NMPA

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.

Niterra Invests in Remote Patient Monitoring Startup Vivalink

Retrieved on: 
Thursday, November 9, 2023

SANTA CLARA, Calif., Nov. 9, 2023 /PRNewswire/ -- Niterra (formerly NGK Spark Plug Co. LTD, Headquarters: Higashi-Ku, Nagoya) provided a strategic joint-partnership investment through the CVC fund jointly operated with Pegasus Tech Ventures (Headquarters: CA, USA) to a remote patient monitoring services company, Vivalink Medical, Inc (Headquarters: CA, USA), that specializes in home healthcare, telemedicine, and wearable technology.

Key Points: 
  • "Our vision at Niterra is to improve the quality of life for everybody," said Dirk Schapeler, President of Niterra.
  • "Our vision at Niterra is to improve the quality of life for everybody," said Dirk Schapeler, President of Niterra.
  • "We partner with the best industry professionals and brightest entrepreneurs to develop remote patient monitoring platforms to serve advanced patient care at home and medical environments."
  • Vivalink's biometric platform accelerates the deployment of virtually any type of remote patient monitoring application for healthcare and clinical trials.

Bionano Reports Third Quarter 2023 Results and Highlights Recent Business Progress

Retrieved on: 
Wednesday, November 8, 2023

Publications featuring OGM increased 61% from the third quarter of 2022 to the third quarter of 2023, including a total of 47 human-focused publications.

Key Points: 
  • Publications featuring OGM increased 61% from the third quarter of 2022 to the third quarter of 2023, including a total of 47 human-focused publications.
  • GAAP gross margin for the third quarter of 2023 was 30%, compared to 25% from the third quarter of 2022.
  • Third quarter 2023 non-GAAP¹ gross margin was 32%, compared to 25% from the third quarter of 2022.
  • Third quarter 2023 non-GAAP operating expense was $31.8 million, compared to $26.3 million in the third quarter of 2022 and $34.6 million in the second quarter of 2023.

OmniAb Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Thursday, November 9, 2023

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and nine months ended September 30, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and nine months ended September 30, 2023, and provided operating and partner program updates.
  • As of September 30, 2023, OmniAb had cash, cash equivalents and short-term investments of $96.6 million.
  • Financial results prior to November 1, 2022, are presented on a carve-out basis derived from Ligand’s historical accounting records, as if OmniAb were an independent company.
  • OmniAb management will review third quarter 2023 financial results as part of a Research & Technology virtual event being held today at 11:00 a.m. Eastern time.