PharmaShots

AffaMed Therapeutics’ AMT901 (biosimilar, trastuzumab) Receives NMPA’s Approval to Initiate P-III Clinical Study in China

December 11, 2019December 11, 2019Tuba Khan

Shots: The NMPA has granted CTA approval to AffaMed to conduct a clinical study evaluating AMT901/ SB3, a biosimilar referencing Roche’s Herceptin. The [Read More...]

Merck and Ping An Good Doctor Collaborate to Support Health Management in China

Merck KGaA and Ping An Good Doctor Collaborate to Support Health Management in China

December 4, 2019December 4, 2019Tuba Khan

Shots: Merck KGaA and Ping An Good Doctor jointly explore integrated solutions to advance intelligent healthcare in China, addressing the unmet medical needs. [Read More...]

Bio Thera’s QLETLI (biosimilar, adalimumab) Receives NMPA’s Approval for Auto-Immune Diseases in China

November 7, 2019November 7, 2019Tuba Khan

Shots: The approval of QLETLI is based on P-III study resulted in meeting its 1EPs, demonstrating bio-similarity to the reference product, Humira (adalimumab) [Read More...]

AstraZeneca to Invest $1B for the Transformation of Healthcare in China

November 7, 2019November 7, 2019Tuba Khan

Shots: AstraZeneca takes three large-scale initiatives which include the formation of new Global R&D Centre and an AI Innovation Centre, both in Shanghai [Read More...]

Henlius and Ascentage Pharma Collaborate to Evaluate the Combination Therapy for Chronic Lymphocytic Leukemia in China

November 5, 2019November 5, 2019Tuba Khan

Shots: The companies collaborated to conduct the clinical studies of a dual regimen consisting of Ascentage’s APG-2575 and Henlius’s HLX01 (biosimilar, rituximab) for [Read More...]

Amgen Acquires Stake in BeiGene to Expand its Oncology Portfolio in China

November 1, 2019November 1, 2019Tuba Khan

Shots: BeiGene to commercialize Amgen’s Xgeva (denosumab), Kyprolis (carfilzomib) and Blincyto (blinatumomab) in China (Ex- Hong Kong, Macao & Taiwan) for 5 or [Read More...]

NovoCodex Collaborates with Ambrx to Develop and Commercialize its ARX305 in China

October 24, 2019October 24, 2019Shiwani Sharma

Shots: Ambrx to receive up front, development milestones and royalties on sales of ARX305 in China and retain rights to develop & commercialize [Read More...]

Merck’s Keytruda Receives NMPA’s Approval as Monotherapy for 1L Treatment of Advanced Non-Small Cell Lung Cancer with PD-L1 Tumor Expression in China

October 3, 2019October 3, 2019Shiwani Sharma

Shots: The NMPA approval is based on the P-III KEYNOTE-042 study assessing Keytruda as monothx. vs CT in patients with stage III NSCLC [Read More...]

Simcere Signs an Exclusive License Agreement with JW Pharmaceutical for an Anti-Gout Drug Candidate URC-102 in China

September 27, 2019September 27, 2019Shiwani Sharma

Shots: JWP to receive up front, commercial milestones & royalties on sales in China. Simcere to get the license for clinical research, registration, [Read More...]

AstraZeneca Amends its Development and Commercialization Agreement with Ironwood for Linzess (linaclotide) Signed in 2012

September 18, 2019September 18, 2019Tuba Khan

Shots: Ironwood to receive three non-contingent payment of $35M b/w 2021 & 2024, ~$90M as a milestone with royalties on sales of Linzess [Read More...]