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Expedited clinical development strategies for China

Worth Sharing?

14 July 2021
WEBINAR

SCRIPT

Arsalan Arif: Hi, everyone. I’m Arsalan Arif, your host for today’s event on Expedited Clinical Development Strategies for China. We’re sponsored by Novotech, a leading Asia-Pacific biotech specialist CRO. For the audience, please submit your questions for today’s panellists using the Q&A box at the bottom of your screen. We’ve got a panel discussion coming up but first, I’m talking one-on-one with Yan Lu, the Director of Operational Strategy at PPC on China’s regulatory environment, a newly implemented breakthrough designation. Yan, tell us a bit more about your clinical experience and position at PPC?

Yan Lu: Sure. Hello everyone. My name is Yan Lu, Operational Strategy Lead from PPC. My major was Pharmaceutical Science and have a pharmacist licence. I started my career working as a CRA and then also served multiple roles across … management, project management, clinical operations and clinical science at CRO and pharmaceutical companies. 

Arsalan Arif: Can you talk us through China’s regulatory environment, Yan?

Yan Lu: Sure. First, I would like to walk through with you on the regulatory hierarchy on drug developments in China. On the top, it is drug administration law of People’s Republic of China, usually called DAL. DAL is the law, promulgated by National People’s Congress, first version on the year of 1984 and its latest revision is 2019. On the second layer is regulations for implementation of DAL, which is promulgated by the State Council, and the third layer is drug registration regulations, also called DRR for abbreviation, and this is promulgated by National Medical Product of Administration, which is also called NMPA for abbreviation. Under the revision of the CAL in 2019 following public consultation, the DRR is amended and newly implemented in July 2020. 

Arsalan Arif: Can you walk us through some of the highlights of the new drug regulatory registration, the DRR, especially the acceleration on registration procedures for drugs?

Yan Lu: From acceleration on drug registration procedures perspective I would like to highlight four regulatory pathways for drug approval which makes new treatments more readily available for the patients. The four pathways are: Breakthrough Therapy approval, conditional approval, priority review and approval, and special review and approval pathways. Special review and approval pathways could be applied throughout drug development and filing stage only for the drug developed for preventing or handling public health emergencies. For example, the drugs for COVID-19 treatment. 

The Breakthrough Therapy approval pathway and conditional approval pathway could be applied during clinical trials and then could apply for priority review and approval pathway at NDA or BLA filing. Priority review and approval pathway is only applicable for NDA with a shorter review timeline.

Arsalan Arif: When is the best time to apply for this breakthrough designation?

Yan Lu: As mentioned previously, application for a Breakthrough designation could be submitted during the clinical trial period, usually during Phase I or Phase II, no later than Phase III study initiation. I would say as earlier you apply for and be granted the designation, as much benefit you will receive.

Arsalan Arif: What are the key criteria that you have to meet to apply for this Breakthrough designation?

Yan Lu: The Breakthrough designation could be granted to the drug which is used to prevent and cure diseases that are severely life threatening or severely affect the quality of life and there is no effective prevention and control method, or compared with existing treatment there is sufficient evidence to show that innovative drugs or improved new drugs with obvious clinical advantage, these are the key criteria. 

Arsalan Arif: What kind of support will the CDE offer for these therapies with Breakthrough designations?

Yan Lu: CDE will mainly support from two aspects. One is CDE’s technical support, that is during the critical phase of a drug’s clinical trials. The Drug Evaluation Centre will prioritise allocation of resources for communication, strengthening guidance and CDE’s senior reviewers comprehensively discuss the research and … plan and related problems in content in drugs clinical pharmacology and toxicology, and so on. 

The other one is CDE’s process support. The feedback time for a project that has been identified as Breakthrough Therapy usually is no longer than 45 days to ensure that the review is more efficient. In addition, CDE provides comments or suggestions on the next research plan based on the submitted research data and will be included in a priority review and approval pathway at the filing stage.

Arsalan Arif: Tell us anything else we need to know for western companies that needs to know about this Breakthrough designation?

