YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 394 drug applications between 12 July 2023 and 18 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 52 drug names.
2023/07/12 – 2023/07/18
- New acceptances this week
- 394
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
394filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 74 |
| New drug | 60 |
| Import | 34 |
| Import re-registration | 22 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 289 |
| Therapeutic biologic | 50 |
| TCM | 47 |
| Prophylactic biologic | 7 |
| In vitro diagnostic reagent | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vortioxetine Hydrobromide Tablets | 4 | 2 | 10 |
| 2 | Sodium Hyaluronate Eye Drops | 3 | 2 | 30 |
| 3 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 4 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 5 | 氧 · No verified English name | 2 | 2 | 15 |
| 6 | 瑞巴派特片 · No verified English name | 2 | 2 | 4 |
| 7 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 8 | Acetylcysteine Granules | 2 | 1 | 4 |
| 9 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 10 | Indobufen Tablets | 2 | 1 | 6 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
224 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 32 | 23 | 0 |
| 2 | AstraZeneca AB | 13 | 4 | 0 |
| 3 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 6 | 4 | 0 |
| 6 | Upjohn Manufacturing Ireland Unlimited Company | 6 | 1 | 0 |
| 7 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Intas Pharmaceuticals. Ltd. | 5 | 1 | 0 |
| 9 | Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Roche Pharma (Schweiz) AG | 4 | 2 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/18Import · Class 1 | HFB200301注射液 · No verified English nameJXSL2300130 | HiFiBiO Inc.; HiFiBiO (Hangzhou) Co. Ltd |
| 2023/07/18Import · Class 1 | AZD9833片 · No verified English nameJXHL2300170 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2023/07/18Import · Class 1 | 瑞普替尼胶囊 · No verified English nameJXHL2300169 | Bristol-Myers Squibb Company |
| 2023/07/18Import · Class 1 | 瑞普替尼胶囊 · No verified English nameJXHL2300168 | Bristol-Myers Squibb Company |
| 2023/07/18Import · Class 1 | INCB099280片 · No verified English nameJXHL2300167 | Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd. |
| 2023/07/18Generic · Class 3 | Lidocaine Hydrochloride Topical SolutionCYHS2301936 | Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/07/18Generic · Class 3 | Scopolamine Butylbromide InjectionCYHS2301935 | Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/07/18Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2301932 | Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2023/07/18Generic · Class 3 | Diprophylline InjectionCYHS2301931 | Fujian Tian Quan Pharma Co., Ltd. romanized |
| 2023/07/18Generic · Class 3 | Indobufen TabletsCYHS2301929 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2023/07/18Generic · Class 3 | Indobufen TabletsCYHS2301928 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2023/07/18Generic · Class 3 | Multiple Vitamins InjectionCYHS2301923 | Shandong Lu Sheng Pharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2023/07/18Generic · Class 3 | Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2300088 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized |
| 2023/07/18New drug · Class 3.1 | 一贯煎颗粒 · No verified English nameCXZS2300014 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | AK0610注射液 · No verified English nameCXSL2300492 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | KL-A167注射液 · No verified English nameCXSL2300491 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | 注射用SKB264 · No verified English nameCXSL2300490 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | K1注射液 · No verified English nameCXSL2300488 | Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | K1注射液 · No verified English nameCXSL2300487 | Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized |
| 2023/07/18New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2300486 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | LX-132胶囊 · No verified English nameCXHL2300794 | Guangzhou Li Xin Bio Technology Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | LX-132胶囊 · No verified English nameCXHL2300793 | Guangzhou Li Xin Bio Technology Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | SC0011片 · No verified English nameCXHL2300792 | Wuxi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | GT1708F片 · No verified English nameCXHL2300791 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2023/07/18New drug · Class 1 | GT1708F片 · No verified English nameCXHL2300790 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2023/07/17Import · Class 1 | AZD9833片 · No verified English nameJXHL2300166 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2023/07/17Import · Class 1 | AZD5305 · No verified English nameJXHL2300165 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/07/17Import · Class 1 | AZD5305 · No verified English nameJXHL2300164 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/07/17Import · Class 1 | AZD5305 · No verified English nameJXHL2300163 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/07/17Import · Class 1 | AZD5305 · No verified English nameJXHL2300162 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
81 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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