On July 30, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the U.S. Food and Drug Administration (FDA) has allowed the Company’s IND application for its ADXS-HOT drug candidate for non-small cell lung cancer (NSCLC) (Press release, Advaxis, JUL 30, 2018, View Source [SID1234527954]). Advaxis anticipates that because of this timely allowance, the first patient in the Phase 1/2 trial for this NSCLC drug candidate will be dosed by the end of 2018.

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ADXS-HOT is a cancer-type specific immunotherapy approach that leverages the Company’s proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary tumor-associated antigens. To date, more than 10 drug candidates have been designed for different tumor types in the ADXS-HOT program.

"This is an exciting time for Advaxis as we prepare to initiate the first clinical trial with a drug candidate from our ADXS-HOT program. This drug candidate, ADXS-503, has been designed for the treatment of patients with NSCLC," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "With our increased strategic focus on neoantigen-based therapeutics, including the personalized, patient-specific approach of our ADXS-NEO program, already in a clinical trial, we anticipate having five neoantigen-based drug candidates in clinical evaluation by the end of 2019. Our next two ADXS-HOT drug candidates will focus on prostate and bladder cancers. These two tumor types, along with NSCLC, were prioritized based on our evaluation of a number of factors relating to each, including the unmet medical need, time and investment required to demonstrate meaningful clinical activity and immunological sensitivity," concluded Mr. Berlin.

The Company plans to initiate a Phase 1/2 clinical trial that will seek to establish the safety, tolerability and effectiveness of ADXS-503 administered alone and in combination with a checkpoint inhibitor in approximately 50 patients with metastatic NSCLC in different lines of therapy, at up to 20 centers across the U.S.

"I am pleased we can move forward to advance our first trial with ADXS-503, the first drug candidate in our ADXS-HOT program. This is an important clinical milestone as we seek to demonstrate proof-of-concept for ADXS-HOT immunotherapy in NSCLC, where there remains significant unmet need despite the introduction of checkpoint inhibitors and targeted therapies," said Andres Gutierrez, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Advaxis. "Earlier drug candidates from our Lm platform expressing a single antigen have shown a favorable safety profile and preliminary clinical activity in more than 500 subjects treated to date across different tumor types. This clinical experience with prior Lm drug candidates, combined with our ability to leverage the large capacity of our Lm vector to express multiple neoantigens and other tumor-associated antigens, provides the foundation for our belief that ADXS-HOT drug candidates such as ADXS-503 for NSCLC can provide a new standard for off- the-shelf neoantigen vaccines."

Advaxis affirms plans to submit a total of four INDs for drug candidates from its ADXS-HOT program by the fourth quarter of 2019. Beyond NSCLC, prostate cancer and bladder cancer, the fourth ADXS-HOT drug candidate will be selected from breast, colorectal, ovarian or head and neck cancers.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. Although ADXS-HOT drug candidates have not yet been tested in patients, they are an off-the-shelf treatment approach been designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.

About ADXS-NEO

ADXS-NEO is an investigational personalized Lm-based immunotherapy designed to generate immune response against mutation-derived tumor-specific neoantigens identified through DNA sequencing of a patient’s own tumors. The program focuses on creating a customized treatment for each patient targeting multiple neoantigens found in a biopsy of the patient’s tumor. ADXS- NEO is being developed in partnership with Amgen.

On July 27, 2018 Array BioPharma Inc. (NASDAQ: ARRY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BRAFTOVI in combination with MEKTOVI for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation (Press release, Array BioPharma, JUL 27, 2018, View Source [SID1234527926]). The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The final EC decision, expected by the end of September, will be applicable to all 28 EU member states, as well as Liechtenstein, Iceland and Norway.

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"Following the recent U.S. FDA approval of BRAFTOVI + MEKTOVI for advanced BRAF-mutant melanoma, we are pleased to move one step closer to European approval," said Ron Squarer, Chief Executive Officer. "We are proud that the combination of BRAFTOVI + MEKTOVI represents a new standard of care for BRAF-mutant melanoma patients in critical need of additional treatment options."

The positive CHMP opinion is based on results from the Phase 3 COLUMBUS trial, which demonstrated that the combination BRAFTOVI + MEKTOVI achieved a median progression-free survival (mPFS) of nearly 15 months [14.9 months versus vemurafenib monotherapy at 7.3 months; hazard ratio (HR) 0.54 (95% CI, 0.41–0.71), p<0.0001].