 

Yan Lu: I would like to highlight that for clinical trials of drugs that are included in the breakthrough drug program (1) it has found the conditions for inclusions that are no longer met, the applicant and the Drug Review Centre will promptly propose and have the right to terminate the breakthrough drug program.

Arsalan Arif: How many drugs have been granted this Breakthrough designation from CDE and can you tell us a little bit more about the therapeutic area?

Yan Lu: Sure. According to the data from NMPA, until May this year a total of 48 drugs that have been granted Breakthrough designations from NMPA. In terms of drug types, the number of antitumour drugs account for approximately 70 per cent of the total number. The second is anti-infection drugs, the third is immunology drugs. From the perspective of drug classifications, one-third of the total number are biological drugs, two-thirds are chemical drugs. The number of domestically … drugs is slightly more than imported drugs. Imported drugs was around 20, if I remember correctly.

Arsalan Arif: Let’s do a little bit of comparison here. Can you help compare China’s breakthrough pathway with the one that we have here in the US, so the FDA, is there a case study that you could highlight?

Yan Lu: Sure. First, with adding the breakthrough pathway comparison between China and United States I would like to share from four perspectives. First, regarding the timing of application submissions, in case of NMPA it is in the phase of Phase I and Phase II clinical trials, usually no later than the application before Phase III clinical trial initiation. On the other hand, in the case of FDA it is no longer than the end of Phase II meeting. 

Second, regarding the scope of application, in the case of NMPA it is used to prevent and treat life threatening or severely affecting the quality of survival and there is no effective means of prevention or treatment, or there is sufficient evidence to show that it has obvious clinical advantages compared with existing treatments. 

On the other hand, in the case of FDA it is used along or in combination with other drugs for the treatment of serious or life-threatening disease or conditions, and preliminary clinical evidence suggests that the drug may show substantial improvement compared to the existing therapies at one or more clinical significant endpoints. 

Third, regarding guidance on application feedback time from health authorities perspective, NMPA is a little shorter than that for FDA. NMPA’s feedback time is less or equal to 45 days. On the other hand, FDA’s feedback time is less or equal to 60 days.

Fourth, regarding special support from health authorities perspective, NMPA will offer communication during drug development, also put forward opinions on the next research plan or suggestion. In addition, after receiving Breakthrough designation, priority review and approval pathway is applicable. On the other hand, FDA offers more opportunities for communication and close guidance from FDA on drug development. FDA’s senior staff will participate in collaborative and interdisciplinary review and the fast track will be offered as well during review period, such as rolling review, priority review and so on.

For the case study regarding China Breakthrough designation, I would like to share the first case of overseas company receive the breakthrough designation. The target population was locally advanced or metastatic NSCLC patient with EGFR exon … insertion mutations who have received at least one systematic chemotherapy in the past. There was urgent clinical need and there was no (approval drug in the world for this indication. In US it was granted by FDA orphan drug designation in December 2019 and was granted Breakthrough designation by FDA in April 2020. In China it was applied for China Breakthrough designation in July 2020, as soon as the new DRR implemented, and was granted the designation in October 2020. From applications to receive the designation it took around three months. Currently this drug is under the breakthrough pathway for clinical development in both China and US.

Arsalan Arif: Looping back to the regulatory environment in general, … review. What ways does the NMPA actively support expedited clinical development, Yan?

Yan Lu: I would like to share from two aspects. Internally, CDE greatly increased human resources. CDE also introduced a PM role to enhance efficiency. In addition, CDE reviewers joined ICH EWG and facilitated knowledge exchange internationally. Externally, … previously NMPA implemented new regulations to support expedited clinical developments. For example, the fast track channels for drug approval and overseas clinical data acceptance, shortened IND review timeline and so on, and this point will be covered in the panel discussion session as well.

Arsalan Arif: Yan Lu, very informative and thank you for joining us today. 

Yan Lu: Thank you.

Arsalan Arif: Now we’re joined by a great panel of experts to continue in our discussion on Expedited Clinical Development Strategies for China, but before I move on to introductions I’d like to take this opportunity to introduce our sponsor. Novotech is a leading Asia-Pacific biotech specialist CRO with a fully integrated local subsidiary brand in China, PPC. Novotech is a full-service clinical CRO with labs, Phase I facilities and drug development consulting services. It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. 

