Month: September 2021

• The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and the sixth approved CAR-T product globally
• Currently the only approved CAR-T product that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designation
• May provide a best-in-class CAR-T therapy in China given its demonstration of high rates of durable disease response and low rates of CAR-T associated toxicities

SHANGHAI, Sept. 6, 2021 /PRNewswire/ — JW Therapeutics (HKEx: 2126), an innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (hereafter abbreviated as relma-cel, R&D code JWCAR029) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, and has released the drug registration certificate. Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally.

Relma-cel, JW Therapeutics’ first CAR-T product, was independently developed based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company) to meet the needs of the Chinese market. Currently, it is the only approved CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review (in r/r LBCL) and breakthrough therapy designations (in follicular lymphoma). To date, over 100 patients have been dosed with relma-cel in clinical studies, marking relma-cel a most studied anti-CD19 CAR-T product in China.

This approval is based on the results of a single-arm, multi-center, pivotal study (RELIANCE study) to evaluate the efficacy and safety of relma-cel in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. RELIANCE study results show that relma-cel demonstrated high rates of durable disease response and low rates of CAR-T associated toxicities, and may provide a best-in-class CAR-T therapy profile.

Professor Zhu Jun, the lead investigator of RELIANCE study, Chief of Internal Medicine Department and Lymphoma Department at Peking University Cancer Hospital, said, “The RELIANCE study is a registrational clinical study completed with high quality, and I’m very proud of that. Based on the outstanding efficacy and safety profiles it demonstrated in RELIANCE study, I believe that relma-cel will provide healthcare professionals in China with an additional treatment option and bring hope for long-term remission and even cure for lymphoma patients.”

Edward Hu, Vice Chairman and Global Chief Investment Officer at WuXi AppTec, said, “Congratulations to JW Therapeutics for the approval of its first product. WuXi AppTec will continue to enable more companies to deliver advanced therapies for patients globally. Cell and gene therapy is one of the most promising therapies for curing cancer. As the co-founder and investor of JW Therapeutics, we are very pleased to witness its development over the past five years and are fully confident that JW Therapeutics will continue to lead the development of cell immunotherapy in China, and to bring us closer to a cure for cancer.”

Lynelle Hoch, senior vice president, Global Cell Therapy Franchise Lead, Bristol Myers Squibb, said, “As a long-standing strategic partner of JW Therapeutics, we are pleased by our work together to advance the important science of cell therapy. Today’s news, building from our CAR T cell process platform from Juno Therapeutics, marks an important milestone for patients in China and in achieving our shared goal of innovating breakthroughs for patients with cancer.”

James Li, Co-founder, Chairman and CEO of JW Therapeutics, said, “We sincerely thank all the patients and investigators who have participated and contributed in the clinical studies of relma-cel. We’re also encouraged by the Chinese regulators for taking the lead in following the science and approving the NDA of the sixth CAR-T therapy on a global scale. JW is committed to serving every Chinese patient through continued technology innovation.”

Sources:

Zhu J, et al. Clinical Response of CD19 CAR-T Cells (relma-cel) in Adults with Heavily-Pre-Treated Relapsed/Refractory (r/r) Large B-Cell Lymphoma in China. ASH 2020. Abstracts 1186.

About Relmacabtagene Autoleucel Injection (trade name: Carteyva^®)

Relmacabtagene autoleucel injection (trade name: Carteyva^®) is an autologous anti-CD19 CAR-T cell immunotherapy products that was independently developed by JW Therapeutics based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). The first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm, multi-center, pivotal study to evaluate the efficacy and safety of relmacabtagene autoleucel injection (relma-cel) in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. At the time it was conducted, this study was the largest clinical study of CAR-T cell therapy in China under the Investigational New Drug (IND) pathway.

