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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 433 drug applications between 5 February 2023 and 11 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 126, covering 89 drug names.

2023/02/05 – 2023/02/11

Period
2023/02/05 to 2023/02/11, 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
433
Drugs with new generic filings (by drug name, de-duplicated)
89
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

433filings, 126 of them generic

By application type

Application typeFilings
Supplement184
Generic126
New drug77
Import19
Unspecified15
Import re-registration12

By drug type

Drug typeFilings
Chemical drug323
Therapeutic biologic55
TCM53
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

89 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules544
2Urapidil Hydrochloride Injection426
3Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets413
4Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
5Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation3112
6Piperacillin Sodium And Tazobactam Sodium For Injection315
7Sitagliptin Phosphate Tablets312
8Tadalafil Tablets2223
9Indobufen Tablets226
10Diquafosol Sodium Eye Drops225

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

261 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Yunnan Shen Wei Shi Pu Rui Pharma Co., Ltd. romanized15150
2Run Yuan Pharmaceutical Co., Ltd. romanized660
3Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized650
4Guangxi Yu Yuan Pharma Co., Ltd. romanized540
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD540
6Yi Chang Ren Fu Pharma Co., Ltd. romanized532
7Shandong Xin Shi Dai Pharma Co., Ltd. romanized535
8NAPP PHARMACEUTICALS LIMITED520
9Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A510
10Wu Hu Dao Run Pharma Co., Ltd. romanized440

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

127 this week

AcceptedDrugApplicants
2023/02/11Import · Class 2.2; 2.4 LYR-210系统 · No verified English nameJXHL2300022 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/02/11Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2300482 Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2023/02/11Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2300481 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/02/11Generic · Class 3 Amifostine For InjectionCYHS2300477 Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/02/11Generic · Class 3 Fudosteine oral solutionCYHS2300476 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2023/02/11Generic · Class 3 Potassium Chloride GranulesCYHS2300473 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/02/11Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300461 Sui Cheng Pharma Co., Ltd. romanized
2023/02/11Generic · Class 3 Epalrestat TabletsCYHS2300456 Beijing SL Pharmaceutical Co., Ltd.
2023/02/11Generic · Class 3 Lidocaine CataplasmsCYHS2300452 Hainan Hui Yuan Tang Pharma Co., Ltd. romanized
2023/02/11Generic · Class 3 Minoxidil Topical SolutionCYHS2300446 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Yunnan Kang En Bei Xi Tao Pharma Co., Ltd. romanized
2023/02/11Generic · Class 3 Minoxidil Topical SolutionCYHS2300445 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Yunnan Kang En Bei Xi Tao Pharma Co., Ltd. romanized
2023/02/11Generic · Class 3 Fluticasone Propionate CreamCYHS2300444 Fu Yuan Pharma Co., Ltd. romanized
2023/02/11Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2300437 Xizang Duo Rui Pharmaceuticals Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized
2023/02/11Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2300436 Xizang Duo Rui Pharmaceuticals Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized
2023/02/11Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2300435 Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2023/02/11Generic · Class 3 Cilostazol TabletsCYHS2300434 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2023/02/11Generic · Class 3 Diprophylline InjectionCYHS2300433 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/02/11Generic · Class 3 氟[18F]妥西吡注射液 · No verified English nameCYHL2300018 Beijing Xin He Pharmaceuticals Technology Co., Ltd. romanized
2023/02/11New drug · Class 3.1 苓桂术甘汤颗粒 · No verified English nameCXZS2300006 Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2023/02/11New drug · Class 1.1 消风宣窍颗粒 · No verified English nameCXZL2300010 Su Zhong Pharma Group Co., Ltd. romanized
2023/02/11New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2300120 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/02/11New drug · Class 1 注射用BL-M11D1 · No verified English nameCXSL2300119 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2023/02/11New drug · Class 1 注射用ZGGS15 · No verified English nameCXSL2300118 Name not romanized
2023/02/11New drug · Class 1 NM1F注射液 · No verified English nameCXSL2300117 Hefei Tian Gang Mian Yi Drug Co., Ltd. romanized
2023/02/11New drug · Class 1 注射用ASKG915 · No verified English nameCXSL2300116 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2023/02/11New drug · Class 1 AK112注射液 · No verified English nameCXSL2300115 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2023/02/11New drug · Class 1 AK127注射液 · No verified English nameCXSL2300114 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/02/11New drug · Class 1 信诺拉生酯胶囊 · No verified English nameCXHS2300027 Shanghai Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2023/02/11New drug · Class 2.2 左乙拉西坦缓释颗粒 · No verified English nameCXHS2300026 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2023/02/11New drug · Class 1 注射用盐酸ZG0895 · No verified English nameCXHL2300207 Name not romanized

97 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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