On September 6, 2021 JW Therapeutics (HKEx: 2126), an innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported 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 (Press release, JW Therapeutics, SEP 6, 2021, View Source [SID1234587276]). Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally.

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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 on

On September 6, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that the Company’s ordinary shares, which trade on The Stock Exchange of Hong Kong Limited ("HKEX"), are included in the Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect programs, effective on September 6, 2021, according to announcements issued by the Shanghai Stock Exchange and the Shenzhen Stock Exchange (Press release, Hutchison China MediTech, SEP 6, 2021, View Source [SID1234587383]).

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The Stock Connect programs allow international and Mainland Chinese investors to trade securities in each other’s markets through the trading and clearing facilities of HKEX, Shanghai and Shenzhen Stock Exchanges. Qualified Mainland Chinese investors can access eligible Hong Kong shares (Southbound), while Hong Kong and overseas investors can trade eligible A shares (Northbound), subject to specified daily quotas.

Christian Hogg, CEO of HUTCHMED commented: "We are pleased to be included in the Stock Connect programs and that qualified Mainland Chinese investors will now have direct access to our shares through the Shanghai and Shenzhen Stock Exchanges."

Hang Seng Indexes Company Limited announced on August 20, 2021, that HUTCHMED would be included as a constituent of several indexes including the Hang Seng Composite Index from September 6, 2021. Inclusion in the Hang Seng Composite Index is a key requirement for the Stock Connect scheme.

On September 5, 2021 Kintor Pharmaceutical Limited ("Kintor Pharma," HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, reported that the company’s stock has been included in the Hong Kong Stock Connect program (the "Hong Kong Stock Connect"), effective September 6, 2021 (Press release, Suzhou Kintor Pharmaceuticals, SEP 5, 2021, View Source [SID1234587262]).

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Dr. Youzhi Tong, Founder, Chairman, and Chief Executive Officer of Kintor Pharma, commented, "We are excited to be included in the Hong Kong Stock Connect. Since Kintor Pharma was officially listed on the Hong Kong Stock Exchange on May 22, 2020, the company’s development has received long-term support from investors. We expect that the inclusion in the Stock Connect program will facilitate further expansion of our investor base and enhance the liquidity of our stock. We continue to advance the progress of our research and development, clinical operations, and commercialization efforts to innovate therapeutics for patients with unmet medical needs, help advance human health, and maximize value for our shareholders."

On September 5, 2021 GeneQuantum Healthcare (Suzhou) Co.,Ltd. (hereinafter referred to as "GeneQuantum") and BrighGene Biomedical (Suzhou) Co.,Ltd. (hereinafter referred to as "BrighGene ") reported that it signed a co-development agreement for antibody immune agonist conjugate (AIAC), GQ1007 (Press release, GeneQuantum Healthcare, SEP 5, 2021, https://www.prnewswire.com/news-releases/genequantum-and-brighgene-sign-agreement-for-development-of-antibody-immune-agonist-conjugates-301369524.html [SID1234587263]).

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GQ1007 is a new type of antibody-drug conjugate. It is an antibody conjugated to a potent immune agonist. In recent years, immunotherapeutic antibody drugs targeting PD-1 and PD-L1 (representing immune checkpoint inhibitors) have revolutionized cancer therapy. Even though the superior efficacy of immune checkpoint inhibitor treatment has shown great benefit, many cancer patients do not respond to such treatment. These non-responsive tumors are referred to as "cold" tumors. Compared with other immunotherapies, such as anti-PD1 / PD-L1 and anti-CD40 etc., GQ1007 not only can precisely reach tumor site but also enhance innate and adaptive immune responses. It activates dendritic cells and macrophagesand increases T cell infiltration into tumor tissue through immune agonists, thus "cold" tumors becomes "hot" tumors and immune system is mobilized to suppress tumors. Ultimately, GQ 1007 achieves strong and lasting anti-tumor effect, overcomes the low response rate of PD-1 antibody in immunotherapy, and has great clinical value and market potential.

Dr. Paul Song, Chief Scientific Officer of GeneQuantum comments: "BrighGene has extensive experience in small molecule drug development, they hold a unique and competitive advantage in TLR7/8 agonists. We are incredibly pleased to work with R&D team led by Dr. Jiandong Yuan, CEO of BrightGene. By working together, we expect to achieve IND filing for GQ 1007 soon."