In June 2018, Array also announced updated results from the COLUMBUS trial, which demonstrated that BRAFTOVI + MEKTOVI was the first targeted therapy to achieve over 30 months overall survival (OS) in a Phase 3 trial and reduced the risk of death compared to treatment with vemurafenib [HR (0.61), (95% CI 0.47-0.79, p <0.0001]. Median OS was 33.6 months for patients treated with the combination, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.

The most common grade 3-4 adverse events seen in more than 5% of patients were increased gamma-glutamyltransferase (9%), increased blood creatine phosphokinase (7%) and hypertension (6%).

In the U.S., BRAFTOVI + MEKTOVI are approved for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma.

Only 5% of patients who received BRAFTOVI + MEKTOVI discontinued treatment due to adverse reactions. The most common adverse reactions (≥25%) in patients receiving BRAFTOVI + MEKTOVI were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.

Detailed recommendations for the use of these products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official EU languages after the marketing authorization has been granted by the EC. Pierre Fabre has exclusive rights to commercialize both products in Europe, Asia and Latin America.

About BRAF-mutant Metastatic Melanoma
Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumors. Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. [1,2] There are a variety of gene mutations that can lead to metastatic melanoma. The most common genetic mutation in metastatic melanoma is BRAF. There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma. [1-5]

About BRAFTOVI + MEKTOVI
BRAFTOVI is an oral small molecule BRAF kinase inhibitor and MEKTOVI is an oral small molecule MEK inhibitor which target key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma, colorectal cancer, non-small cell lung cancer, thyroid and others. In the U.S., BRAFTOVI + MEKTOVI are approved for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma.

Array has exclusive rights to BRAFTOVI and MEKTOVI in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea, Medison exclusive rights to commercialize both products in Israel and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America.

BRAFTOVI and MEKTOVI are not approved outside of the United States. The European Medicines Agency (EMA), the Swiss Medicines Agency (Swissmedic) and the Australian Therapeutic Goods Administration (TGA) are currently reviewing the Marketing Authorization Applications, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan is currently reviewing the Manufacturing and Marketing Approval Applications for BRAFTOVI and MEKTOVI.

About COLUMBUS
The COLUMBUS trial (NCT01909453) is a two-part, international, randomized, open label Phase 3 trial evaluating the efficacy and safety of BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation. All secondary efficacy analyses, including overall survival, are descriptive in nature. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial.

Indications and Usage
BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are kinase inhibitors indicated for use in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.

Limitations of Use: BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma.

BRAFTOVI + MEKTOVI Important Safety Information
The information below applies to the safety of the combination of BRAFTOVI and MEKTOVI unless otherwise noted.

Warnings and Precautions
New Primary Malignancies: New primary malignancies, cutaneous and non-cutaneous malignancies can occur. In the COLUMBUS trial, cutaneous squamous cell carcinoma, including keratoacanthoma, occurred in 2.6% and basal cell carcinoma occurred in 1.6% of patients. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies.

Tumor Promotion in BRAF Wild-Type Tumors: Confirm evidence of BRAFV600E or BRAFV600Kmutation prior to initiating BRAFTOVI.

Cardiomyopathy: In the COLUMBUS trial, cardiomyopathy occurred in 7% and Grade 3 left ventricular dysfunction occurred in 1.6% of patients. Cardiomyopathy resolved in 87% of patients. Assess left ventricular ejection fraction by echocardiogram or MUGA scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal.

Venous Thromboembolism (VTE): In the COLUMBUS trial, VTE occurred in 6% of patients, including 3.1% of patients who developed pulmonary embolism.

Hemorrhage: In the COLUMBUS trial, hemorrhage occurred in 19% of patients and ≥Grade 3 hemorrhage occurred in 3.2% of patients. Fatal intracranial hemorrhage in the setting of new or progressive brain metastases occurred in 1.6% of patients.

Ocular Toxicities: In the COLUMBUS trial, serous retinopathy occurred in 20% of patients; 8% were retinal detachment and 6% were macular edema. Symptomatic serous retinopathy occurred in 8% of patients with no cases of blindness. In patients with BRAF mutation-positive melanoma across multiple clinical trials, 0.1% of patients experienced retinal vein occlusion (RVO). Permanently discontinue MEKTOVI in patients with documented RVO. In COLUMBUS, uveitis, including iritis and iridocyclitis, was reported in 4% of patients. Assess for visual symptoms at each visit. Perform ophthalmic evaluation at regular intervals and for any visual disturbances.

