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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 228 drug applications between 27 March 2025 and 2 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 33 drug names.

2025/03/27 – 2025/04/02

Period
2025/03/27 to 2025/04/02, 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
228
Drugs with new generic filings (by drug name, de-duplicated)
33
Accepted this week, now under review
18

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

228filings, 49 of them generic

By application type

Application typeFilings
Supplement120
Generic49
New drug37
Import17
Import re-registration3
Unspecified1
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug156
TCM36
Therapeutic biologic33
Prophylactic biologic3

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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Upadacitinib Sustained-release Tablets3143
2Paliperidone Palmitate Injection318
3Polidocanol Injection3123
4Ferrous Succinate Tablets2220
5Glucosamine Sulfate Capsules2251
6维生素B6注射液 · No verified English name2210
7Famotidine Injection218
8Famciclovir Tablets210
9Flomoxef Sodium for Injection219
10Ropivacaine hydrochloride injection215

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

133 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized990
2Shenyang Dong Xin Pharma Co., Ltd. romanized850
3Eli Lilly and Company720
4Novo Nordisk A/S610
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
6Hunan Jiudian Pharmaceutical Co., Ltd441
7Jin He Zang Yao Co., Ltd. romanized430
8Henan Pu Rui Pharma Co., Ltd. romanized424
9Hunan Xian Shi Pharmaceutical Co., Ltd. romanized421
10Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410

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

73 this week

AcceptedDrugApplicants
2025/04/02Import · Class 1 Clesrovimab注射液 · No verified English nameJXSS2500042 Merck Sharp & Dohme B.V.; Patheon Manufacturing Services LLC; MSD R&D (China) Co. Ltd.
2025/04/01Generic · Class 3 Famciclovir TabletsCYHS2501240 Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized
2025/04/01Generic · Class 3 Famciclovir TabletsCYHS2501239 Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized
2025/04/01Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2501237 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2025/04/01Generic · Class 3 Haloperidol Oral SolutionCYHS2501233 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2025/04/01New drug · Class 1 注射用SHR-A1904 · No verified English nameCXSL2500258 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/04/01New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500257 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/04/01New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2500256 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/04/01New drug · Class 1 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2500255 Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2025/04/01New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2500254 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/04/01New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2500253 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/04/01New drug · Class 1 SHR2554片 · No verified English nameCXHL2500347 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/04/01New drug · Class 1 SNH-119014片 · No verified English nameCXHL2500346 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2025/04/01New drug · Class 1 SNH-119014片 · No verified English nameCXHL2500345 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2025/04/01New drug · Class 1 SNH-119014片 · No verified English nameCXHL2500344 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2025/03/31New drug · Class 1 爱可仑赛注射液 · No verified English nameCXSS2500039 Beijing Yong Tai Bio Zhi Pin Co., Ltd. romanized
2025/03/29Generic · Class 3 Trimebutine Maleate TabletsCYHS2501232 Zhejiang Dong Ya Pharma Co., Ltd. romanized
2025/03/29Generic · Class 3 Trimebutine Maleate TabletsCYHS2501231 Zhejiang Dong Ya Pharma Co., Ltd. romanized
2025/03/29Generic · Class 3 厄贝沙坦氨氯地平片(III) · No verified English nameCYHS2501230 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2025/03/29Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501229 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/03/29Generic · Class 3 厄贝沙坦氨氯地平片(I) · No verified English nameCYHS2501228 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2025/03/29Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2501227 Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/03/29Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2501226 Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/03/29New drug · Class 2.2 AKZ002直服颗粒 · No verified English nameCXHL2500343 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/03/28Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500038 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/28Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500037 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/28Import · Class 1 Empasiprubart注射用浓溶液 · No verified English nameJXSL2500047 argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd.
2025/03/28Import · Class 1 PF-07985045片 · No verified English nameJXHL2500066 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/03/28Import · Class 1 PF-07985045片 · No verified English nameJXHL2500065 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500064 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

43 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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