Digg It - Business

Companies pursuing an increased presence in China have had a wide of results. Small and mid-size USA companies have had tremendous success in China creating great value for their customers, employees and shareholders. Other USA firms have struggled or failed to get resu

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

lts in China.

Small and mid-size USA firms are expanding their business with China to be close to their customers in the China, and to take advantage of favorable cost and financial incentives for doing business in China. The following key success factors must be managed

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

to have successful business venture in China.

Realistic Business Expectations – Avoid Frustrating Mistakes! USA fast paced business expectations can create frustrating negotiations and unrealistic initial goals for ventures in China. Chinese negotiators use ti

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e more deliberately during business negotiations than is typical in the USA.

In addition to normal business factors, the influence of various Chinese governmental agencies and different legal requirements can affect the timing of projects and realization of results. Ha

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ving a head-start with a local Chinese ally can provide support sorting through bureaucratic and cultural barriers.

Chinese Perspective – Navigating through Rapidly Changing Environment!

Visiting China for face-to-face meetings with local business partners and potential

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

customers is important to gain both market knowledge and perspective on doing business China. It can also start the process of developing key personal “Guanxi” relationships.

It’s not unusual for USA firms to consider legal agreements as the perquisite for conducting bu

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

siness. In China, it is much more common to consider personal relationships a perquisite to establishing binding legal agreements and business relationships. Understanding Chinese cultural and business practices can avoid damaging mistakes.

Personal Relationships (“

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

Guanxi”) – Critical to Success! Developing strong personal relationships with Chinese customers and partners is part of Chinese business culture on how to get results in China. These relationships can months or years to develop, and can be accelerated by the sele

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

tion of the right local Chinese partner.

Establishing a strong relationship is critical and can be more important than any legal agreement. This is true of business partners, employees, customers, and suppliers as well as governmental agencies. Key Chinese government a

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

gencies still have a major influence on businesses operating in China. Directly and with local partners, USA firms need to establish these Chinese “Guanxi” relationships in addition to more traditional business activity.

Market Knowledge – Essential to Achieving

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

oals and Plans! To ensure a successful venture into China, small and mid-size USA firms should thoroughly understand the external and internal market factors in China, have well defined strategic and implementation China plan, and solicit support of local business part

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ners to avoid start-up risks. Chinese markets and operation can be complex. However, there is significant data available from private and government sources on China marketing and operating opportunities. Professional investigation of various market and operational dev

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

elopments in China, familiarizing yourself with different aspects of Chinese law, and deciding on a partnership, merger or an acquisition that may be appropriate for your business is essential to achieving results.

Implementation Plans – Relentless Focus on Result

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

! The importance of aligning Chinese deployment plans with long-term targets in China is similar to the need for business alignment in the USA.

The key to a successful business in China is an overall Chinese strategy, policy, implementation plans and performance goals t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

hat are updated on a continuous basis. It is important to understand where your business has been, where it is now in China, and where it needs to be in the future.

There can be implementation obstacles that are unfamiliar to small USA business leaders, such as, special

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

logistics and transportation issues, currency issues, taxation issues, and other governmental factors. So, an independent view from China can be vital for a clear, fresh and objective assessment of business strategy, policy, performance, and potential in China.

There is

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

an explosion of Chinese business partners assisting USA firms do business in China. As a result, there are professional Chinese partners to help develop and implement your plans in China. Once the key elements of your Chinese deployment plans are defined and deployed, r

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

egular business reviews will keep your plan on track to success.

Call to Action Summary – Make your move to China! USA Custom data shows that trade with China is increasing over 20% per year. USA imports from China have reached over $200 billion with USA exports

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

to China approaching $50 billion.

A significant portion of this trade with China is increasingly coming from small to mid-size companies which are driving higher growth with customers in the China, and are taking advantage of favorable cost and financial incentives for d

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

oing business in China to improve profitable performance.

The keys to successfully doing business in China are not a mystery and business risks are manageable with a China business development plan based on solid market knowledge and insight into China’s business culture

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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