Now for our panellists. First up I have Wenn Sun, the Founder and President of Precision Medicine Asia Incorporated. Next, Andy Liu, Managing Director of China, PPC CRO, and Dr Jian Zhang, Chief Physician (Oncology) and Deputy Director of Administration, Clinical Director of Phase I Centre at Fudan University Shanghai Cancer Centre. A quick reminder to the audience to submit your questions for the panel using the Q&A button at the bottom of your screen. We look forward to seeing what the audience has to say on today’s topic.

From here I give you Dr Jian Zhang. Dr Zhang?

Dr Jian Zhang: Hi, everybody. I’m from Fudan University Shanghai Cancer Centre. … Fudan University Shanghai Centre since its establishment in 1931 as the earliest specialised cancer hospital in China. Fudan University Shanghai Cancer Centre has now developed to be a grade-A tertiary hospital engaged in the integration of clinical practice, medical education, oncologic research and cancer prevention. Actually, the total number of clinical trials in this site is almost 1,000 between 2012 to 2021, and the number of beds at this site is 1,300, and the number of departments is 26 and number of employees is more than 2,000, including  more than 600 certified practitioners and more than 300 full and associate professors by the end of 2018. A number of research papers, … published as of ....

Also China accounts for a significant number of new cancer cases and it shows leadership in CAR-T cell development and, as we know, China accounted for almost 65 per cent of all CAR-T trials between 2015 and 2020. In 2020 there were 4.5 million new cancer cases in China. … analysis. This accounted for almost … of newly diagnosed cases and 30 per cent of the cancer-related deaths worldwide. Trials with a China component is almost 65 per cent and there’s very little without China involvement. 

Actually, China continues to show high patient recruitment rates. With patient recruitment rates from other parts of the world declining, the APAC region, that includes Australia, Hong Kong, Korea, New Zealand, Taiwan and Thailand, while excluding China and Japan, this region and China have shown strong resilience. The median patient recruitment rates across regions in 2019 and 2020 is shown as a figure … for the mono therapy and combination therapy trials respectively. Shows that in China and in Asia-Pacific the decline is very less and with strong resilience … the introduction of our site. 

Arsalan Arif: Thank you, Dr Jian Zhang. Next up we have Wenn Sun, the Founder and President of Precision Medicine Asia. Wenn, the floor is yours.

Wenn Sun: Thank you, Arsalan. Glad to be here to be part of this panel and talk about our experiences in China from the industry’s perspective. As Dr Zhang showed you some very interesting statistics and we actually, in one of the trials that we were involved in, had that experience of large patient recruitment from the China sites. Specifically, several years ago my company, OxOnc Development and Pfizer Oncology, we are engaged in the co-development with Xalkori ROS1 in non-small cell lung cancer, and this was an interesting trial and study in the way that the Asian data, including China, Japan, South Korea and Taiwan, were the only global registrational trials for the ROS1 indication and so we believe that this is the first case where a major indication was based on Asian trials, and then in that particular trial China contributed to almost 70 per cent of the patients.

This is several years back and I think in the last few years this trend has actually grown even bigger for China’s participation in both the number of trials and also number of patients that contribute to registrational study. This just points out to the importance of China as a country for development, clinical development of novel targeted therapy and also as a market by itself. 

In addition to the specific case of Xalkori’s development, we have also experienced in the region through developing a clinical genomic data platform, and currently there are 200 hospitals participating in Japan and we are planning to expand that platform to China with 25 hospitals. The audience are probably very aware of the novel targeted therapies development now requires sophisticated genomic screening and clinical data collation, and such a clinical genomic platform in Asia has become very important in terms of being able to identify the patient efficiently in a cost effective manner. They’re to help accelerate the clinical development and the regulatory approvals. In this particular type of platform we work with both pharmaceutical companies, as well as diagnostic companies, and a lot of these companies are US-based or from Europe and they are seeking entry into China for a faster and more efficient development. 

