National Medical Products Administration

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.

Establishment Labs Announces National Medical Products Administration Approval for Motiva Implants in China

Retrieved on: 
Thursday, November 9, 2023

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced it has received National Medical Products Administration (NMPA) approval in China for Motiva® Implants.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced it has received National Medical Products Administration (NMPA) approval in China for Motiva® Implants.
  • “Our approval in China marks Establishment Labs’ entry into the second largest global and most dynamic market for breast aesthetics in the world,” said Juan José Chacón-Quirós, Chief Executive Officer.
  • “This is the first breast implant technology approved in China in more than a decade.
  • “We transformed the breast aesthetics market in South Korea with Motiva, and we are excited to replicate that success in China,” added John Lim, Founder and CEO of Motiva China Ltd., Establishment Labs exclusive distribution partner in the market.

CASI PHARMACEUTICALS ANNOUNCES MARKET APPROVAL OF CNCT19 BY CHINA NMPA

Retrieved on: 
Wednesday, November 8, 2023

The China National Medical Products Administration (NMPA) has granted market approval for Juventas' investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19), for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China.

Key Points: 
  • The China National Medical Products Administration (NMPA) has granted market approval for Juventas' investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19), for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China.
  • This approval is based on the clinical results from a single-arm, multi-center, pivotal study of 39 adult patients with r/r B-ALL in China.
  • He stated, "The approval of CNCT19 represents a transformative moment not only for CASI and Juventas but for all B-ALL patients in China.
  • CNCT19 offers new hope to patients battling relapsed B-ALL, and this partnership between CASI and Juventas aims to ensure that this innovative therapy reaches those in need across China and beyond."

Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.
  • Dr. Braunstein continued, “We remain acutely focused on advancing our Phase 3 clinical trials in refractory status epilepticus and tuberous sclerosis complex.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.
  • Selected Financial Data (in thousands, except share and per share amounts)

Cytokinetics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023. Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share. Cash, cash equivalents and investments totaled $554.7 million on September 30, 2023.

Key Points: 
  • On Track for Topline Results from SEQUOIA-HCM,
    a Pivotal Phase 3 Clinical Trial of Aficamten in Obstructive HCM,
    the Open-Label Extension Study of Aficamten,
    SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023.
  • Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share.
  • “During the third quarter we made considerable progress across our specialty cardiology franchise, with aficamten remaining our top priority.
  • During the quarter we also started ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM.

C4 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, November 1, 2023

WATERTOWN, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today reported financial results for the third quarter ended September 30, 2023, as well as recent business highlights.

Key Points: 
  • Revenue: Total revenue for the third quarter of 2023 was $11.1 million, compared to $6.8 million for the third quarter of 2022.
  • Research and Development (R&D) Expense: R&D expense for the third quarter of 2023 was $28.3 million, compared to $29.7 million for the third quarter of 2022.
  • Net Loss and Net Loss per Share: Net loss for the third quarter of 2023 was $27.0 million, compared to $32.0 million for the third quarter of 2022.
  • Net loss per share for the third quarter of 2023 was $0.55 compared to $0.65 for the third quarter of 2022.

Amarin Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 1, 2023

-- Company to Host Conference Call Today at 8:00 a.m. ET --

Key Points: 
  • ET --
    DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced financial results for the quarter ended September 30, 2023 and provided an update on company operations.
  • “As we focus on demonstrating results that will drive shareholder value, there are reasons to be optimistic about the future of Amarin,” said Patrick Holt, President & CEO of Amarin.
  • U.S. product net revenue was $62.4 million in the third quarter of 2023, a decline of $2.2 million versus the second quarter of 2023, a decrease of 3% sequentially.
  • The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the company’s historical results from its core business operations.

Burning Rock and Boehringer Ingelheim Achieved a Master Service Agreement in Oncology Companion Diagnostics

Retrieved on: 
Monday, October 30, 2023

GUANGZHOU, China, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that the Company and Boehringer Ingelheim officially have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics.

Key Points: 
  • GUANGZHOU, China, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that the Company and Boehringer Ingelheim officially have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics.
  • This partnership will primarily focus on advancing the clinical trials related to Boehringer Ingelheim's MDM2-p53 antagonist, brigimadlin (BI 907828), and the development of companion diagnostic products in China.
  • Mr. Yusheng Han, Founder and CEO of Burning Rock, expressed, “We are delighted to establish a deep collaboration in companion diagnostics with Boehringer Ingelheim.
  • Burning Rock has a comprehensive layout and supports companion diagnostics development with a global perspective for pharmaceutical companies.

ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023

ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.
  • We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRα.
  • Selling, general and administrative expenses were $37.7 million for the quarter ended September 30, 2023 compared to $33.6 million for the quarter ended September 30, 2022.
  • Capital expenditures were $1.6 million and $1.1 million for the first nine months of 2023 and 2022, respectively.

The 2nd Boao International Conference on Real World Studies of Medical Products Held in Hainan

Retrieved on: 
Friday, November 3, 2023

HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.

Key Points: 
  • HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.
  • The conference featured a plenary session and eight sub-forums, and encompassed various fields related to international real-world research, and the scientific development of pharmaceutical product regulation.
  • According to Deputy Director of Biostatistics and Epidemiology, Real World Evidence Department, Merck, Germany, Real world study is a significant institutional innovation in the Hainan Free Trade Port.
  • "We learnt that four drugs and nine medical devices have been approved by National Medical Products Administration (NMPA) using Real World Data(RWD) from Hainan Boao Lecheng.