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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 354 drug applications between 7 July 2023 and 13 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 64 drug names.

2023/07/07 – 2023/07/13

Period
2023/07/07 to 2023/07/13, 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
354
Drugs with new generic filings (by drug name, de-duplicated)
64
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

354filings, 80 of them generic

By application type

Application typeFilings
Supplement173
Generic80
New drug67
Import17
Import re-registration13
Unspecified4

By drug type

Drug typeFilings
Chemical drug271
Therapeutic biologic39
TCM35
Prophylactic biologic9

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Oral Solution3211
2Oseltamivir Phosphate For Oral Suspension222
3Methocarbamol Injection223
4Carbazochrome Sodium Sulfonate Injection211
5复方奥美拉唑干混悬剂 · No verified English name210
6头孢羟氨苄片 · No verified English name210
7Oxcarbazepine Tablets214
8泊马度胺胶囊 · No verified English name214
9注射用头孢唑肟钠 · No verified English name214
10Oxacillin Sodium for Injection2113

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

213 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Brilliant Pharmaceutical Co., Ltd.1530
2AstraZeneca AB850
3Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized660
4Upjohn Manufacturing Ireland Unlimited Company610
5Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized532
6Intas Pharmaceuticals. Ltd.510
7Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized440
8An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized440
9Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized434
10Shenzhen Xin Li Tai Pharma Co., Ltd. romanized420

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

117 this week

AcceptedDrugApplicants
2023/07/13Import · Class 3.1 注射用泰朗妥昔单抗 · No verified English nameJXSS2300057 ADC Therapeutics SA; BSP Pharmaceuticals S.p.A.; Overland Pharmaceuticals (Shanghai) Co. Ltd.
2023/07/13Import · Class 1 Lu AF82422 注射液 · No verified English nameJXSL2300128 H. Lundbeck A/S
2023/07/13Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2301892 Hainan He Rui Pharmaceutical Co., Ltd. romanized
2023/07/13Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301889 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301888 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Famotidine InjectionCYHS2301883 Yunnan Xian Shi Pharma Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Sodium Nitroprusside InjectionCYHS2301878 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2300087 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2300086 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/07/13Generic · Class 3 Nelarabine injectionCYHL2300085 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/07/13New drug · Class 1.1 六黄止渴颗粒 · No verified English nameCXZL2300047 Guangdong Kai Zhong Bio Technology Co., Ltd. romanized
2023/07/13New drug · Class 1.2 复制缺陷型猴痘疫苗 · No verified English nameCXSL2300478 Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/07/13New drug · Class 3.3 QL2107注射液 · No verified English nameCXSL2300477 Qilu Pharmaceutical Co., Ltd.
2023/07/13New drug · Class 1 注射用TGI-6 · No verified English nameCXSL2300476 Hefei Tian Gang Mian Yi Drug Co., Ltd. romanized
2023/07/13New drug · Class 1 HT006.2.2滴眼液 · No verified English nameCXSL2300475 Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/07/13New drug · Class 1 HT006.2.2滴眼液 · No verified English nameCXSL2300474 Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/07/13New drug · Class 1 HT006.2.2滴眼液 · No verified English nameCXSL2300473 Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/07/13New drug · Class 1 HT006.2.2滴眼液 · No verified English nameCXSL2300472 Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/07/13New drug · Class 1 IBI363 · No verified English nameCXSL2300471 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/07/13New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2300470 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2023/07/13New drug · Class 2.4 植物源重组瑞替普酶 · No verified English nameCXSL2300468 Wuhan He Yuan Bio Technology Co., Ltd. romanized
2023/07/13New drug · Class 1 APGT-001片 · No verified English nameCXHL2300778 Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2023/07/13New drug · Class 1 APGT-001片 · No verified English nameCXHL2300777 Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2023/07/13New drug · Class 1 APGT-001片 · No verified English nameCXHL2300776 Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2023/07/13New drug · Class 1 甲苯磺酸艾贝司他片 · No verified English nameCXHL2300775 Xu Nuo Pharma (Nanjing) Co., Ltd. romanized
2023/07/13New drug · Class 1 SAL0120片 · No verified English nameCXHL2300774 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/07/13New drug · Class 1 SAL0120片 · No verified English nameCXHL2300773 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/07/13New drug · Class 1 HP007注射液 · No verified English nameCXHL2300772 Hua Pu Bio Technology (Hebei) Co., Ltd. romanized; Jiangsu Tai Pu Rui Bio Technology Co., Ltd. romanized
2023/07/12Import · Class 2.4 盐酸替纳帕诺片 · No verified English nameJXHS2300064 Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited
2023/07/12Import · Class 2.4 盐酸替纳帕诺片 · No verified English nameJXHS2300063 Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited

87 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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