Most recently I joined the joint venture company initiated by Kinnate Biopharma based in San Francisco and Kinnate is an early stage company with a very robust pipeline, and the strategy for the company has been to engage Asia, especially China, in the early part of the development. Unlike in the older paradigms where the program may be brought to China out of Phase II, end of Phase II to join Phase III, I think more and more some of the biotech companies are looking at ways to enter China at a much earlier timepoint, which I think is wise given the disease differences, genomic differences, between the ethnic groups, and the learning and the quality of the sites have really propelled China ahead to be one of the key clinical development countries in the world.

As we talked about several years ago, the sequential strategy will be the typical ways to come into China after the development … its way in US or Europe and more and more now we’re seeing China-only strategies to allow parallel development or we see an integrated strategy where even at the of Phase I or pre-clinical stage the company starts to think about how to include China into the overall development plan. I am very happy that today this panel has highlighted this very important point and help some of the US companies and European companies to think about at what point of the development timeline we should put China into consideration, and how do we do that, and what are the practical and regulatory challenges and they need to be thought through, whether it’s the local partner to execute the trials or will the company be able to execute on its own.

I think there are many other topics that can be more expanded but I think today this webinar can at least highlight the importance and the critical nature of including China in its clinical development, and this is my last slide. Thank you, Arsalan.

Arsalan Arif: Thank you very much. Very helpful. Very helpful. Next up we have Andy Liu and Andy is the Managing Director for China for PPC CRO. Andy, the floor is yours now.

Andy Liu: Thanks, Arsalan. Hello everyone. Next I’m going to talk about how to accelerate entry into China and this is a very exciting topic. China has become one of the most important markets for leading biotechs, not only because it’s the world’s second largest pharmaceutical market, it’s also, I think, its large patient population, as Dr Zhang just mentioned, but also its large growing network of qualified investigative sites and the skilled clinical trial professionals, along with strong government support for international partnerships and through improved regulatory environment, altogether make the access to China possible, especially for western biotechs.

Here I probably want to share some of our experiences for leading biotechs to consider. How to accelerate their entries into China, taking the full advantage of China’s recent regulatory reforms and also improved overall ecosystem for the development of university trials. First of all, established in China between 2015-2017 MAH, Marketing Authorisation Holder system, removed the … between marketing and manufacturing of a trial. So that allowed R&D focused biotech to enter China without … their own manufacturing facility locally, which used to be a huge hurdle. MAH system not only encouraged players in the pharmaceutical industry to focus on their own strengths, for example biotechs for R&D, CMO for manufacturing, but also help significantly accelerate regulatory review and also following clinical development and the commercialisation. 

Second, China has been actively participating in global clinical trials for more than 10 years and developed a large group of experienced local biotechs, CROs and the research institutions. Western biotechs who probably don’t have much presence in China can partner with them and carry on clinical developments in China. Local partnerships will definitely remove a lot of preparation or learning time and help a western biotech to navigate smoothly in a totally new market and avoid pitfalls. 

Thirdly, Chinese regulator, I think AMPA, it used to be called CMPA, accepts overseas early phase clinical data to combat late stage trials or pivotal trials and also overseas pivotal trial data for … approval. Western biotechs have multiple entry points into China, as we mentioned, if they consider China early on in their global product development plan. … here probably similar as the … strategy and the sequential strategy … as I explained. A biotech can include China in Phase Ia/Ib or Phase Ia studies, in conjunction with countries facilitating rapid start-up or just start Phase I, for example, in Australia utilizes clinical trial data and seeking an approval over there to fast track approval for CTA filing in China and to initiate late-stage clinical trials here. Novotech CPC together have multiple successful stories, leveraging Australia to achieve First Patient In milestone quickly, while filing study in China to start up a couple of months later. This significantly reduces the overall clinical development timeline in China.

Also, overseas multi-region clinical trial data can be used for NDA applications as long as it covers … differences and accepts the CFDA’s inspection if it is needed. Of course, in theory, if your product is approved overseas in other countries or have Phase III data you can also directly file NDA in China but there’s a caveat. You’re already at this pathway, it’s probably just for those rare diseases or urgently ... Most of the time local data is still required.