RELIANCE study enrolled 59 patients with r/r LBCL who had failed at least two lines of therapy, including a CD20 agent and anthracycline, and patients continue to be monitored for up to 2 years and beyond for long term outcomes. As of the June 17, 2020 data cut-off, the Best Overall Response Rate was 75.9% with a Best Complete Response Rate of 51.7% in 58 evaluable patients; of 59 treated patients, 5.1% and 3.4% of the patients experienced CRS and NT of Grade 3 or above, respectively. Rates for any severity grade CRS and NT were 47.5% and 20.3%, respectively.

About JW Therapeutics

JW Therapeutics (HKEx: 2126) is an innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Co-founded by Juno Therapeutics (a Bristol Myers Squibb company) and WuXi AppTec in 2016, JW Therapeutics is committed to becoming an innovation leader in cell immunotherapy. The company has built a top world-class platform for technology and product development in cell immunotherapy, as well as a promising product pipeline covering both hematologic malignancies and solid tumors, to bring the hope of a cure for Chinese and global patients, and to lead the healthy and standardized development of China’s cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.

Forward-Looking Statements

The forward-looking statements are based on the management’s expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.

SERI ISKANDAR, Malaysia, Sept. 6, 2021 /PRNewswire/ — Universiti Teknologi PETRONAS (UTP) is the top ranking private university in Malaysia according to the Times Higher Education (THE) World University Rankings 2022 release, and successfully placed as second among Malaysian universities. In the latest rankings, the university has improved its position across three metrics, namely citations, research and international outlook.

For the first time, UTP has broken into the 501-600 band, rising from its previous band of 601-800. This is by far the university’s highest achievement since its debut in 2017.

“This achievement is one of the testaments that UTP is very determined in delivering its commitment towards all our stakeholders especially our parent company PETRONAS, students, parents, sponsors and collaborators.

“UTP will continue its significant momentum as a leading university among our international peers by re-engineering our research strategic focus resulting in better impact on publications, by producing niche and value adding commercial applications and by converging more strategic partnerships with universities and industries within the region. As part of the PETRONAS group, we also see significant opportunities by aligning our initiatives to support PETRONAS’ current and future businesses as well as its sustainability agenda. We hope this will elevate our business outlook and strengthen our financial sustainability which will be crucial for the university’s future,” said UTP Vice Chancellor, Professor Ts. Dr Mohamed Ibrahim Abdul Mutalib.

“I wish to thank PETRONAS for the strong and unwavering support and to my team for their continuous dedication, hard work and perseverance which have taken us this far. Also, to the UTP community, namely our students and parents, for being with us in this journey through thick and thin,” he added.

UTP has continuously cemented its position as the best private university in the country, proven through consistently being ranked in the world and the nation rankings and ratings such as THE, Quacquarelli Symonds (QS), Malaysia Research Assessment Rating System (MyRA) and Rating System for Malaysian Higher Education (SETARA).

Notably, in the THE Asia University Rankings 2021, UTP is ranked 111^th while for THE Young University Rankings 2021, the university is positioned at 134^th. Meanwhile for QS, UTP is ranked 70^th in the QS Asia University Rankings 2021. It is also ranked 230^th in the QS World University Rankings by Subject 2021, where both its Petroleum Engineering and Mineral Engineering subjects are ranked in the Top 50 and the first in the nation. Furthermore, UTP has retained its six-star rating (the highest performance level) in MyRA for its research development and commercialisation programme. In addition, the university has achieved a six-star or outstanding status in SETARA for its teaching, research and services.

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LONDON, Sept. 6, 2021 /PRNewswire/ — Over the last few weeks, London headquartered legal firm CS Global Partners has reported a significant increase in Pakistanis enquiring about attaining second citizenship through investment. The developments came as the country saw several acts of violence against women in a matter of weeks. The most recent incident involved an attack on a young woman at a national monument in Lahore on August 14.

Although Pakistan has seen progress in establishing peace within its borders, according to the Global Peace Index of 2021, the country still ranks 150 out of 163 countries in the world for its safety. Currently, parts of the country continue to face additional threats of terrorism, theft and political corruption.

