National Medical Products Administration

HUTCHMED Initiates SURTORI-01, a Phase III Trial of SULANDA® in Combination with TUOYI® in the Treatment of Advanced Neuroendocrine Carcinoma in China

Tuesday, September 21, 2021 - 1:00am

Treatment related adverse events (TRAEs) were manageable, with surufatinib or toripalimab interruption occurred in 6 (28.6%) and 4 (19%) patients respectively.

Key Points: 
  • Treatment related adverse events (TRAEs) were manageable, with surufatinib or toripalimab interruption occurred in 6 (28.6%) and 4 (19%) patients respectively.
  • The SURTORI-01 Phase III study is a randomized, controlled, open-label, multi-center study where approximately 200 patients are expected to be enrolled.
  • HUTCHMED is the sponsor of SURTORI-01 and responsible for all clinical and regulatory execution of the Phase III study.
  • The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821 ) in patients with advanced pNET in China.

HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced Neuroendocrine Tumors

Monday, September 20, 2021 - 1:00am

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 19, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors (NETs).

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 19, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors (NETs).
  • This Japan study is a two-stage, open label study of surufatinib where approximately 34 patients are expected to be recruited.
  • In Part 2 of the study, efficacy will be assessed in patients with locally advanced or metastatic NETs; the primary outcome measure is objective response rate (ORR).
  • Surufatinib is the third potential new medicine discovered by HUTCHMED to enter into clinical development in Japan.

Celsion and Hainan Poly Pharm Sign Agreement to Manufacture Celsion’s DNA-based Vaccine

Friday, September 17, 2021 - 2:00pm

LAWRENCEVILLE, N.J. and HAINAN, China, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co. Ltd. (Shenzhen Stock Exchange 300630.SZ), a generics manufacturer dedicated to providing therapeutic-value products and services to patients and customers around the world, today announced an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine. Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsion’s vaccine based on its TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.

Key Points: 
  • Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsions vaccine based on its TheraPlas technology.
  • Madame Fang, chief executive officer of Hainan Poly Pharm said, Poly Pharm is a fully-integrated specialty pharmaceutical company with rich CDMO experience.
  • Poly Pharm and Celsion have a successful cooperation on GEN-1 and have been successfully manufacturing clinical batches of GEN-1 to support Celsions OVATION 2 Study in advanced ovarian cancer.
  • Commenting on the agreement, Michael Tardugno, chairman, president and chief executive officer of Celsion said, This is the second plasmid DNA-based investigational new drug project with Hainan Poly Pharm.

Luye Pharma enters into an agreement with ESTEVE to commercialize an Alzheimer's Disease Multi-Day Treatment Patch in Spain

Thursday, September 16, 2021 - 1:29am

BASEL, Switzerland, Sept. 16, 2021 /PRNewswire/ --Luye Pharma Switzerland AG ("Luye Switzerland"), a fully owned subsidiary of Luye Pharma Group (Luye Pharma), and Esteve Pharmaceuticals, S.A. (ESTEVE) announced today that they have entered into an agreement under which ESTEVE receives exclusive rights to commercialize the Rivastigmine Multi-Day Transdermal Patch in Spain.

Key Points: 
  • BASEL, Switzerland, Sept. 16, 2021 /PRNewswire/ --Luye Pharma Switzerland AG ("Luye Switzerland"), a fully owned subsidiary of Luye Pharma Group (Luye Pharma), and Esteve Pharmaceuticals, S.A. (ESTEVE) announced today that they have entered into an agreement under which ESTEVE receives exclusive rights to commercialize the Rivastigmine Multi-Day Transdermal Patch in Spain.
  • Xavier Valera, Managing Director Spain at ESTEVE commented: "This agreement allows ESTEVE to bring this innovative treatment to Spain and to complement our neurology-based portfolio in order to improve the quality oflife of our patients."
  • "The collaboration with ESTEVE represents an important milestone in our commitment to addressing unmet needs for senior patients in Europe.
  • Luye Pharma Group (Luye Pharma), a member of Luye Life Sciences Group, is an international pharmaceutical company dedicated to the R&D, manufacturing, and sale of innovative medications.

Hua and Sinopharm Announced Supply Chain Strategic Cooperation

Wednesday, September 15, 2021 - 6:35am

SHANGHAI, CHINA, Sept 15, 2021 - (ACN Newswire) - On September 13, 2021, Hua Medicine (Shanghai) Ltd. (the "Hua Medicine", Stock Code: 2552.HK) has signed a supply chain strategic cooperation agreement with Sinopharm Group Co., Ltd. (the "Sinopharm", Stock Code: 1099).

Key Points: 
  • SHANGHAI, CHINA, Sept 15, 2021 - (ACN Newswire) - On September 13, 2021, Hua Medicine (Shanghai) Ltd. (the "Hua Medicine", Stock Code: 2552.HK) has signed a supply chain strategic cooperation agreement with Sinopharm Group Co., Ltd. (the "Sinopharm", Stock Code: 1099).
  • Hua Medicine will rely on Sinopharm's nation-wide drug distribution network to carry out in-depth cooperation in supply chain management.
  • "We are very glad to witness the strategic cooperation between Sinopharm and Hua Medicine, opening a new chapter on our cooperation.
  • In recent years, Sinopharm continue to innovate and build up the new ecosystem of the smart pharmaceutical and supply chain, improving the efficiency of supply chain.

