YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 252 drug applications between 6 October 2022 and 12 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 47 drug names.

2022/10/06 – 2022/10/12

Period
2022/10/06 to 2022/10/12, 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
252
Drugs with new generic filings (by drug name, de-duplicated)
47
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

252filings, 61 of them generic

By application type

Application typeFilings
Supplement115
Generic61
New drug54
Import re-registration16
Import5
Unspecified1

By drug type

Drug typeFilings
Chemical drug190
Therapeutic biologic29
TCM28
Prophylactic 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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops325
2Sodium Valproate Concentrated Solution for Injection210
3复方醋酸钠林格注射液 · No verified English name212
4Montelukast Sodium Chewable Tablets214
5Vonoprazan Fumarate Tablets2160
6Torsemide Injection211
7Telmisartan Tablets214
8Meropenem for Injection215
9Ondansetron Hydrochloride Injection215
10Sitagliptin Phosphate Tablets212

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

168 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Haerbin Jun An Tang Pharmaceuticals Co., Ltd. romanized770
2AstraZeneca UK Limited710
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
4Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.410
5Guangxi Ling Yun Xian Pharmaceutical Co., Ltd. romanized330
6Jiangsu Mei Tian Pharma Co., Ltd. romanized330
7Qilu Pharmaceutical Co., Ltd.332
8Zhongshan Wanhan Pharmaceuticals Co., Ltd.323
9Bracco Imaging Italia s.r.l.310
10Changzhou Heng Bang Pharma Co., Ltd. romanized310

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

85 this week

AcceptedDrugApplicants
2022/10/12Import · Class 1 CB-5339 胶囊 · No verified English nameJXHL2200299 Cleave Therapeutics Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2022/10/12Import · Class 1 CB-5339 胶囊 · No verified English nameJXHL2200298 Cleave Therapeutics Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2022/10/12Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201719 Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized
2022/10/12Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201718 Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized
2022/10/12Generic · Class 3 Compound α-Ketoacid TabletsCYHS2201716 Shanghai Zhi Jian Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized
2022/10/12Generic · Class 3 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English nameCYHS2201713 Sichuan Kelun Pharmaceutical Co., Ltd.
2022/10/12Generic · Class 3 Calcium Acetate Oral SolutionCYHS2201712 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2022/10/12Generic · Class 3 钠钾镁钙葡萄糖注射液 · No verified English nameCYHS2201707 Yi Chang Ren Fu Pharma Co., Ltd. romanized; Yi Chang San Xia Pharmaceutical Co., Ltd. romanized
2022/10/12Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2201703 Chongqing Huapont Pharmaceutical Co., Ltd.
2022/10/12New drug · Class 1.1 小儿二白止痛颗粒 · No verified English nameCXZL2200046 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2022/10/12New drug · Class 3.3 冻干A群C群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2200510 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2022/10/12New drug · Class 1 C66胶囊 · No verified English nameCXHL2200790 Wen Zhou Yi Ke University romanized
2022/10/12New drug · Class 1 HS-10390片 · No verified English nameCXHL2200789 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2022/10/12New drug · Class 1 HS-10390片 · No verified English nameCXHL2200788 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2022/10/12New drug · Class 1 VVN461滴眼液 · No verified English nameCXHL2200787 Wei Mou Bio Technology (Shanghai) Co., Ltd. romanized
2022/10/12New drug · Class 1 VVN461滴眼液 · No verified English nameCXHL2200786 Wei Mou Bio Technology (Shanghai) Co., Ltd. romanized
2022/10/12New drug · Class 1 VVN461滴眼液 · No verified English nameCXHL2200785 Wei Mou Bio Technology (Shanghai) Co., Ltd. romanized
2022/10/12New drug · Class 1 HS-10390片 · No verified English nameCXHL2200784 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2022/10/12New drug · Class 1 注射用DN015089 · No verified English nameCXHL2200783 Shanghai Di Nuo Pharmaceuticals Technology Co., Ltd. romanized
2022/10/12New drug · Class 1 SYH2043片 · No verified English nameCXHL2200782 CSPC OUYI PHARMACEUTICAL CO., LTD.
2022/10/12New drug · Class 1 SYH2043片 · No verified English nameCXHL2200781 CSPC OUYI PHARMACEUTICAL CO., LTD.
2022/10/12New drug · Class 2.2 注射用LN003 · No verified English nameCXHL2200780 Shanghai Hui Yong Drug Research Co., Ltd. romanized
2022/10/11Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2201702 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/10/11Generic · Class 3 Salbutamol Sulfate injectionCYHS2201696 Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2022/10/11Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2201695 Qilu Pharmaceutical Co., Ltd.; Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2022/10/11Generic · Class 3 Potassium Chloride GranulesCYHS2201694 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2022/10/11Generic · Class 3 Pentoxifylline InjectionCYHS2201692 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2022/10/11Generic · Class 3 Potassium Aspartate And Magnesium Aspartate InjectionCYHS2201691 Yang Pu Jing Tai Pharma Co., Ltd. romanized; Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2022/10/11Generic · Class 3 Potassium Aspartate And Magnesium Aspartate InjectionCYHS2201690 Yang Pu Jing Tai Pharma Co., Ltd. romanized; Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2022/10/11New drug · Class 1 人源化神经生长因子抗体注射液 · No verified English nameCXSL2200509 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized

55 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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