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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 278 drug applications between 8 June 2023 and 14 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 52 drug names.

2023/06/08 – 2023/06/14

Period
2023/06/08 to 2023/06/14, 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
278
Drugs with new generic filings (by drug name, de-duplicated)
52
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

278filings, 70 of them generic

By application type

Application typeFilings
Supplement134
Generic70
New drug47
Unspecified12
Import11
Import re-registration4

By drug type

Drug typeFilings
Chemical drug197
TCM37
Therapeutic biologic33
Prophylactic biologic6
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution3134
2注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name312
3Potassium Chloride Injection2210
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
6地氯雷他定口服溶液 · No verified English name2126
7Levocarnitine Injection214
8Potassium Chloride Granules214
9Methotrexate Injection2111
10Urapidil Hydrochloride Injection216

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Brilliant Pharmaceutical Co., Ltd.522
2Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized440
3Sichuan Kelun Pharmaceutical Co., Ltd.434
4Qilu Pharmaceutical Co., Ltd.431
5Xin Dong Sheng Ji Co., Ltd. romanized410
6Zhejiang Ya Tai Pharma Co., Ltd. romanized410
7GlaxoSmithKline Biologicals SA330
8Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized330
9Guangdong Luo Fu Shan Ge Hong Pharmaceutical Co., Ltd. romanized330
10Guangxi Tai Nuo Pharmaceutical Co., Ltd. romanized330

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

81 this week

AcceptedDrugApplicants
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.
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 nameCYHS2301613 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/06/13Generic · Class 3 Methocarbamol InjectionCYHS2301612 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/06/13Generic · Class 3 Ornidazole InjectionCYHS2301608 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2023/06/13Generic · Class 3 Furosemide InjectionCYHS2301607 Wuhan Jiu An Pharma Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/06/13Generic · Class 3 Furosemide InjectionCYHS2301606 Wuhan Jiu An Pharma Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/06/13New drug · Class 1.3 马甲子胶囊 · No verified English nameCXZL2300040 Chengdu Ma Jia Zi Bio Technology Co., Ltd. romanized
2023/06/13New drug · Class 1 注射用SMP-656 · No verified English nameCXSL2300413 Chengdu Ke Ling Yuan Pharmaceuticals Technology Co., Ltd. romanized
2023/06/13New drug · Class 2.2 恩沃利单抗注射液 · No verified English nameCXSL2300412 Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized
2023/06/13New drug · Class 1 IBI355 · No verified English nameCXSL2300411 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/06/13New drug · Class 1 IBI355 · No verified English nameCXSL2300410 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/06/13New drug · Class 1 XNW21015片 · No verified English nameCXHL2300640 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/13New drug · Class 1 XNW21015片 · No verified English nameCXHL2300639 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/13New drug · Class 1 XNW21015片 · No verified English nameCXHL2300638 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/12New drug · Class 1.3 冻干人用CpG佐剂狂犬病疫苗(Vero细胞) · No verified English nameCXSL2300409 Changchun Zhuo Yi Bio Co., Ltd. romanized

51 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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