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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 390 drug applications between 10 September 2023 and 16 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 53 drug names.

2023/09/10 – 2023/09/16

Period
2023/09/10 to 2023/09/16, 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
390
Drugs with new generic filings (by drug name, de-duplicated)
53
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

390filings, 71 of them generic

By application type

Application typeFilings
Supplement201
Generic71
New drug71
Import24
Unspecified14
Import re-registration9

By drug type

Drug typeFilings
Chemical drug275
TCM61
Therapeutic biologic48
Prophylactic biologic6

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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Famotidine Injection428
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3323
3Vortioxetine Hydrobromide Tablets3210
4吸入用布地奈德混悬液 · No verified English name227
5利伐沙班颗粒 · No verified English name212
6Omeprazole and Sodium Bicarbonate Capsules210
7Pregabalin Oral Solution215
8Sacubitril Valsartan Sodium Tablets2170
9Oxacillin Sodium for Injection2113
10Loxoprofen Sodium Patches2130

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized14102
2Boehringer Ingelheim International GmbH1410
3Henan Yue Ren Pharma Co., Ltd. romanized12120
4Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
5Bard Pharmaceuticals Limited990
6Xian Jing Xi Shuang He Pharma Co., Ltd. romanized920
7Changchun Jin Sai Pharma Co., Ltd. romanized830
8Shanghai Bai Te Medical Yong Pin Co., Ltd. romanized610
9Guangdong Xin Bao Pharma Technology Co., Ltd. romanized550
10Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized550

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

125 this week

AcceptedDrugApplicants
2023/09/16Import · Class 2.4 米罗那非片 · No verified English nameJXHL2300226 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2023/09/16Import · Class 2.4 米罗那非片 · No verified English nameJXHL2300225 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2023/09/16Generic · Class 3 Famotidine InjectionCYHS2302501 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/09/16Generic · Class 3 Famotidine InjectionCYHS2302500 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/09/16Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2302498 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/09/16Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2302497 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/09/16New drug · Class 1 人源多巴胺能前体细胞注射液 · No verified English nameCXSL2300628 Rui Jian Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized; Wuhan Rui Jian Pharmaceuticals Technology Co., Ltd. romanized
2023/09/16New drug · Class 1 SKG0201注射液 · No verified English nameCXSL2300627 Lan Yue Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2023/09/16New drug · Class 1 SHR2554片 · No verified English nameCXHL2301008 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/16New drug · Class 1 SYH2053注射液 · No verified English nameCXHL2301007 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/09/15Import · Class 1 SAR442168 · No verified English nameJXHL2300224 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2023/09/15Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302491 Hai Men Pu Shi Pharmaceuticals Co., Ltd. romanized
2023/09/15Generic · Class 3 Dexketoprofen Trometamol InjectionCYHL2300118 Zhong Run Pharma Co., Ltd. romanized
2023/09/15Generic · Class 3 Arformoterol Tartrate Inhalation SolutionCYHL2300117 Jiangsu He Chen Pharma Co., Ltd. romanized
2023/09/15New drug · Class 2.3 菖麻熄风片 · No verified English nameCXZL2300061 Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized
2023/09/15New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2300626 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2023/09/15New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2300625 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2023/09/15New drug · Class 1 C-13-60细胞制剂 · No verified English nameCXSL2300624 Chongqing Jing Zhun Bio Technology Co., Ltd. romanized
2023/09/15New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2300623 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2023/09/15New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2300622 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2023/09/15New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2300621 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2023/09/15New drug · Class 1 MC-1-50细胞制剂 · No verified English nameCXSL2300620 Chongqing Jing Zhun Bio Technology Co., Ltd. romanized
2023/09/15New drug · Class 1 BGT-004胶囊 · No verified English nameCXHL2301006 Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2023/09/15New drug · Class 1 BGT-004胶囊 · No verified English nameCXHL2301005 Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2023/09/15New drug · Class 2.2; 2.4 依达拉奉右莰醇舌下片 · No verified English nameCXHL2301004 Xian Sheng Pharma Co., Ltd. romanized
2023/09/15New drug · Class 1 MN-08片 · No verified English nameCXHL2301003 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2023/09/14Generic · Class 3 Zoledronic Acid InjectionCYHS2302489 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/09/14Generic · Class 3 Isosorbide Oral SolutionCYHL2300116 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2023/09/14New drug · Class 2.2 聚乙二醇重组人生长激素注射液 · No verified English nameCXSS2300076 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/09/14New drug · Class 1 AK2017注射液 · No verified English nameCXSL2300619 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized

95 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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