Interstitial Lung Disease (ILD): ILD, including pneumonitis, occurred in 0.3% of patients with BRAF mutation-positive melanoma across multiple clinical trials. Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD.

Hepatotoxicity: In the COLUMBUS trial, the incidence of Grade 3 or 4 increases in liver function laboratory tests was 6% for alanine aminotransferase (ALT) and 2.6% for aspartate aminotransferase (AST). Monitor liver laboratory tests before and during treatment and as clinically indicated.

Rhabdomyolysis: In the COLUMBUS trial, elevation of laboratory values of serum creatine phosphokinase (CPK) occurred in 58% of patients. Rhabdomyolysis was reported in 0.1% of patients with BRAF mutation-positive melanoma across multiple clinical trials. Monitor CPK periodically and as clinically indicated.

QTc Prolongation: In the COLUMBUS trial, an increase in QTcF to >500 ms was measured in 0.5% (1/192) of patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

Embryo-Fetal Toxicity: BRAFTOVI or MEKTOVI can cause fetal harm when administered to pregnant women. Nonhormonal contraceptives should be used during treatment and for at least 30 days after the final dose for patients taking BRAFTOVI + MEKTOVI.

Adverse Reactions
The most common adverse reactions (≥20%, all Grades, in the COLUMBUS trial) were: fatigue, nausea, diarrhea, vomiting, abdominal pain, arthralgia, myopathy, hyperkeratosis, rash, headache, constipation, visual impairment, serous retinopathy.

In the COLUMBUS trial, the most common laboratory abnormalities (≥20%, all Grades) included: increased creatinine, increased CPK, increased gamma glutamyl transferase, anemia, increased ALT, hyperglycemia, increased AST, and increased alkaline phosphatase.

Drug interactions
Avoid concomitant use of strong or moderate CYP3A4 inhibitors or inducers and sensitive CYP3A4 substrates with BRAFTOVI. Modify BRAFTOVI dose if concomitant use of strong or moderate CYP3A4 inhibitors cannot be avoided.

Please see full Prescribing Information for BRAFTOVI and full Prescribing Information for MEKTOVI for additional information. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Array at 1-844-Rx-Array (1-844-792-7729).

On July 27, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorisation of Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT) (Press release, AstraZeneca, JUL 27, 2018, View Source [SID1234527927]). The recommendation is based on the progression-free survival (PFS) and overall survival (OS) primary endpoints of the Phase III PACIFIC trial, and post-hoc subgroup analyses by PD-L1 expression requested by the CHMP.

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Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The CHMP positive opinion brings European patients closer to having a treatment following chemoradiation therapy. There have been no new treatments in this setting for decades. With approximately a third of European non-small cell lung cancer patients presenting with this stage of disease, we are excited by this potential new standard of care in this curative-intent setting."

In the PACIFIC trial, Imfinzi demonstrated a statistically-significant and clinically-meaningful improvement in PFS and OS in "all-comer" patients. The recommended label reflects most of the patients in the trial with a known PD-L1 status.

Overall survival results from the PACIFIC trial will be presented at a forthcoming medical meeting.

The positive opinion from the CHMP will now be reviewed by the European Commission, which has the authority to approve medicines for the 28 European Union member countries plus Iceland, Norway and Liechtenstein. Earlier this year, Imfinzi was approved for unresectable, Stage III NSCLC in the US, Canada, Switzerland, India, Japan and Brazil based on the Phase III PACIFIC trial. In addition to the EU, other global health authority reviews and submissions are ongoing.

About Stage III NSCLC

Stage III (locally advanced) NSCLC is commonly divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. Stage III disease is different from Stage IV disease, when the cancer has spread (metastasised) to distant organs, as Stage III is currently treated with curative intent.

Stage III NSCLC represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the top-eight countries (China, France, Germany, Italy, Japan, Spain, UK, US) in 2017. The majority of Stage III NSCLC patients are diagnosed with unresectable tumours. No new treatments beyond chemoradiation therapy, followed by active surveillance to monitor for progression, have been available to patients for decades.

About PACIFIC

The PACIFIC trial is a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as treatment in ‘all-comer’ patients (i.e. regardless of PD-L1 status) with unresectable, Stage III NSCLC whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).

The trial is being conducted in 235 centres across 26 countries involving 713 patients. The primary endpoints of the trial are PFS and OS, and secondary endpoints include landmark PFS and OS, objective response rate, and duration of response.

