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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 262 drug applications between 25 September 2022 and 1 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 44 drug names.

2022/09/25 – 2022/10/01

Period
2022/09/25 to 2022/10/01, 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
262
Drugs with new generic filings (by drug name, de-duplicated)
44
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

262filings, 57 of them generic

By application type

Application typeFilings
Supplement137
Generic57
New drug44
Import11
Import re-registration7
Unspecified6

By drug type

Drug typeFilings
Chemical drug202
Therapeutic biologic37
TCM19
Biologic2
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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pentoxifylline Injection333
2Carbazochrome Sodium Sulfonate Injection311
3盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
4Aspirin Enteric-coated Tablets2210
5Allopurinol Tablets214
6Doxofylline Injection215
7Ornidazole Injection210
8Levocarnitine Injection214
9Doxycycline Hyclate for Injection2111
10Dopamine Hydrochloride Injection213

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

158 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized16100
2Beijing Ya Dong Biopharmaceutical Co., Ltd. romanized11110
3Henan Li Xin Pharmaceutical Co., Ltd. romanized920
4Chengdu Brilliant Pharmaceutical Co., Ltd.636
5NAPP PHARMACEUTICALS LIMITED610
6Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized550
7Hebei Chen Huan Bio Technology Co., Ltd. romanized440
8Wu Hu Dao Run Pharma Co., Ltd. romanized444
9Janssen Research & Development LLC420
10Hubei Min Kang Pharma Group Co., Ltd. romanized410

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

79 this week

AcceptedDrugApplicants
2022/10/01Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200178 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/01Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200177 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/01Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2200176 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/01Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2200296 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/01New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2200011 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/10/01New drug · Class 1 IBI343 · No verified English nameCXSL2200501 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/10/01New drug · Class 1 IBR733细胞注射液 · No verified English nameCXSL2200500 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2022/10/01New drug · Class 1 IBR733细胞注射液 · No verified English nameCXSL2200499 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2022/10/01New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠胶囊 · No verified English nameCXHS2200049 Xiamen En Cheng Pharmaceutical Co., Ltd. romanized
2022/10/01New drug · Class 1 TY705注射液 · No verified English nameCXHL2200752 Tianjin Drug Research Institute Co., Ltd. romanized
2022/10/01New drug · Class 1 TY705注射液 · No verified English nameCXHL2200751 Tianjin Drug Research Institute Co., Ltd. romanized
2022/09/30Import · Class 1 VAY736注射液 · No verified English nameJXSL2200175 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/09/30Import · Class 1 DS-1062a · No verified English nameJXSL2200174 ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited
2022/09/30Generic · Class 3 Ketorolac Trometamol TabletsCYHS2201655 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/09/30Generic · Class 3 Folic Acid TabletsCYHS2201652 Zhejiang Nord Pharmaceutical Co., Ltd
2022/09/30New drug · Class 3.4 人纤维蛋白粘合剂 · No verified English nameCXSL2200498 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2022/09/30New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2200497 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2022/09/30New drug · Class 1 RB0011注射液 · No verified English nameCXSL2200496 Rui Yang (Suzhou) Bio Technology Co., Ltd. romanized
2022/09/30New drug · Class 2.2 右布洛芬缓控释双层片 · No verified English nameCXHL2200750 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2022/09/30New drug · Class 2.2 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2200749 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2022/09/30New drug · Class 2.2 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2200748 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2022/09/30New drug · Class 1 Kylo-0603胶囊 · No verified English nameCXHL2200747 Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized
2022/09/30New drug · Class 1 Kylo-0603胶囊 · No verified English nameCXHL2200746 Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized
2022/09/29Import · Class 1 输注用无菌冻干粉Telisotuzumab vedotin · No verified English nameJXSL2200173 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai)Co. Ltd
2022/09/29Generic · Class 3 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2201647 Wu Hu Dao Run Pharma Co., Ltd. romanized
2022/09/29Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2201646 Wu Hu Dao Run Pharma Co., Ltd. romanized
2022/09/29Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2201644 Wu Hu Dao Run Pharma Co., Ltd. romanized
2022/09/29Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2201643 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized
2022/09/29Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2201642 Wu Hu Dao Run Pharma Co., Ltd. romanized
2022/09/29Generic · Class 3 Pentoxifylline InjectionCYHS2201641 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized

49 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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