Zai Lab Announces Breakthrough Therapy Designation Granted for Bemarituzumab (FPA144) in China

Tuesday, September 14, 2021 - 12:30pm

In granting Breakthrough Therapy Designation, we are pleased to see that the CDE recognizes the promise of bemarituzumab.

Key Points: 
  • In granting Breakthrough Therapy Designation, we are pleased to see that the CDE recognizes the promise of bemarituzumab.
  • The Breakthrough Therapy Designation was granted based upon this subset of patients, based on IHC testing, showing at least 10% of tumor cells overexpressing FGFR2b.
  • Drugs that have been granted the Breakthrough Therapy Designation are prioritized by the CDE in communications, and in receiving guidance to promote the drug development progress.
  • Zai Lab has an exclusive license to develop and commercialize bemarituzumab in Greater China.

Y-mAbs Announces Priority Review of BLA for DANYELZA® (naxitamab-gqgk) in China

Monday, September 13, 2021 - 2:00pm

We are pleased to see SciClone Pharmaceuticals receive priority review of the DANYELZA BLA in China.

Key Points: 
  • We are pleased to see SciClone Pharmaceuticals receive priority review of the DANYELZA BLA in China.
  • Priority review in China is intended to expedite review and approval, which means that we could potentially be facing approval and launch of DANYELZA in China as soon as the first quarter of 2022, commented Thomas Gad, founder, Chairman and President at Y-mAbs.
  • Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs.
  • DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis.

SCYNEXIS Announces Hansoh Pharma’s Application to National Medical Products Administration (NMPA) in China for Phase 3 Trial of Ibrexafungerp for Treatment of Vulvovaginal Candidiasis (VVC)

Monday, September 13, 2021 - 1:30pm

Earlier this year, SCYNEXIS signed an exclusive licensing agreement and strategic partnership with Hansoh Pharma, one of the leading biopharmaceutical companies in China, to research, develop and commercialize ibrexafungerp in the Greater China region.

Key Points: 
  • Earlier this year, SCYNEXIS signed an exclusive licensing agreement and strategic partnership with Hansoh Pharma, one of the leading biopharmaceutical companies in China, to research, develop and commercialize ibrexafungerp in the Greater China region.
  • This clinical trial application is a critical first step as Hansoh works to develop and bring this groundbreaking antifungal treatment to potentially millions of patients in China, said Marco Taglietti, M.D., President and CEO of SCYNEXIS.
  • We believe Hansoh Pharma has exactly the right capabilities and expertise to successfully develop and commercialize ibrexafungerp in China, and we are thrilled to see the team achieve this important milestone.
  • Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids.

HUTCHMED Receives Breakthrough Therapy Designation in China for Amdizalisib (HMPL-689) for Treatment of Relapsed or Refractory Follicular Lymphoma

Monday, September 13, 2021 - 7:00am

This indicates that the development and review of amdizalisib for relapsed or refractory FL may be expedited, to address patients' unmet needs more quickly.

Key Points: 
  • This indicates that the development and review of amdizalisib for relapsed or refractory FL may be expedited, to address patients' unmet needs more quickly.
  • In April 2021, HUTCHMED initiated a Phase II registration study in China for amdizalisib in approximately 100 patients with relapsed or refractory FL and approximately 80 patients with marginal zone lymphoma (MZL).
  • Amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory NHL ( NCT03786926 ).
  • Patients with relapsed or refractory FL do not have curative treatment options and have a high unmet need for optimal therapeutic options.

Happiness Biotech Announced The Launch of Its Lucidum Tablets on DouYin Mall

Friday, September 10, 2021 - 1:00pm

NANPING, China, Sept. 10, 2021 /PRNewswire/ -- Happiness Biotech Group Limited (the "Company" or Nasdaq: HAPP), an innovative China-based nutraceutical and dietary supplements producer and e-commerce services provider, today announced one of its nutraceutical products - Lucidum Tablets, have been launched for sale on the DouYin Mall, a virtual mall built within a Douyin mini-program.

Key Points: 
  • NANPING, China, Sept. 10, 2021 /PRNewswire/ -- Happiness Biotech Group Limited (the "Company" or Nasdaq: HAPP), an innovative China-based nutraceutical and dietary supplements producer and e-commerce services provider, today announced one of its nutraceutical products - Lucidum Tablets, have been launched for sale on the DouYin Mall, a virtual mall built within a Douyin mini-program.
  • Happiness was successfully and officially invited by DouYin Mall to open its store and its Lucidum Tablets is the first lucidum product to be sold on such e-commerce platform.
  • Lucidum Tablets is our first product launched in DouYin Mall.
  • Headquartered in Nanping, China, Happiness Biotech Group Limited currently has three business linesnutraceutical and dietary supplements, e-commerce and auto sales.