Last but not least, to utilise we call “fast-track channels” for drug approval. There are four pathways … probably … in the application... Breakthrough Therapy designation, conditional approval, priority review and then special approval. You can take advantage of those fast-track approvals … for urgently needed drugs and definitely accelerate your entry into China market. So that’s my slide. Back to you, Arsalan.

Arsalan Arif: Thank you very much, Andy. Let’s get to some discussion questions now for the panel. Andy, actually let me just take it right back to you following up on your stuff. Can you talk us through some of the biggest advantages from the implementation of this Market Authorisation Holder system, the MAH system? Can you walk us through some of the biggest advantages?

Andy Liu: Sure. As I mentioned per slide, I think MAH system was started, I believe, in 2015 as a pilot just in probably 10 or 13 provinces, and officially later implemented across the country in 2017. I think a key change with this implementation is to no longer require those – the Marketing Authorisation Holder is not required to have a manufacturing facility by themselves in China, and that used to be a huge burden. Used to be a huge burden. So, under this new rule I believe a pharmaceutical company, a medical research institution or even CRO can be … MAH, provided that they are capable of managing the quality, so have these … systems to manage quality for the drug safety effectiveness and the quality in the whole process of drug development and production and later distribution.

I think that also gave the chance that different parties focus on different things. Like I mentioned, CMO, the Contract Manufacturing Organisation, they can focus on that, and the biotech, for example, like western biotech, they can just subcontract those kind of works for a CMO and they can focus on the … capability, research and development. I think another thing is in this system … applicants, they don’t even need to have their own team, they just need to find an enterprise legal person or even another party in China to help for the drug registration process. I think this also helps significantly shorten the review timeline and speed up the following development process. So I hope that answers your question?

Arsalan Arif: Yes, definitely. Now, let me follow up, Andy, and actually let me bring Dr Jian Zhang into this as well, I want to ask about the differences and the similarities or, really, probably the differences in site selection and management in general, maybe the disparity involving sites in China versus sites in the US and Europe. Can you give us a little bit of colour into that, please?

Andy Liu: Go, Jian Zhang, you want to start first? Sorry, go ahead.

Dr Jian Zhang: Okay. I think that’s a good question. Actually, China and Europe and the United States are equally willing to promote our studies so quality control of patient management in the research centre is basically homogenous and the management of some areas is better, I think. Due to the larger number of the patients, doctors have more clinical experience and better abilities to deal with some emergencies. The principles of GCP are generally followed. Of course there are not many innovative drugs in China local enterprises ... I think that more and more new drugs have been studied in China, so they have trained a number of research centres and researchers, so I think … involve a site in China, actually is equal to … Europe. That’s my answer. Thank you.

Arsalan Arif: Andy?

Andy Liu: Yeah. For this, I’d probably echo Dr Zhang, what Dr Zhang just explained. I think, first of all, China joined … in 2017 and adopted ICH-GCP guidelines to definitely align with the global standards, improve the quality, and also AMPA, starting in 2015, focused a lot on quality through those intensive study-based inspections.

Arsalan Arif: Let’s move on to the next question here. Dr Zhang, tell us about how your organisation facilitates clinical studies at Fudon University Shanghai Centre responses, especially, I understand, for biotech start-up companies?

Dr Jian Zhang: Okay. We have established an ethical pre-process and our research centre can provide … consultations between the … that provides IND Approval. At the same time, research institutions will speed up some administrative processes, especially for early phase drug research, especially for the international market centre research. At present there are more than 60 research Phase I studies in our cancer centre and more than 20 projects are under negotiations. We all feel that the process is smooth and the … is present. At the same time there are no delays in the process of enrolment. I think in our organisations, especially for the … cancer centre, has … facilitate, and try our best to facilitate the clinical study process, especially for the biotech start-up companies, I think. 

Arsalan Arif: Dr Zhang, how has the COVID situation been like in Shanghai?

