National Medical Products Administration

IASO Bio Establishes International CAR-T Diagnostic and Treatment Center in China to Serve MM Patients Worldwide

Retrieved on: 
Tuesday, November 21, 2023

Nanjing IASO Biotechnology Co., Ltd. (IASO Bio) made its debut at the 6th China International Import Expo (CIIE) with FUCASO, the world's first fully-human CAR-T, and entered into a strategic partnership with several international medical institutions, bringing hope for cure to multiple myeloma (MM) patients worldwide.

Key Points: 
  • Nanjing IASO Biotechnology Co., Ltd. (IASO Bio) made its debut at the 6th China International Import Expo (CIIE) with FUCASO, the world's first fully-human CAR-T, and entered into a strategic partnership with several international medical institutions, bringing hope for cure to multiple myeloma (MM) patients worldwide.
  • On June 30, 2023, the China National Medical Products Administration (NMPA) approved the marketing of Equecabtagene Autoleucel Injection (brand name: FUCASO) for the treatment of adult patients with relapsed or refractory multiple myeloma (r/rMM).
  • FUCASO has attracted patients from numerous countries around the world to seek treatment in Chinese hospitals in just 4 months since its approval for marketing in China.
  • In addition, the cost of treatment with FUCASO in China is significantly lower than that of similar products in Europe and America, which has benefited more patients worldwide.

Crystal Pharmatech's CDMO Business Unit successfully passed the dual certification of GMP and GDP conducted by SGS

Retrieved on: 
Monday, December 4, 2023

SUZHOU, China, Dec. 4, 2023 /PRNewswire/ -- Recently, Crystal Pharmatech's CDMO Business Unit - Crystal Formulation Services (CFS) successfully obtained dual certification in Good Manufacturing Practices (GMP)[1] and Good Distribution Practices (GDP)[2] from SGS, an internationally recognized third-party certification agency, in line with the World Health Organization (WHO) standards.

Key Points: 
  • SUZHOU, China, Dec. 4, 2023 /PRNewswire/ -- Recently, Crystal Pharmatech's CDMO Business Unit - Crystal Formulation Services (CFS) successfully obtained dual certification in Good Manufacturing Practices (GMP)[1] and Good Distribution Practices (GDP)[2] from SGS, an internationally recognized third-party certification agency, in line with the World Health Organization (WHO) standards.
  • During the certification inspection, SGS dispatched experienced certification inspectors for a comprehensive one-week on-site evaluation of CFS.
  • As a leading global third-party independent audit and certification organization, SGS issues compliance certificates based on WHO GMP/GDP guidelines, which are widely acknowledged and esteemed within the industry.
  • We also appreciate the efforts of our team members and the authoritative certification from SGS, which has provided a prestigious endorsement for our clinical supply business.

Innovent Presents Clinical Data Update of IBI351 (KRAS G12C Inhibitor) Monotherapy in Lung Cancer and Colorectal Cancer at ESMO Asia Congress 2023

Retrieved on: 
Friday, December 1, 2023

As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:

Key Points: 
  • As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:
    IBI351 demonstrated encouraging antitumor activity.
  • IBI351 as a selective covalent irreversible KRAS G12C inhibitor, its monotherapy has demonstrated outstanding efficacy and manageable safety in advanced colorectal cancer with KRAS G12C mutation.
  • Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 ESMO Asia Congress.
  • We will continue to explore the clinical development of IBI351 monotherapy and combination therapy in the fields of lung cancer, colorectal cancer and other solid tumors to benefit more cancer patients ."

Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China

Retrieved on: 
Wednesday, November 29, 2023

OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix® (APL-1706) in China.

Key Points: 
  • OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix® (APL-1706) in China.
  • Hexvix, a pharmaceutical product used in the detection of bladder cancer, was licensed to Asieris by Photocure in January 2021, for the registration and commercialization of Hexvix in mainland China and Taiwan.
  • Moreover, Asieris' Phase III Hexvix trial is the first RCT that was conducted with high definition 4K blue light capital equipment.
  • The acceptance of the Hexvix submission by NMPA is the positive outcome of months of collaboration between the Asieris and Photocure teams," said Dan Schneider, President and CEO of Photocure.

Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China

Retrieved on: 
Wednesday, November 29, 2023

OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix® (APL-1706) in China.

Key Points: 
  • OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix® (APL-1706) in China.
  • Hexvix, a pharmaceutical product used in the detection of bladder cancer, was licensed to Asieris by Photocure in January 2021, for the registration and commercialization of Hexvix in mainland China and Taiwan.
  • Moreover, Asieris' Phase III Hexvix trial is the first RCT that was conducted with high definition 4K blue light capital equipment.
  • The acceptance of the Hexvix submission by NMPA is the positive outcome of months of collaboration between the Asieris and Photocure teams," said Dan Schneider, President and CEO of Photocure.

Ascentage Pharma Hosts Ceremony Marking the Launch of Olverembatinib in Newly Approved Indication and the Dispatch of First Batch for the New Indication

Retrieved on: 
Friday, November 24, 2023

Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).

Key Points: 
  • Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China.
  • Ascentage Pharma and Innovent are mutually committed to the commercialization of olverembatinib in the China market.
  • Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up.

Calliditas' partner Everest Medicines announces China NMPA's approval of Nefecon® for the treatment of primary IgA nephropathy

Retrieved on: 
Friday, November 24, 2023

China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.

Key Points: 
  • China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.
  • There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.
  • Everest also announced that, in addition to Nefecon's approval in mainland China and Macau, it expects a decision on New Drug Application (NDA) approval in Singapore and Hong Kong in the near term.
  • This approval triggers a milestone payment of five million USD to Calliditas, which will be included as revenue in the fourth quarter.

Calliditas' partner Everest Medicines announces China NMPA's approval of Nefecon® for the treatment of primary IgA nephropathy

Retrieved on: 
Friday, November 24, 2023

China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.

Key Points: 
  • China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients.
  • There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.
  • Everest also announced that, in addition to Nefecon's approval in mainland China and Macau, it expects a decision on New Drug Application (NDA) approval in Singapore and Hong Kong in the near term.
  • This approval triggers a milestone payment of five million USD to Calliditas, which will be included as revenue in the fourth quarter.

Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Accepted the New Drug Application for Taletrectinib (ROS1 Inhibitor)

Retrieved on: 
Wednesday, November 22, 2023

The NDA acceptance are based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.

Key Points: 
  • The NDA acceptance are based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.
  • I hope this NDA represents a step towards making another option available to the ROS1-positive NSCLC patient community in China."
  • Bing Yan, MD, Chief Medical Officer of AnHeart, stated: "Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally.
  • In June 2021, Innovent and AnHeart entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2023 BUSINESS AND FINANCIAL UPDATES

Retrieved on: 
Tuesday, November 14, 2023

BEIJING, Nov. 14, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • BEIJING, Nov. 14, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the third quarter ended September 30, 2023.
  • He further added, "Our sales revenue for the third quarter of 2023 was $8.8 million, representing a decrease of 13.5% compared to the same period last year and a decrease of 10% from the second quarter of 2023.
  • Revenue was $8.8 million for the three months ended September 30, 2023, compared to $10.2 million for the three months ended September 30, 2022.
  • As of September 30, 2023, CASI had cash, cash equivalents and short-term investments of $34.2 million.