Dr. Gang Qin, Founder, Chairman and Chief Executive Officer comments: "Seamless integration of small molecule platform of BrighGene and iLDC technology platform of GeneQuantum will enhance our R&D capability for world competitive innovation conjugates, this collaboration fully demonstrate high effectivity of resource and expertise integration among China biomedical companies, which significantly improve new drug development. Based on our in-house iLDC technology, GeneQuantum continues to establish in-depth collaborations with domestic and international biopharmaceutical companies to develop more innovative drugs."

Dr. Jiandong Yuan, CEO of BrightGene, comments, "GeneQuantum’s enzymatic site-specific conjugation technology and unique linker technology effectively improve current issues of chemical conjugation, such as high heterogeneity, low stability, narrow treatment windowand difficult manufacturing challenges for ADC drug products. Linker stability is extremely important in the field of antibody immune agonist conjugates. GeneQuantum’s unique stable linker technology can decrease or even avoid random shedding of immune agonists in circulation and significantly reduce the likelihood of general (non-specific) immune activation, it ensures this AIAC molecule with best-in-class potential. BrighGene and GeneQuantum will keep close collaboration relationship, fully leverage our individual core strengths to develop more globally competitive first-in-class or best-in-class drugs in near future."

On September 5, 2021 AffaMed Therapeutics ("AffaMed"), a global clinical stage biopharmaceutical company dedicated to addressing critical unmet medical needs in ophthalmic, neurological and psychiatric disorders, reported that during the recent "China International Trade in Services Fair 2021" a strategic cooperation partnership with Beijing Tiantan Hospital of Capital Medical University ("Beijing Tiantan Hospital") and Beijing Infinite Brain Technologies ("IBT") (Press release, AffaMed Therapeutics, SEP 5, 2021, View Source [SID1234587264]). The three parties will cooperate to promote the application and development of digital therapy in neurological diseases.

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"Digital therapy offers new possibilities in the treatment of different diseases as a novel therapeutic approach and has demonstrated encouraging clinical performance in the fields of cognitive behavior, biofeedback and neural oscillations, as distinguished from the existing mobile health applications and remote diagnosis and treatment", said Dr. Dayao Zhao, CEO of AffaMed, "AffaMed focuses on neurological and psychiatric disorders, and is committed to continuing to discover innovative therapies. The Beijing Municipal Government recently published the ‘Action Plan for Accelerating Collaborative Innovation in Medicine and Health’, with the aim to advance the new digital medical industry and support the research and development of digital medical products targeting areas such as mental disease and neurodegenerative disorders. With this clear regulatory support, I believe our strong alliance with Tiantan Hospital and IBT will further drive technological research, clinical application and commercial development, and support our ambition to lead and accelerate the innovation and implementation of digital therapy in China."

Dr. Wang Yongjun, President of Beijing Tiantan Hospital said: "As the problem of aging population in society worsens, the prevalence of cerebrovascular diseases and cognitive impairment continues to increase yearly, putting pressure on both the patient and the medical system. For example, the incidence of post-stroke cognitive impairment is high, along with known issues like low cognitive screening rates and identification rate, with limited post-disease intervention options available, together with challenges in intervention and management. In close collaboration with AffaMed and IBT, we will develop highly effective digital assessment and intervention products. Through refined clinical studies and real-world research, we will further improve early screening rates for relevant indications, while bridging the gap in clinical resources and providing digital interventions that are more relevant to patients’ living environments and easier to use and comply with."

Dr. Sun Wei, Founder and Chairman of Beijing Infinite Brain Technologies, said: "With the rich neuroscience data and big data models accumulated over decades, we have been focusing on using proprietary technologies and artificial intelligence to not only accelerate the development of innovative digital therapeutics for multiple neurological diseases but also provide patient-centered digital medical solutions covering the full intervention processes. With this strategic cooperation, we will tap into AffaMed and Beijing Tiantan Hospital’s strong capabilities in clinical development and application, to further promote the development and innovation of digital therapeutics and offer benefit to domestic as well as global patients with better solutions and lower medical costs."

The strategic cooperation between AffaMed, Beijing Tiantan Hospital and IBT will focus on the application of digital therapies in neurological disorders, pooling the three parties’ resources and experience in technology development, clinical design and operation, and clinical practice to verify the safety and efficacy of digital therapies in clinical trials, and jointly promote the development process and application of digital therapies in China.