Dr Jian Zhang: Actually, the COVID-19 has little … in Shanghai because there are no local new cases in Shanghai for several months. Only cases coming back from abroad. China, especially Shanghai, has done quite well in this respect, almost 90 per cent of the population is vaccinated. So it has little impact on clinical treatment activities and also in the study patient equivalence, I think.

Arsalan Arif: Very good. Wenn Sun, let’s talk about the regulatory pathways and the differences. Can you walk me through some of the biggest differences between these pathways in the US and China?

Wenn Sun: Sure. I think some regulatory challenges that all the companies face in China, I think more recently for us that is involved in the genomic medicine development, so there is a new regulation on the human genomic resources, so … RAC regulation, that’s been added, so for any clinical trials that use genomic information of patients’ samples then we have to go through that particular application to get approval, but I think in general China has made great strides in development in terms of shortening the development time, shorten the development time and, as I mentioned, talked about by the previous panel was about the accelerated approval equivalent to the Breakthrough designations, that’s definitely one way that some of the most innovative drugs have been able to go through that particular route.

In addition to that, there are still some requirements for having Chinese, ethnic Chinese patient data, in order for a trial to go into the Phase II development phase, but some of the data from overseas can still be leveraged. I think there are different alternatives to these regulatory requirements, but I personally think that in oncology, in cancer therapies, because most of the novel innovative drugs require genomic information for patient identification so some of the newest regulatory challenges or understanding will be around this human genetic information resources council’s requirement for the clinical trials in progress. 

Arsalan Arif: Thank you very much. Dr Zhang, let me return to you. Let’s talk about recruitment hurdles. What … does your centre face and how do you manage these challenges?

Dr Jian Zhang: I think the hurdles could be there in almost all sites. Recruitment … in our …also rare diseases recruitments as well, as when there are more competitive projects, .... But our centre will … each action through some cancer collaboration groups or study groups to recruit more patients. Recruit them also through some … announcements we’ve accrued more patients who are potentially interested in the research and this operation is relatively … at present. When there are more research projects we also think that we … actually as patients but when there are more projects as patients progress, have got better, disease from other projects can enter new studies when they are out of the … group. So more study groups is also a good situation, I think, especially for more than 50 studies in one centre, I think. This is my thoughts. Thank you.

Arsalan Arif: Andy, let’s talk about the NMPA’s special review channel. What does that support?

Andy Liu: Good question. That’s something NMPA set up to support some, we call, “good drugs” or “innovative drugs,” we call … drugs in China, that address … urgent needs, medical needs, like for public health or support drugs, rare disease, so called orphan drugs, products for paediatric population, and support products with obvious clinical advantage in China. But as I mentioned, there are four different channels, they have special rules under each. For example, Breakthrough Therapy designation had to be applied during clinical trial, no later than Phase III initiation. Prioritise communication needs to happen and conditional approval, I think, also eligible should be confirmed with authorities before NDA submission and post approval trial plan, like vertical timeline, needs to be communicated with the authority as well, and those going through the priority review and that … by national lists of drug in shortage kind of condition. So overall they can support needs for the patient in China and help to support fast forward moving those drugs in the pipeline and approval process.

Arsalan Arif: Thank you, Andy. It sounds as though there’s differences between partnering with a local biotech versus collaborating with a CRO, help us with that one.

Andy Liu: Yeah, that’s quite something I think that you need. Especially, I think, for a biotech company from western world because China even is attracting but there is also like a black ... Because they don’t have a lot of presence here they need to figure out how to get in the market and I think partnered with the local biotechs, I think include different modes, like joint ventures, a lot of in-licence and also licensing agreements, and even just marketing agreements in China. Personally, I think, based on our experience, we feel that is worthwhile for those small or medium sized companies. They have early stage product go through those developments in advance but they probably like the result, including capital, manpower and also, as I mentioned earlier, experience to do the development by themselves, and I think if you do have those kind of results of the, especially, funding … you can work with the CRO. I think that’s the difference, and collaborate to run the trial and go through the regulatory process. 

