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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 295 drug applications between 13 October 2022 and 19 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 51 drug names.

2022/10/13 – 2022/10/19

Period
2022/10/13 to 2022/10/19, 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
295
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

295filings, 65 of them generic

By application type

Application typeFilings
Supplement160
Generic65
New drug36
Unspecified13
Import13
Import re-registration8

By drug type

Drug typeFilings
Chemical drug221
TCM35
Therapeutic biologic27
Biologic9
Prophylactic biologic3

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丁酸氯维地平注射用乳剂 · No verified English name210
5复方醋酸钠林格注射液 · No verified English name212
6Ibuprofen Injection218
7Paliperidone Extend-release Tablets212
8Potassium Chloride Granules214
9Piperacillin Sodium And Tazobactam Sodium For Injection215
10Decitabine For Injection210

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

171 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Di Tai Pharmaceutical Co., Ltd. romanized13110
2Hainan Pharmaceutical Factory Co., Ltd. Wuhan Branch romanized10100
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
6Beng Bu Hong Ye Pharma Co., Ltd. romanized550
7Novo Nordisk A/S520
8Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized440
9Hubei Mei Lin Pharma Co., Ltd. romanized440
10AbbVie Inc.420

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

80 this week

AcceptedDrugApplicants
2022/10/19Import · Class 1 Modakafusp Alfa注射液(TAK-573) · No verified English nameJXSL2200184 Takeda Development Center Americas Inc.; Takeda(China) International Trading Co. Ltd
2022/10/19Generic · Class 3 脑脊髓手术用洗净灌流液 · No verified English nameCYHS2201776 Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized
2022/10/19Generic · Class 3 Amisulpride Oral SolutionCYHS2201774 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2022/10/19Generic · Class 3 Pentoxifylline InjectionCYHS2201773 Jiangxi He Ying Pharma Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2022/10/19Generic · Class 3 Nicorandil for InjectionCYHS2201772 Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized
2022/10/19Generic · Class 3 Ibuprofen InjectionCYHS2201770 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2022/10/19Generic · Class 3 Ibuprofen InjectionCYHS2201769 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2022/10/19New drug · Class 1 PD-1基因编辑T细胞注射液 · No verified English nameCXSL2200524 Chengdu Mei Jie Sai Er Bio Technology Co., Ltd. romanized
2022/10/19New drug · Class 1 9MW3011注射液 · No verified English nameCXSL2200523 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2022/10/19New drug · Class 1 9MW3011注射液 · No verified English nameCXSL2200522 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2022/10/19New drug · Class 1 DXC009 · No verified English nameCXSL2200521 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2022/10/18Generic · Class 3 Colesevelam Hydrochloride TabletsCYHS2201768 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized
2022/10/18Generic · Class 3 Peramivir InjectionCYHS2201764 Suzhou Ai Mei Jin Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2022/10/18Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2201762 Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized
2022/10/18Generic · Class 3 Furosemide InjectionCYHS2201761 Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
2022/10/18Generic · Class 3 Memantine Hydrochloride Sustained-release CapsulesCYHS2201759 Jewim Pharmaceutical (Shandong) Co., Ltd.
2022/10/18Generic · Class 3 Memantine Hydrochloride Sustained-release CapsulesCYHS2201758 Jewim Pharmaceutical (Shandong) Co., Ltd.
2022/10/18Generic · Class 3 Acetaminophen InjectionCYHS2201756 Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
2022/10/18Generic · Class 3 瑞巴派特片 · No verified English nameCYHS2201755 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized
2022/10/18Generic · Class 3 Azilsartan TabletsCYHS2201753 Di Sha Pharma Group Co., Ltd. romanized
2022/10/18New drug · Class 1 泽沃基奥仑赛注射液 · No verified English nameCXSS2200084 Kai Xing Sheng Ming Technology (Shanghai) Co., Ltd. romanized; Shanghai Ke Ji Pharmaceutical Co., Ltd. romanized
2022/10/18New drug · Class 1 靶向Survivin DC细胞注射液 · No verified English nameCXSL2200520 Qi Chen Sheng Bio Technology (Zhuhai) Co., Ltd. romanized
2022/10/18New drug · Class 1 HY2195片 · No verified English nameCXHL2200812 Heng Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2022/10/18New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHL2200811 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2022/10/18New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHL2200810 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2022/10/18New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHL2200809 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2022/10/18New drug · Class 1 FCN-437c胶囊 · No verified English nameCXHL2200808 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2022/10/18New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2200807 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2022/10/18New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2200806 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2022/10/18New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2200805 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized

50 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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