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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 288 drug applications between 14 October 2022 and 20 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 51 drug names.

2022/10/14 – 2022/10/20

Period
2022/10/14 to 2022/10/20, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
288
Drugs with new generic filings (by drug name, de-duplicated)
51
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

288filings, 64 of them generic

By application type

Application typeFilings
Supplement137
Generic64
New drug55
Unspecified15
Import13
Import re-registration4

By drug type

Drug typeFilings
Chemical drug201
Therapeutic biologic38
TCM37
Biologic10
Prophylactic biologic2

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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oseltamivir Phosphate Capsules3139
2Peramivir Injection227
3Glycopyrronium Bromide and Neostigmine Metilsulfate Injection223
4复方醋酸钠林格注射液 · No verified English name212
5Ibuprofen Injection218
6Paliperidone Extend-release Tablets212
7Amisulpride Injection211
8Potassium Chloride Granules214
9Rosuvastatin Calcium Tablets2118
10Memantine Hydrochloride Sustained-release Capsules212

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

160 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Di Tai Pharmaceutical Co., Ltd. romanized13110
2Novo Nordisk A/S1030
3Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized990
4Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized710
5Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized660
6Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized610
7Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized550
8Beng Bu Hong Ye Pharma Co., Ltd. romanized550
9Ren He Yi Kang Group Co., Ltd. romanized532
10Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized520

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

97 this week

AcceptedDrugApplicants
2022/10/20Import · Class 1 GSK3228836 注射液 · No verified English nameJXHL2200306 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD
2022/10/20Generic · Class 3 Minoxidil Topical SolutionCYHS2201785 Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2022/10/20Generic · Class 3 Minoxidil Topical SolutionCYHS2201784 Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2022/10/20Generic · Class 3 盐酸丙卡特罗片 · No verified English nameCYHS2201781 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2022/10/20Generic · Class 3 Amisulpride InjectionCYHL2200096 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2022/10/20Generic · Class 3 Amisulpride InjectionCYHL2200095 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2022/10/20Generic · Class 3 Dexketoprofen Trometamol InjectionCYHL2200094 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/10/20New drug · Class 2.3 左金胶囊 · No verified English nameCXZL2200047 Wen Zhou Hai He Pharma Co., Ltd. romanized
2022/10/20New drug · Class 1 6MW3211 注射液 · No verified English nameCXSL2200536 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2022/10/20New drug · Class 3.3 长效重组人促红素注射液 · No verified English nameCXSL2200535 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized
2022/10/20New drug · Class 3.3 长效重组人促红素注射液 · No verified English nameCXSL2200534 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized
2022/10/20New drug · Class 3.3 长效重组人促红素注射液 · No verified English nameCXSL2200533 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized
2022/10/20New drug · Class 3.3 长效重组人促红素注射液 · No verified English nameCXSL2200532 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized
2022/10/20New drug · Class 3.3 长效重组人促红素注射液 · No verified English nameCXSL2200531 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized
2022/10/20New drug · Class 3.3 长效重组人促红素注射液 · No verified English nameCXSL2200530 Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized
2022/10/20New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2200529 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/10/20New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2200528 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/10/20New drug · Class 1 注射用奥拉奇西普 · No verified English nameCXSL2200527 Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized
2022/10/20New drug · Class 1 Y101D · No verified English nameCXSL2200526 Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized
2022/10/20New drug · Class 1.4 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2200525 Shanghai Rui Zhou Bio Technology Co., Ltd. romanized; Changchun Rui Zhou Biopharmaceutical Co., Ltd. romanized
2022/10/20New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHS2200057 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/10/20New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHS2200056 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/10/20New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHS2200055 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/10/20New drug · Class 1 FCN-016滴眼液 · No verified English nameCXHL2200823 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2022/10/20New drug · Class 1 FCN-016滴眼液 · No verified English nameCXHL2200822 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2022/10/20New drug · Class 1 FCN-016滴眼液 · No verified English nameCXHL2200821 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2022/10/20New drug · Class 1 AZD4205胶囊 · No verified English nameCXHL2200820 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2022/10/20New drug · Class 1 AZD4205胶囊 · No verified English nameCXHL2200819 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2022/10/20New drug · Class 1 AZD4205胶囊 · No verified English nameCXHL2200818 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2022/10/20New drug · Class 1 DZD9008片 · No verified English nameCXHL2200817 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized

67 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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