnership with the University of Oxford, on Wednesday put on hold the phase-3 trial of its vaccine following an unexplained illness in one trial participant in Britain.

"Last week, there was enormous optimism that the process of advancing vaccines was fast. Today, we all wake up with bad news that at least one vaccine process had to be suspended. It is an uncertain factor," Antonio Costa told reporters during a visit to the Contemporary Textile Art Biennial in north Portugal.

"We don't know -- nobody knows -- when the pandemic ends, but we know that until there is a vaccine, it will not disappear," the prime minister was quoted by Portuguese Lusa news agency as saying.

At a virtual briefing on Aug. 6, Michael Ryan, executive director of the World Health Organization's Health Emergencies Program, said that six COVID-19 vaccine candidates had entered phase-3 trials.

Of the six vaccine candidates, three are from China -- made by Sinovac, Wuhan Institute of Biological Products/Sinopharm, and Beijing Institute of Biological Products/Sinopharm, said Ryan.

The other three are made by the University of Oxford/AstraZeneca, Moderna/NIAID, and BioNTech/Fosun Pharma/Pfizer, he added.

From Xinhua
Indian pharma company launches Remdesivir injection to treat COVID-19 patients

MUMBAI, Aug. 13 (Xinhua) -- India's Cadila Healthcare has launched Remdesivir lyophilized injection to treat COVID-19 patients, a company statement said Thursday.

The price was at 37.4 U.S. dollars for 100 mg vial.

In June, the Indian company entered into a non-exclusive agreement with U.S. bio-pharmaceutical company - Gilead Sciences Inc., to manufacture and sell Remdesivir, the investigational drug which has been issued an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) to treat patients suffering from severe symptoms of COVID-19.

The API (active pharma ingredient) for the drug has been developed and manufactured at the company's manufacturing facilities in India's western state of Gujarat.

"Through the course of this pandemic, our efforts have been focused on supporting people in this healthcare crisis, whether it is through developing vaccines, ramping up production and distribution of critical drugs and therapies, making diagnostic tests available or exploring new treatment options," said Sharvil Patel, managing director of Cadila Healthcare.

India is currently the third hardest-hit country by COVID-19, after the United States and Brazil. It has 653,622 active cases of novel coronavirus with 47,033 deaths reported so far.

From Xinhua
COVID-19 vaccine program boosts revenues of German pharmaceutical company BioNTech

Revenues from collaboration agreements went up because of new projects with U.S. company Pfizer and China's Fosun Pharma "as part of the company's BNT162 vaccine program against COVID-19," according to BioNTech.

BERLIN, Aug. 11 (Xinhua) -- Revenues of German pharmaceutical company BioNTech in the second quarter (Q2) of 2020 reached 41.8 million euros (49.3 million U.S. dollars), compared with 25.8 million euros in Q2 last year, the firm announced on Tuesday.

Revenues from collaboration agreements went up as well because of new projects with U.S. company Pfizer and China's Fosun Pharma "as part of the company's BNT162 vaccine program against COVID-19," according to BioNTech.

However, net loss increased to 88.3 million euros in Q2, compared to a net loss of only 50.1 million euros at the same time last year. At the end of the second quarter, the German company held cash and cash equivalents of 573 million euros.

"We made significant progress in the second quarter toward our goal of advancing our oncology programs and toward bringing a COVID-19 vaccine to market as quickly as possible," said Ugur Sahin, chief executive officer (CEO) and co-founder of BioNTech.

The German biopharmaceutical company and its U.S. partner Pfizer were planning to "file for market authorization or regulatory approval as early as October 2020" if the current clinical study on their potential COVID-19 vaccine was successful, BioNTech noted.

BioNTech's employees managed to initiate the trial for the COVID-19 vaccine program "in record time," added Sahin on Tuesday when presenting the company's Q2 figures.

At the end of July, a worldwide study on the potential vaccine had started with up to 30,000 participants. The clinical trial in phase II/III was intended to show, among other things, whether the ingredient BNT162b2 actually protects against infections with COVID-19.

In addition, a phase one study with vaccine candidate BNT162b1 started to "evaluate safety and immunogenicity in Chinese participants to support potential regulatory approval in China," according to BioNTech.

From Xinhua