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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 342 drug applications between 26 August 2023 and 1 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 62 drug names.

2023/08/26 – 2023/09/01

Period
2023/08/26 to 2023/09/01, 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
342
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
1

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

342filings, 82 of them generic

By application type

Application typeFilings
Supplement187
Generic82
New drug49
Import13
Unspecified8
Import re-registration3

By drug type

Drug typeFilings
Chemical drug227
TCM74
Therapeutic biologic35
Prophylactic biologic5
Biologic1

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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4223
2Potassium Chloride Injection3210
3Nicorandil for Injection321
4Lidocaine and Prilocaine Cream2224
5Lornoxicam for Injection222
6Moxifloxacin Hydrochloride Tablets2211
7腺苷钴胺胶囊 · No verified English name228
8Tacrolimus Ointment216
9Enzalutamide Tablets212
10Risperidone powder and solvent for depot suspension 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

199 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized32280
2Guizhou Rui He Pharmaceutical Co., Ltd. romanized23230
3Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized880
4Novartis Europharm Limited630
5Celgene Corporation610
6Sanofi-Aventis Deutschland GmbH550
7Merck Sharp & Dohme LLC420
8Hainan Brilliant Pharmaceutical Co., Ltd.421
9Qilu Pharmaceutical Co., Ltd.410
10AstraZeneca AB320

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

89 this week

AcceptedDrugApplicants
2023/09/01Import · Class 1 BI 765049 输注用粉末 · No verified English nameJXSL2300162 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/01Import · Class 1 AUP1602-C · No verified English nameJXSL2300161 Aurealis Therapeutics AG; Shenzhen Xbiome Biotech Co. Ltd.
2023/09/01Import · Class 2.2 Anifrolumab注射液 · No verified English nameJXSL2300160 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/09/01Generic · Class 3 Bumetanide InjectionCYHS2302349 Name not romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/09/01Generic · Class 3 Potassium Chloride InjectionCYHS2302346 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/09/01Generic · Class 3 Salbutamol Sulfate injectionCYHS2302342 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/09/01Generic · Class 3 Revefenacin inhalation solutionCYHL2300111 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2023/09/01New drug · Class 1 注射用RC108 · No verified English nameCXSL2300591 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/09/01New drug · Class 1 HB0025注射液 · No verified English nameCXSL2300590 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/09/01New drug · Class 1 HB0025注射液 · No verified English nameCXSL2300589 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/09/01New drug · Class 2.2 布地奈德福莫特罗吸入粉雾剂(胶囊型) · No verified English nameCXHL2300939 Zhuhai Rui Si Pu Li Pharmaceuticals Technology Co., Ltd. romanized
2023/09/01New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2300938 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/01New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2300937 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/01New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2300936 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/01New drug · Class 1 GS3-007a干混悬剂 · No verified English nameCXHL2300935 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/01New drug · Class 2.4 Neratinib Maleate TabletsCXHL2300934 Fu Kang (Shanghai) Health Technology Co., Ltd. romanized; Zhejiang Fu Kang Pharmaceutical Co., Ltd. romanized
2023/09/01New drug · Class 1 HZ-Q1070胶囊 · No verified English nameCXHL2300933 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Huan Bo Hai (Yan Tai) Drug Gao Deng Research Institute romanized
2023/08/31Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2300074 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2023/08/31Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2300073 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2023/08/31Generic · Class 3 Enzalutamide TabletsCYHS2302339 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/08/31Generic · Class 3 Enzalutamide TabletsCYHS2302338 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/08/31Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2302337 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Zhejiang Qian Yuan Hai Li Sheng Pharmaceutical Co., Ltd. romanized
2023/08/31Generic · Class 3 Epalrestat TabletsCYHS2302333 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2023/08/31Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302332 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/08/31Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2302331 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized
2023/08/31Generic · Class 3 Potassium Chloride GranulesCYHS2302326 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/08/31Generic · Class 3 Nicorandil for InjectionCYHS2302325 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/08/31Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2302323 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2023/08/31New drug · Class 1.1 麻星宣肺止咳贴 · No verified English nameCXZL2300056 Hubei You Er Sheng Pharma Co., Ltd. romanized
2023/08/31New drug · Class 1.1 麻星宣肺止咳贴 · No verified English nameCXZL2300055 Hubei You Er Sheng Pharma Co., Ltd. romanized

59 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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