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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 501 drug applications between 8 February 2023 and 14 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 137, covering 91 drug names.

2023/02/08 – 2023/02/14

Period
2023/02/08 to 2023/02/14, 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
501
Drugs with new generic filings (by drug name, de-duplicated)
91
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

501filings, 137 of them generic

By application type

Application typeFilings
Supplement210
Generic137
New drug94
Import24
Import re-registration19
Unspecified17

By drug type

Drug typeFilings
Chemical drug360
TCM75
Therapeutic biologic60
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

91 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules544
2Gadoteric Acid Meglumine Salt Injection511
3Urapidil Hydrochloride Injection426
4Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets413
5Levofloxacin Injection321
6Venlafaxine Hydrochloride Sustained-Release Capsules320
7Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation3112
8Piperacillin Sodium And Tazobactam Sodium For Injection315
9Metoprolol Succinate Extended-release Capsules314
10Sitagliptin Phosphate Tablets312

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

286 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Yunnan Shen Wei Shi Pu Rui Pharma Co., Ltd. romanized16160
2Name not romanized970
3CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD750
4Run Yuan Pharmaceutical Co., Ltd. romanized660
5Guangxi Yu Yuan Pharma Co., Ltd. romanized540
6Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized540
7Yi Chang Ren Fu Pharma Co., Ltd. romanized532
8Shandong Xin Shi Dai Pharma Co., Ltd. romanized535
9Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A510
10Hainan Pu Li Pharmaceutical Co., Ltd. romanized515

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

151 this week

AcceptedDrugApplicants
2023/02/14Import · Class 3.1 Ropeginterferon alfa-2b(P1101)注射液 · No verified English nameJXSS2300016 PharmaEssentia Corporation; PharmaEssentia Corporation Taichung Plant; PharmaEssentia Biotechnology (Beijing) Company limited
2023/02/14Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2300519 Suzhou Erye Pharmaceutical Co., Ltd
2023/02/14Generic · Class 3 Ibuprofen GranulesCYHS2300517 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2023/02/14Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300512 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300511 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300510 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Vancomycin Hydrochloride For Oral SolutionCYHS2300506 Jiangxi Qing Feng Pharma Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Vancomycin Hydrochloride For Oral SolutionCYHS2300505 Jiangxi Qing Feng Pharma Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 西他沙星细粒 · No verified English nameCYHS2300503 Ji Chuan Pharma Group Co., Ltd. romanized
2023/02/14Generic · Class 3 Peramivir InjectionCYHS2300502 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized; Yi Chang San Xia Pharmaceutical Co., Ltd. romanized
2023/02/14Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2300501 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2023/02/14Generic · Class 3 Peramivir InjectionCYHS2300500 Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized
2023/02/14Generic · Class 3 Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2300499 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2023/02/14Generic · Class 3 Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2300498 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2023/02/14Generic · Class 3 Levofloxacin InjectionCYHS2300493 Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized
2023/02/14Generic · Class 3 Bumetanide InjectionCYHS2300492 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2023/02/14Generic · Class 3 Granisetron Hydrochloride TabletsCYHS2300489 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2023/02/14New drug · Class 2.3; 2.2 A群C群脑膜炎球菌-b型流感嗜血杆菌(结合)联合疫苗 · No verified English nameCXSS2300006 Chengdu Ou Lin Bio Technology Co., Ltd. romanized
2023/02/14New drug · Class 1 GR2002注射液 · No verified English nameCXSL2300128 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/02/14New drug · Class 1 GR2002注射液 · No verified English nameCXSL2300127 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/02/14New drug · Class 1 GR2002注射液 · No verified English nameCXSL2300126 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2023/02/14New drug · Class 1 AK127注射液 · No verified English nameCXSL2300125 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/02/14New drug · Class 2.2 卡度尼利单抗注射液 · No verified English nameCXSL2300124 Kang Fang Pharma Co., Ltd. romanized
2023/02/14New drug · Class 1 GKL-006注射液 · No verified English nameCXSL2300123 Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized
2023/02/14New drug · Class 1 妥拉美替尼胶囊 · No verified English nameCXHS2300033 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized; Kang Long Hua Cheng (Ningbo) Technology Development Co., Ltd. romanized
2023/02/14New drug · Class 1 妥拉美替尼胶囊 · No verified English nameCXHS2300032 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized; Kang Long Hua Cheng (Ningbo) Technology Development Co., Ltd. romanized
2023/02/14New drug · Class 1 妥拉美替尼胶囊 · No verified English nameCXHS2300031 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized; Kang Long Hua Cheng (Ningbo) Technology Development Co., Ltd. romanized
2023/02/14New drug · Class 1 妥拉美替尼胶囊 · No verified English nameCXHS2300030 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized; Kang Long Hua Cheng (Ningbo) Technology Development Co., Ltd. romanized
2023/02/14New drug · Class 1 TQB3473片 · No verified English nameCXHL2300220 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/02/14New drug · Class 1 TQB3473片 · No verified English nameCXHL2300219 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD

121 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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