But I think that is something you need to consider. In that way you’re probably involving low risk in terms of you don’t need to negotiate, like, share in profit, like partner with the biotech because you’re sharing the rights, and also IP and commercial rights, something like that. So that’s the big difference, but it definitely depends each biotech’s own situation and they can choose based on their needs. I hope I answered your question?

Arsalan Arif: Yes, absolutely. Wenn, let’s talk about the data that’s coming from China. Do you have any concerns about that data being accepted by regulatory bodies of other regions, like in the US or Europe, or even concerns from investors or a big pharma partner?

Andy Liu: I mean, probably I can start? Go ahead, Winn. You start first, sorry.

Winn Sun: That’s a good question. I think data quality is always a challenge of any clinical trial in any country and I think that data from China is well accepted now in many of the registration trials. I think one of the examples I used during the slide presentation was the co-development, a program with Pfizer’s … Xalkori that actually the bulk of the data came out of China, that was a few years ago, and I think not only the data gained the China’s NMPA regulatory approval but because it was a regional study it was also used to support filing in Japan for PMDA approval, and I think the dataset was also very valuable in terms of the later on approval in other countries. I think that more and more we’re going to see that China-led studies will play a very significant role in regulatory approvals in other countries. 

Arsalan Arif: Very good. Andy, briefly?

Andy Liu: Yes, sorry. I fully agree. I think, first of all, as we mentioned earlier, the quality focus by the NMPA and they moved too close to the US or global centres in terms of the approval regulatory requirement, and also the overall improvement of the ecosystem, of the infrastructure we talk about, and also like Dr Zhang mentioned, the experience accumulated … by the industry in China definitely has improved quite a lot of the confidence and quality of the data, and we do have a lot of experience that will help the biotech company run the trials, including China, and have them successfully filed overseas as well. So I’m quite confident.

Arsalan Arif: Andy, we can get a study started up quickly, so that’s not an issue. What’s the biggest issue, the biggest challenge in conducting a study in China today?

Andy Liu: I guess, this talk about difference. I guess if we talk about from a western biotech’s perspective, even the reform significantly improved or shortened the timeline, starting timeline. In the past I remember five or six years ago, even to get to the CDA it takes 18 or 24 months. Right now it’s 60 days, working days, and actually it’s faster. But still, I think the challenge for the western companies, think about China, is first of all language and so everything, for me, the NMPA needs to simplify Chinese cultures and also it’s not just you know Chinese, it’s also the culture behind, how to work around with your partner. You enter the hospital – I mean, you … PI, that’s going to be a challenge. Regulatory timeline I mentioned, as I say, is shorter or fast but still longer compared with US and Australia, and I think there are still some gaps in terms of regulatory reform. For example, their data, like, (ACRAC they call Human Genetic Administration Committee. This kind of adds additional approving time for a trial to start and also importation licence, that gave another additional time a western biotech needs to consider how to start. 

Also, … I think another challenge is pricing policy. If you really want to get your product marketed in China … – that started a couple of years ago, volume-based procurement. So that gave additional pressure for western companies to consider when they plan to enter into China. I guess, if they have good partners they probably can help them smooth those and provide a lot of experience and the support how to move smoothly.

Arsalan Arif: Thank you. Thank you, Andy. Wenn, help us with this. You’re sitting here in the US right now, just like me, so from a US biotech perspective what do you feel’s the greatest advantage of adding sites in China offers to a global clinical program?

Wenn Sun: I would say that China has become such an important market from both development and commercial perspectives. It’s almost like you to be there, right, if you want to have a global program and, importantly, a footprint and so I think for the US biotech companies, one way or the other, I think they have to figure out what’s the best way for their company to engage China. I think the panel talked about you can have a licensing partner or you could actually – what we did with Kinnate, which is we formed a joint venture, that means the company will have a local footprint, right, and then I think there are some other factors in this micro or macro environment is they foster for the company to be able to go into China because the capital investors are very willing to now engage with such activities to provide the necessary funding for a US biotech to be able to enter China with their own team, and through the help of the CRO figure out the regulatory operational aspect of things but you still retain the control of your program, then you can sort of delay the partnering to a next value inflection point.

