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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 279 drug applications between 10 June 2023 and 16 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 47 drug names.

2023/06/10 – 2023/06/16

Period
2023/06/10 to 2023/06/16, 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
279
Drugs with new generic filings (by drug name, de-duplicated)
47
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

279filings, 62 of them generic

By application type

Application typeFilings
Supplement130
Generic62
New drug49
Import19
Unspecified15
Import re-registration4

By drug type

Drug typeFilings
Chemical drug198
TCM42
Therapeutic biologic31
Biologic4
Prophylactic biologic4

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
1Ethyl Iosapentate Capsules2227
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
9Procaterol Hydrochloride Oral Solution2112
10Perospirone Hydrochloride Tablets215

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

185 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen Research & Development LLC550
2Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized550
3An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized550
4Sichuan Kelun Pharmaceutical Co., Ltd.545
5Xin Dong Sheng Ji Co., Ltd. romanized410
6Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized410
7Zhejiang Ya Tai Pharma Co., Ltd. romanized410
8Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized330
9Guangdong Luo Fu Shan Ge Hong Pharmaceutical Co., Ltd. romanized330
10Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) 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

93 this week

AcceptedDrugApplicants
2023/06/16Import · Class 1 MEDI5752 · No verified English nameJXSL2300110 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/06/16Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2300109 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 2.3 Guselkumab/Golimumab(JNJ-78934804)注射液 · No verified English nameJXSL2300108 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 2.2 戈利木单抗注射液 · No verified English nameJXSL2300107 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 1 LOXO-783片 · No verified English nameJXHL2300143 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/06/16Import · Class 1 LOXO-783片 · No verified English nameJXHL2300142 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/06/16Import · Class 1 RO7435846片 · No verified English nameJXHL2300141 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/06/16Import · Class 1 RO7435846片 · No verified English nameJXHL2300140 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/06/16Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301644 Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized
2023/06/16Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301643 Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized
2023/06/16Generic · Class 3 Diprophylline InjectionCYHS2301642 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2023/06/16Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301639 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/06/16Generic · Class 3 Furosemide Oral SolutionCYHS2301638 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/06/16Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2301636 Guangdong Wen Jian Pharma Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2023/06/16Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2301635 Guangdong Wen Jian Pharma Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2023/06/16New drug · Class 1 UBT251注射液 · No verified English nameCXHL2300655 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2023/06/16New drug · Class 2.2; 2.4 DA001滴眼液 · No verified English nameCXHL2300654 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized
2023/06/16New drug · Class 2.2; 2.4 DA001滴眼液 · No verified English nameCXHL2300653 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized
2023/06/16New drug · Class 2.2; 2.4 DA001滴眼液 · No verified English nameCXHL2300652 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized
2023/06/16New drug · Class 2.2 异福酰胺分散片 · No verified English nameCXHL2300651 Zhejiang Su Ke An Pharma Co., Ltd. romanized
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

63 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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