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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 61 drug applications between 3 October 2022 and 9 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 16, covering 10 drug names.

2022/10/03 – 2022/10/09

Period
2022/10/03 to 2022/10/09, 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
61
Drugs with new generic filings (by drug name, de-duplicated)
10
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

61filings, 16 of them generic

By application type

Application typeFilings
Supplement26
New drug17
Generic16
Unspecified1
Import1

By drug type

Drug typeFilings
Chemical drug53
TCM4
Therapeutic biologic4

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

10 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops325
2Sodium Valproate Concentrated Solution for Injection210
3复方醋酸钠林格注射液 · No verified English name212
4Montelukast Sodium Chewable Tablets214
5Ondansetron Hydrochloride Injection215
6Compound Ipratropium Bromide Solution For Inhalation114
7Pregabalin Orally Disintegrating Tablets113
8Sildenafil Citrate Oral Disintegrating Tablets118
9Methocarbamol Injection113
10Cilostazol Tablets111

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

42 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Ling Yun Xian Pharmaceutical Co., Ltd. romanized330
2Henan Li Xin Pharmaceutical Co., Ltd. romanized310
3Janssen Research & Development LLC210
4Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized210
5Zhongshan Wanhan Pharmaceuticals Co., Ltd.212
6Beijing Liu Huan Pharma Co., Ltd. romanized210
7Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized212
8Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized210
9Shandong Lukang Pharmaceutical Co.,Ltd.210
10Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized212

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

25 this week

AcceptedDrugApplicants
2022/10/09Import · Class 1 Ritlecitinib胶囊 · No verified English nameJXHL2200297 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/10/09Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2201675 Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd.
2022/10/09Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2201674 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2022/10/09Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2201673 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2022/10/09Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2201670 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/10/09Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2201669 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/10/09New drug · Class 1 SAL008注射液 · No verified English nameCXSL2200503 Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/10/09New drug · Class 1 ALMB-0166注射液 · No verified English nameCXSL2200502 Shanghai En Le Mai Bio Technology Co., Ltd. romanized
2022/10/09New drug · Class 2.4 Pyrotinib Maleate TabletsCXHS2200053 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/10/09New drug · Class 2.4 Pyrotinib Maleate TabletsCXHS2200052 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/10/09New drug · Class 1 TL118颗粒 · No verified English nameCXHL2200763 Suzhou Tao Lve Bio Technology Co., Ltd. romanized
2022/10/09New drug · Class 1 BGM0504注射液 · No verified English nameCXHL2200762 Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized
2022/10/09New drug · Class 1 BGM0504注射液 · No verified English nameCXHL2200761 Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized
2022/10/09New drug · Class 1 CTS2016胶囊 · No verified English nameCXHL2200760 Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized
2022/10/09New drug · Class 1 CTS2016胶囊 · No verified English nameCXHL2200759 Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized
2022/10/09New drug · Class 1 氟[18F]纤抑素注射液 · No verified English nameCXHL2200758 Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized
2022/10/09New drug · Class 1 FZ002-037胶囊 · No verified English nameCXHL2200757 Guangzhou Fei Mi Zi Technology Co., Ltd. romanized
2022/10/09New drug · Class 1 FZ002-037胶囊 · No verified English nameCXHL2200756 Guangzhou Fei Mi Zi Technology Co., Ltd. romanized
2022/10/08Generic · Class 3 Cilostazol TabletsCYHS2201667 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/10/08Generic · Class 3 Methocarbamol InjectionCYHS2201665 Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/10/08New drug · Class 2.2; 2.4 盐酸右美托咪定鼻喷雾剂 · No verified English nameCXHS2200051 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/10/08New drug · Class 2.2; 2.4 盐酸右美托咪定鼻喷雾剂 · No verified English nameCXHS2200050 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/10/08New drug · Class 1 SPH4336片 · No verified English nameCXHL2200755 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2022/10/08New drug · Class 1 HN0190片 · No verified English nameCXHL2200754 Hui Nuo Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2022/10/08New drug · Class 1 HN0190片 · No verified English nameCXHL2200753 Hui Nuo Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized

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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