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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 264 drug applications between 9 June 2023 and 15 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 41 drug names.

2023/06/09 – 2023/06/15

Period
2023/06/09 to 2023/06/15, 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
264
Drugs with new generic filings (by drug name, de-duplicated)
41
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

264filings, 55 of them generic

By application type

Application typeFilings
Supplement132
Generic55
New drug46
Unspecified16
Import11
Import re-registration4

By drug type

Drug typeFilings
Chemical drug188
TCM38
Therapeutic biologic28
Biologic5
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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name312
2Empagliflozin Tablets2218
3Methocarbamol Injection223
4ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name210
5Furosemide Injection216
6Vonoprazan Fumarate Tablets2160
7Levocarnitine Injection214
8Potassium Chloride Granules214
9Perospirone Hydrochloride Tablets215
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

177 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized550
2Chengdu Brilliant Pharmaceutical Co., Ltd.522
3Sichuan Kelun Pharmaceutical Co., Ltd.434
4Xin Dong Sheng Ji Co., Ltd. romanized410
5Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized410
6Zhejiang Ya Tai Pharma Co., Ltd. romanized410
7Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized330
8Guangdong Luo Fu Shan Ge Hong Pharmaceutical Co., Ltd. romanized330
9Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized330
10Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized320

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

75 this week

AcceptedDrugApplicants
2023/06/15Import · Class 1 Obefazimod · No verified English nameJXHL2300139 ABIVAX S.A.; IQVIA RDS (Shanghai) Co. Ltd.
2023/06/15Import · Class 1 Obefazimod · No verified English nameJXHL2300138 ABIVAX S.A.; IQVIA RDS (Shanghai) Co. Ltd.
2023/06/15Generic · Class 3 Sodium Nitroprusside InjectionCYHS2301634 Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized
2023/06/15Generic · Class 3 Methocarbamol InjectionCYHS2301627 Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/06/15New drug · Class 2.3 百令胶囊 · No verified English nameCXZL2300041 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2023/06/15New drug · Class 1 注射用DB-1311 · No verified English nameCXSL2300418 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/06/15New drug · Class 1 CUD002注射液 · No verified English nameCXSL2300417 Sichuan Kang De Sai Medical Technology Co., Ltd. romanized
2023/06/15New drug · Class 2.2 水合氯醛口服溶液 · No verified English nameCXHS2300054 Chengdu Shuo De Pharma Co., Ltd. romanized
2023/06/15New drug · Class 2.2 水合氯醛口服溶液 · No verified English nameCXHS2300053 Chengdu Shuo De Pharma Co., Ltd. romanized
2023/06/15New drug · Class 2.2 MTS008缓释片 · No verified English nameCXHL2300650 Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized
2023/06/15New drug · Class 2.2 MTS008缓释片 · No verified English nameCXHL2300649 Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized
2023/06/15New drug · Class 2.2 MTS008缓释片 · No verified English nameCXHL2300648 Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized
2023/06/15New drug · Class 2.2 MTS008缓释片 · No verified English nameCXHL2300647 Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized
2023/06/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2300646 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized; Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2023/06/14Import · Class 1 盐酸伊普可泮胶囊 · No verified English nameJXHS2300050 Novartis Pharma Schweiz AG; Novartis Pharma Produktions GmbH; Beijing Novartis Pharma Co. Ltd.
2023/06/14Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂 · No verified English nameCYHS2301623 Hubei Bang Ze Pharmaceuticals Co., Ltd. romanized; Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized
2023/06/14Generic · Class 3 Potassium Aspartate InjectionCYHS2301622 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/06/14Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2301620 Fujian Tian Quan Pharma Co., Ltd. romanized
2023/06/14Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2301619 Fujian Tian Quan Pharma Co., Ltd. romanized
2023/06/14Generic · Class 3 Sodium Picosulfate Oral SolutionCYHL2300077 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized
2023/06/14New drug · Class 1 EI-001注射液 · No verified English nameCXSL2300416 An Li Xi Rong (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2023/06/14New drug · Class 1.1 肠道病毒71型-柯萨奇病毒A16型二价灭活疫苗(人二倍体细胞) · No verified English nameCXSL2300415 Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized
2023/06/14New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2300414 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/06/14New drug · Class 2.2 RHYK2008 · No verified English nameCXHL2300645 Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized
2023/06/14New drug · Class 2.2 RHYK2008 · No verified English nameCXHL2300644 Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized
2023/06/14New drug · Class 2.2 RHYK2008 · No verified English nameCXHL2300643 Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized
2023/06/14New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2300642 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/06/14New drug · Class 1 LN020干混悬剂 · No verified English nameCXHL2300641 Shandong Lu Ning Pharma Co., Ltd. romanized
2023/06/13Import · Class 1 STRO-002注射液(暂用) · No verified English nameJXSL2300106 Sutro Biopharma Inc.
2023/06/13Generic · Class 3 ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHS2301614 Sichuan Kelun Pharmaceutical Co., Ltd.

45 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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