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III NSCLC in the US, Canada, Switzerland, India, and Japan based on the Phase III PACIFIC trial.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal antibody, as a first or second-line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.

About AstraZeneca in Lung Cancer

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths.

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer across all stages of disease and lines of therapy. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa and Tagrisso and ongoing FLAURA, ADAURA and LAURA Phase III trials. Our extensive late-stage immuno-oncology programme focuses on 75-80% of patients with lung cancer without a known genetic mutation. The portfolio includes Imfinzi, an anti-PDL1 antibody, which is in development as monotherapy (ADJUVANT BR.31, PACIFIC2, MYSTIC and PEARL Phase III trials) and in combination with tremelimumab and/or chemotherapy (MYSTIC, NEPTUNE, POSEIDON and CASPIAN Phase III trials).

About AstraZeneca’s Approach to Immuno-Oncology (IO)

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical trial programme that includes Imfinzi (anti-PDL1) as monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours

On July 27, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported that its second quarter 2018 financial results will be reported on Tuesday, August 7, 2018 (Press release, BioCryst Pharmaceuticalsa, JUL 27, 2018, View Source [SID1234527928]).

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BioCryst will host a conference call and webcast at 11:00 a.m. Eastern Time to discuss financial results and to provide an update regarding the Company’s clinical development programs. The call will be led by Jon P. Stonehouse, President & Chief Executive Officer, Thomas R. Staab II, Senior Vice President & Chief Financial Officer, Lynne Powell, Senior Vice President & Chief Commercial Officer, and Dr. Bill Sheridan, Senior Vice President and Chief Medical Officer.

Links to a live audio webcast and replay of the presentation may be accessed on the BioCryst website events page at View Source

On July 27, 2018 Shanghai HaiHe Biopharma Co., Ltd. ("HaiHe Biopharma") and DAEHWA Pharmaceutical Co., Ltd. ("DAEHWA Pharma") reported, RMX3001, co-developed by both companies, has been granted the clinical trial approval (CTA) for gastric cancer by China National Drug Administration (CNDA) (Press release, Daehwa Pharmaceutical, JUL 27, 2018, View Source [SID1234593982]). At the same time, IND filing for breast cancer phase III multi-regional clinical trial (MRCT) was also accepted by CNDA.

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Dr. Ruiping Dong, CEO of HaiHe Biopharma, commented,
"We are very pleased that RMX3001 project has been granted CTA by CNDA in only 4 months. This approval is undoubtedly good news for Chinese cancer patients. We will immediately advance clinical trials for gastric cancer. As the world’s first successfully developed oral paclitaxel, RMX3001 was developed under a unique and innovative oral formulation process. It needs no premedication before treatment, and is convenient to use with less adverse reactions such as peripheral neuropathy, contributes to high patient compliance. We look forward to the launch of RMX3001 as soon as possible to benefit cancer patients."

Mr. Eun-Seok Kim, President and CEO of DAEHWA Pharma, commented,
"With the support and assistance of friends from HaiHe Pharma, RMX3001 (DHP1007/ Liporaxel) project co-developed by both companies has progressed faster than expected, having obtained CTA for gastric cancer, and IND filing for breast cancer phase III MRCT accepted by CNDA. We are eagerly looking forward to the early initiations of clinical trials in China, and we hope that both companies will work together closely to write a new history of Chinese and global anticancer drugs."

About RMX3001
Paclitaxel is one of the most widely used drug for chemotherapy. There are huge market needs in China, with Paclitaxel usage by 220,000 patients of gastric cancer, breast cancer, ovary cancer and lung cancer alone. Currently used Paclitaxel products are all injectable with a lot of side effects and is inconvenience to use. Therefore, the development of oral paclitaxel formulations has always been a hot area in industry.

RMX3001 is originally developed by DAEHWA Pharma based on its innovative lipid self-emulsifying drug delivery technology. The product, with brand name Liporaxel, was successfully approved for launch for the treatment of gastric cancer by Korean Drug Administration (MFDS) on September 9, 2016. To date, Liporaxel is the world’s first successfully developed and approved oral paclitaxel. HaiHe Biopharma licensed in the rights of China mainland, Taiwan, Hong Kong and Thailand from DAEHWA Pharma in September 2017. HaiHe Biopharma actively advanced the IND filing process in China, with IND submission for gastric cancer in March 2018, and CTA granted in July 2018. It took only 4 months for CNDA review.