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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 304 drug applications between 2 April 2026 and 8 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 31 drug names.

2026/04/02 – 2026/04/08

Period
2026/04/02 to 2026/04/08, 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
304
Drugs with new generic filings (by drug name, de-duplicated)
31
Accepted this week, now under review
78

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

304filings, 40 of them generic

By application type

Application typeFilings
Supplement200
Generic40
New drug37
Import16
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
TCM132
Chemical drug126
Therapeutic biologic41
Prophylactic biologic3
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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Arginine and Ibuprofen Granules3111
3Carboplatin Injection2110
4Diclofenac Diethylamine Emulgel2120
5Erythromycin Lactobionate for Injection2113
6Dexmethylphenidate Hydrochloride Exended-release Capsules212
7褪黑素颗粒 · No verified English name2112
8Acetylcysteine Injection1153
9Edaravone and Dexborneol Concentrated Solution for Injection1134
10Celecoxib Capsules115

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
1Hubei Tai Zi Pharma Co., Ltd. romanized12120
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1250
3Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized10100
4Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized870
5Merck Sharp & Dohme B.V.820
6Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized610
7Novo Nordisk A/S530
8Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Er Factory romanized440
9Name not romanized430
10Shandong Feng Huang Pharmaceutical Co., Ltd. romanized430

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

61 this week

AcceptedDrugApplicants
2026/04/08Generic · Class 3 Potassium Chloride GranulesCYHS2600797 Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized
2026/04/08Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2600795 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/04/08Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2600794 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/04/08Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHS2600793 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized
2026/04/08Generic · Class 3 Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2600792 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/04/08Generic · Class 3 Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2600791 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/04/08New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2600383 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/04/08New drug · Class 1 HCL001 细胞注射液 · No verified English nameCXSL2600382 Shanghai Hui Cun Medical Technology Co., Ltd. romanized
2026/04/08New drug · Class 1 泽普昔替尼胶囊 · No verified English nameCXHS2600049 Ling Ke Pharma (Zhejiang) Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2026/04/08New drug · Class 2.2; 2.4 富马酸伏诺拉生氯化钠注射液 · No verified English nameCXHS2600048 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2026/04/08New drug · Class 1 PC-0120片 · No verified English nameCXHL2600420 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2026/04/08New drug · Class 1 HSK46256片 · No verified English nameCXHL2600419 Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2026/04/08New drug · Class 1 HSK46256片 · No verified English nameCXHL2600418 Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2026/04/08New drug · Class 1 VVD-133214 片 · No verified English nameCXHL2600417 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2026/04/08New drug · Class 1 VVD-133214 片 · No verified English nameCXHL2600416 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2026/04/08New drug · Class 1 VVD-133214 片 · No verified English nameCXHL2600415 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2026/04/08New drug · Class 1 VVD-133214 片 · No verified English nameCXHL2600412 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2026/04/08New drug · Class 1 VVD-133214 片 · No verified English nameCXHL2600411 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2026/04/08New drug · Class 1 VVD-133214 片 · No verified English nameCXHL2600410 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2026/04/07Generic · Class 3 盐酸他喷他多口服溶液 · No verified English nameCYHL2600038 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/04/07New drug · Class 1 SYS6041 · No verified English nameCXSL2600381 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/04/07New drug · Class 1 ANS02胶囊 · No verified English nameCXHL2600414 Beijing An Shi Bio Technology Co., Ltd. romanized
2026/04/07New drug · Class 1 ANS02胶囊 · No verified English nameCXHL2600413 Beijing An Shi Bio Technology Co., Ltd. romanized
2026/04/07New drug · Class 1 68Ga-NYM096注射液制备用药盒 · No verified English nameCXHL2600409 Anhui Nuo Yu Biopharmaceutical Co., Ltd. romanized
2026/04/07New drug · Class 1 LT-010391片 · No verified English nameCXHL2600408 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
2026/04/07New drug · Class 1 LT-010391片 · No verified English nameCXHL2600407 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
2026/04/04Import · Class 2.2 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600031 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 2.2 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600030 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600029 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/04/04Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600028 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd

31 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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