Micha Emmett, the CEO of CS Global Partners, says that having access to physical and financial security is one of the top priorities for Pakistani clients. “Most citizens of Pakistan we speak to want second citizenship as a means to give their children a brighter, safer future. Citizenship from a country like St Kitts and Nevis can also open doors for their kids to choose from some of the best universities in the world without worrying about visitation visas and paperwork,” said Emmett.

St Kitts and Nevis has the longest-running Citizenship by Investment (CBI) Programme in the world. The Caribbean nation is surrounded by beautiful white sand beaches and acres of untouched nature and according to Emmett, is also a top choice for Pakistanis. The country allows vetted investors from Pakistan to become citizens from the comfort of their homes in a matter of months.

Under a limited-time offer that expires at the end of 2021, families of four get a USD45,000 price reduction from the Sustainable Growth Fund route. This option is praised for holding the fastest citizenship timeline by the PWM Magazine’s CBI Index. The report also noted St Kitts and Nevis’ robust due diligence process and family inclusivity for its ranking as the best CBI programme of 2021.

After successful applicants receive their Certificate of Citizenship, they can then apply for a passport with which visa-free and visa-on-arrival travel to nearly 160 countries and territories becomes a reality. “A second citizenship, a luxury that used to be reserved for the select few, has now become a necessity for many in this rapidly globalised world,” added Emmett.

Contact:
pr@csglobalpartners.com
www.csglobalpartners.com

BEIJING, Sept. 6, 2021 /PRNewswire/ — Private traffic has become a hot topic in the mobile internet sector over the past few years and is increasingly becoming an essential means of marketing with a number of advantages, including the ability to leverage a direct-to-consumer model, reusability, cost-effectiveness and lower operating costs.

Joy Spreader Group Inc. (hereafter referred to as the “Group”), a leading Chinese technology company mainly engaged in the mobile new media performance-based marketing business, announced its interim financial report for the first six months ended June 30, 2021 on August 30. According to the report, the Group plans to build private traffic by creating private-traffic-applied content across multiple channels in order to enhance its customer service capabilities and profitability.

Joy Spreader plans to provide tailor-made new media content for corporate customers’ VIP products by helping create new media accounts and private-traffic-applied content to build traffic through strategic alliances, investments and incubation projects. The aim is to further boost sales for customers by facilitating conversions of marketing points.

The interim financial report also showed that Joy Spreader achieved revenue of HK$624 million (approx. US$79.8 million) during the first half of 2021, an increase of 62.37 per cent from the same period of the previous year. Net profit excluding foreign exchange gains or losses for the period also grew 102.26 per cent year on year to HK$137 million (approx. US$17.5 million). The rapid growth in both revenue and net profit was directly associated with the Group’s massive traffic pools. As of June 30, 2021, the number of covered marketing points included in the marketing ecosystem of the Group totaled 1,561,601, up 208.65 per cent from the same period of 2020. In particular, the number of the firm’s marketing points on Douyin increased 720.23 per cent to 657,344 while that on the WeChat Public Account Platform surged 105.01 per cent to 872,923.

Currently, Joy Spreader offers access to marketing points on mobile new media platforms mainly via a third party. Through a partnership with the multi-channel network Beijing Yingyi Vision Technology, the Group found that content creators that have formed close relationships with the company can provide tailor-made content for the VIP products in its product inventories, helping the company increase sales by facilitating marketing point conversions.

Building private traffic doesn’t necessarily require Joy Spreader to switching the main way of its accessing path from third-party to private. The Group will continue to use third-party access as the main model for Supply-side Platform (SSP) services in an effort to rapidly provide services through its massive covered marketing points, with the aim of increasing sales of products by facilitating conversions. In addition, third-party access is a model that is easier to use, more standardized and highly replicable. The Group believes it is more efficient to build up the private traffic with more available VIP products in SKU which requiring professional and customized content.

Joy Spreader is seeking to increase private traffic that provides the quickest possible response among its traffic pools by creating more private-traffic-applied content. The growth of traffic pools is expected to further enhance the firm’s profitability, by expanding its mobile new media-based marketing business, including e-commerce and interactive entertainment.

For more information about Joy Spreader, please visit the company’s official website.