We see more and more of these type of business transactions being developed due to the availability of a new asset, the willingness to explore their options, the availabilities of the capital, and so it’s created a very dynamic environment for a US biotech to enter into China.

Arsalan Arif: Thank you. Great answer. We just have a few minutes left, so just a few questions I have for the panel remaining over here. Dr Zhang, I want to ask you about the cultural variations that are across China. So across China, how engaged are the public with clinical research? Are there certain key cities for investigators and patients that we should be aware of?

Dr Jian Zhang: I think although China is a multi-ethnic country, regional differences, the cultural variation, I think they maybe exist but there is no large differences in medical waiting lists. According to our statistics analysis, most of the participants in our survey, especially in our cancer centre and nearby provinces and all cities which are close by in geography, but not the cultural differences. We did not find the cultural differences leading to significant differences in willingness to join the studies. In fact, with promotion of clinical research people’s willingness to participate in clinical study has generally increased but investigators still need to do more explanation when they really visit. 

At present the key studies for investigators and patient recruitments are Shanghai, Beijing, Guangzhou, Chengdu and .... Now these are my thoughts for this ....

Arsalan Arif: Excellent. Thank you. Andy, I want to ask you quickly, if western biotechs are looking to partner with the local Chinese companies or CROs, what are the criteria they should be looking for, Andy?

Andy Liu: Sure. I guess, first of all, it’s local expertise, their experience. I mean, knowing the local well. So that’s including network … the investigators side, PI … and the relationship with regulators and also vendors. That’s critical. The second, I think, for the western biotech they need to find a partner. They can have same the same language. The partner needs to also have international …. So, consider what’s important for the western biotech and that’s also important. But as I mentioned, more and more Chinese … they joined before the international multi-regional clinical trials, so that’s something that’s building up.

The third one, definitely, is the expertise, especially ... I mean, the western biotech’s product, you need to find those partners with the experience and the knowledge for your product. The last one, I think, is the overall infrastructure and process which ensure they provide high standard services, ensure the quality, and not only just in China, it is for the global submission. So that’s a factor western biotech need to consider for a partner or CRO in China.

Arsalan Arif: Great. Well, I want to conclude this panel. Really excellent answers from everyone today, thank you very much, but I want to conclude with one final question and I would like everyone’s participation on the panel for this question. Andy, I would like to start with you and then I’m going to go to the rest of the panel. So if you were to supply just one piece of strategic advice to a western biotech looking to do trials in China, what would it be, Andy?

Andy Liu: I guess, this could be easy. You need to consider China earlier, when you start the overall planning because ask I explained, you have multiple things you can consider, take advantage, speed up, but if you consider China late you miss those options. Start early on, that would be my suggestion.

Arsalan Arif: Start early. Great. Thank you, Andy. Dr Zhang, what about you, what’s one piece of strategic advice to a western biotech who would like to conduct a trial in China?

Dr Jian Zhang: I think seeing this data and asking if you want to come to China for research, come as early as … and we will embrace you. Of course, it’s also a good choice to find a corporation partners, a CRO who is familiar with China’s policies and research centres, I think that is a good choice.

Arsalan Arif: Start early, find a partner. Finally, Wenn Sun, what is one piece of strategic advice for the western biotech looking to conduct a trial in China. Wenn?

Wenn Sun: I would say that the US company now they have to really look at the competitive landscape not just restricted to US any more. We used to look at the US company as competitors but I think the competitive landscape analysis, the research, that will have to be brought in to include China because there are also a lot of local companies engaged in innovative research and their innovative products, so not just from a clinical trial of your own …, early entry to China, I agree with Andy and Dr Zhang, is very important, which I share our experience with Kinnate. However, the other thing is really to also understand the competitive landscape within China.

Arsalan Arif: All right. Thank you very much. That is going to do it for our panel today. I want to thank everyone, Wenn Sun, Andy Liu and Dr Jian Zhang, and I also want to thank Novotech, a leading Asia-Pacific biotech specialist CRO. Thank you very much for another successful panel. Endpoints News, Arsalan Arif, and hope to see you again soon. Thanks, everybody.

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