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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 432 drug applications between 12 July 2024 and 18 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 138, covering 88 drug names.

2024/07/12 – 2024/07/18

Period
2024/07/12 to 2024/07/18, 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
432
Drugs with new generic filings (by drug name, de-duplicated)
88
Accepted this week, now under review
3

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

432filings, 138 of them generic

By application type

Application typeFilings
Supplement177
Generic138
New drug59
Import28
Import re-registration18
Unspecified12

By drug type

Drug typeFilings
Chemical drug277
TCM70
Therapeutic biologic69
Prophylactic biologic11
Biologic5

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

88 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets10431
2Febuxostat Tablets6312
3Bumetanide Injection5313
4二甲硅油乳剂 · No verified English name5214
5Carbazochrome Sodium Sulfonate Injection321
6Brexpiprazole Orally Disintegrating Tablets3110
7恩那度司他片 · No verified English name310
8Nicorandil for Injection311
9Cariprazine hydrochloride Capsules313
10Calcium Folinate Injection224

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

273 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized1080
2Qilu Pharmaceutical Co., Ltd.737
3Nitto Denko Corporation610
4Merck Sharp & Dohme LLC540
5Hebei Tian Cheng Pharma Co., Ltd. romanized540
6Shandong Qidu Pharmaceutical Co., Ltd.525
7Novo Nordisk A/S510
8Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized440
9Suzhou Lang Ke Bio Technology Co., Ltd. romanized434
10Bristol-Myers Squibb Pharma EEIG420

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

141 this week

AcceptedDrugApplicants
2024/07/18Import · Class 1 巴托利单抗注射液 · No verified English nameJXSS2400060 DRAGON MERIT HOLDINGS LIMITED; Samsung Biologics Co. Ltd.; Nuo Na Bio (Suzhou) Co., Ltd. romanized
2024/07/18Import · Class 2.6 重组呼吸道合胞病毒(RSV)疫苗(AS01E 佐剂系统) · No verified English nameJXSL2400126 GlaxoSmithKline Biologicals SA; GlaxoSmithKline (China) Investment Co. Ltd.
2024/07/18Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2402252 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2402251 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2402250 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2402247 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2402246 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Amisulpride InjectionCYHS2402245 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/07/18Generic · Class 3 Amisulpride InjectionCYHS2402244 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/07/18Generic · Class 3 Piperacillin Sodium for InjectionCYHS2402242 Wuhan Heng Tai Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Piperacillin Sodium for InjectionCYHS2402241 Wuhan Heng Tai Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2402236 Qilu Pharmaceutical Co., Ltd.
2024/07/18Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2402235 Qilu Pharmaceutical Co., Ltd.
2024/07/18Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2402234 Qilu Pharmaceutical Co., Ltd.
2024/07/18Generic · Class 3 Bumetanide InjectionCYHS2402233 Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/07/18Generic · Class 3 Bumetanide InjectionCYHS2402232 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/07/18Generic · Class 3 Bumetanide InjectionCYHS2402231 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/07/18Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2402222 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2402217 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2024/07/18Generic · Class 3 Diprophylline InjectionCYHS2402216 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/07/18Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2402214 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2024/07/18Generic · Class 3 枸橼酸苯海拉明布洛芬片 · No verified English nameCYHL2400152 Hefei En Rui Te Pharma Co., Ltd. romanized
2024/07/18Generic · Class 3 Azithromycin Eye DropsCYHL2400151 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2024/07/18New drug · Class 3.2 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSS2400074 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/07/18New drug · Class 3.2 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSS2400073 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/07/18New drug · Class 3.2 注射用A型肉毒毒素 · No verified English nameCXSS2400072 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2024/07/18New drug · Class 3.2 注射用A型肉毒毒素 · No verified English nameCXSS2400071 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2024/07/18New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2400070 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2024/07/18New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2400069 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2024/07/18New drug · Class 1 IVB103注射液 · No verified English nameCXSL2400464 Beijing Nuo Wei Biopharmaceuticals Technology Co., Ltd. romanized

111 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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