ALT02 (trastuzumab biosimilar) / Alteogen, Qilu Pharma, Cristalia - LARVOL DELTA

QL1701 (a proposed trastuzumab biosimilar) versus reference trastuzumab plus docetaxel as first-line therapy for HER2-positive metastatic breast cancer: a multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial. (PubMed, ESMO Open) - "QL1701 demonstrated equivalent efficacy and similar safety to the reference trastuzumab when combined with docetaxel in the first-line treatment of patients with HER2-positive metastatic breast cancer, with similar PK and immunogenicity profiles."

Clinical • Journal • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Will Alteogen's stock price soar?... Attention on Herceptin biosimilar drugs [Google translation] (Pinpoint News) - "According to the Korea Exchange on the 24th, it closed at 285,500 won, up 8.14% from the previous trading day....The recent news that China's Qilu Pharmaceutical's Herceptin biosimilar ALT-L2 received product approval from the China National Center for Medical Products Evaluation (CDE) appears to be giving a boost to the stock price."

Stock price • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Alteogen, Herceptin Biosimilar 'ALT-L2' Approved in China [Google translation] (HIT News) - "Alteogen...announced on the 12th that it had received notification from China's Qilu Pharmaceutical that its Herceptin biosimilar 'ALT-L2' had obtained product approval from the National Center for Product Evaluation (CDE) under the China Medical Products Administration....Afterwards, it completed phase 3 clinical trials in China in 2022, applied for product approval in April of last year, and obtained product approval this month."

China approval • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=474 | Completed | Sponsor: Qilu Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Metastases • Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Alteogen receives milestone with completion of clinical trial for 'ALT-L2' by Qilu Pharmaceutical in China [Google translation] (HIT News) - "Alteogen...announced on the 2nd that it has received a milestone for the completion of clinical trials for Herceptin biosimilar 'ALT-L2 (development code name)' from Qilu Pharmaceutical in China....According to the company, receipt of this milestone is a confirmation of Qilu Pharmaceutical's intention to commercialize ALT-L2. This is because the costly Phase 3 clinical trial was conducted, the Clinical Result Report (CSR) was received, and product approval for marketing was obtained."

Non-US regulatory • Trial completion • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Alteogen ’Billing milestone to Qilu Pharmaceutical based on completion of Herceptin biosimilar clinical trial’ [Google translation] (Nate) - "Qilu Pharmaceutical's Herceptin biosimilar is currently seeking approval in China and is expected to obtain product approval within the year....Alteogen expects ALT-L2 to be competitive in the Chinese market thanks to the capabilities of its partners."

Commercial • Non-US regulatory • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Alteogen commercializes - recruits key talent for development of follow-up pipeline [Google translation] (Pharm News) - "Alteogen is conducting clinical trials for approval of two SC formulation treatments using Hybrozyme™ platform technology, as well as Eylea^® biosimilar ALT-L9, which is in the final phase 3 global clinical trial, and is being clinically conducted by a partner company in China. We are pursuing commercialization around 2025 for various products, including Herceptin^® biosimilar ALT-L2, which has completed Phase 3."

Commercial • Trial completion • Age-related Macular Degeneration • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Macular Degeneration • Oncology • Ophthalmology • Solid Tumor • Wet Age-related Macular Degeneration

A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=474 | Active, not recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Trial completion date: Apr 2023 ➔ Oct 2023 | Trial primary completion date: Aug 2022 ➔ Dec 2022

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=474 | Active, not recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

[VIRTUAL] First-in-human phase I study of ALT-P7, a HER2-targeting antibody-drug conjugate in patients with HER2-positive advanced breast cancer. (ASCO 2020) - P1 | "Background: ALT-P7 is an antibody-drug conjugate, in which two molecules of monomethyl auristatin E (MMAE) are site-specifically conjugated to a cysteine-containing peptide motif of trastuzumab variant. ALT-P7 was well tolerated to a dose of 4.2mg/kg in heavily pretreated HER2-positive advanced breast cancer. DLTs were observed at 4.8mg/kg, and 4.5mg/kg is under evaluation. The observed clinical activity warrants further evaluation in a phase 2 trial."

Clinical • P1 data • Alopecia • Breast Cancer • Cardiovascular • Dermatology • Dermatopathology • Fatigue • Gene Therapies • Heart Failure • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Pain • Pruritus • Solid Tumor • Thrombocytopenia • HER-2

Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Alteogen, Inc.; Enrolling by invitation ➔ Recruiting; Trial completion date: Mar 2019 ➔ Oct 2020; Trial primary completion date: Dec 2018 ➔ Jun 2020

Clinical • Enrollment status • Trial completion date • Trial primary completion date

China OKs Alteogen’s Herceptin biosimilar for clinical trials (Korea Biomedical Review) - "Alteogen said that Qilu Pharmaceutical, its Chinese partner, has received investigational new drug (IND) approval for ALT-02, a Herceptin biosimilar, from the China Food and Drug Administration."

IND