YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 606 drug applications between 4 June 2026 and 10 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 77 drug names.

2026/06/04 – 2026/06/10

Period
2026/06/04 to 2026/06/10, 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
606
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
173

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

606filings, 114 of them generic

By application type

Application typeFilings
Supplement335
Generic114
New drug96
Import46
Unspecified8
Import re-registration7

By drug type

Drug typeFilings
Chemical drug298
TCM214
Therapeutic biologic89
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

77 drugs with new generic filings; top 10 listed

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

350 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized19140
2Eli Lilly and Company1930
3Novo Nordisk A/S1520
4Jiangsu En Hua Pharma Co., Ltd. romanized833
5Eli Lilly Nederland B.V.810
6Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized730
7Jiangsu Hao Sen Pharma Group Co., Ltd. romanized720
8Celgene Corporation a Bristol-Myers Squibb Company610
9Chengdu Hua Sen Ao Rui Pharma Co., Ltd. romanized610
10Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized550

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

181 this week

AcceptedDrugApplicants
2026/06/10Import · Class 2.4 Apalutamide TabletsJXHS2600061 Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLC; Xian Janssen Pharmaceutical Ltd.
2026/06/10Import · Class 2.4 BYL719 · No verified English nameJXHL2600214 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/06/10Import · Class 2.4 BYL719 · No verified English nameJXHL2600213 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/06/10Import · Class 2.4 奥氟格列隆钙片 · No verified English nameJXHL2600212 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/06/10Import · Class 2.4 奥氟格列隆钙片 · No verified English nameJXHL2600211 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/06/10Import · Class 2.4 奥氟格列隆钙片 · No verified English nameJXHL2600210 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/06/10Import · Class 2.4 奥氟格列隆钙片 · No verified English nameJXHL2600209 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/06/10Import · Class 2.4 奥氟格列隆钙片 · No verified English nameJXHL2600208 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/06/10Import · Class 2.4 奥氟格列隆钙片 · No verified English nameJXHL2600207 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/06/10Generic · Class 3 Lidocaine Hydrochloride Ophthalmic GelCYHS2601374 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/06/10Generic · Class 3 Triamcinolone Acetonide and Econazole Nitrate CreamCYHS2601373 Fu Yuan Pharma Co., Ltd. romanized
2026/06/10Generic · Class 3 Triamcinolone Acetonide and Econazole Nitrate CreamCYHS2601372 Fu Yuan Pharma Co., Ltd. romanized
2026/06/10Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601362 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/06/10Generic · Class 3 Pirfenidone TabletsCYHS2601361 Chengdu Brilliant Pharmaceutical Co., Ltd.
2026/06/10Generic · Class 3 氨基酸(15)腹膜透析液 · No verified English nameCYHS2601360 Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/06/10Generic · Class 3 氨基酸(15)腹膜透析液 · No verified English nameCYHS2601359 Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/06/10Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601358 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2026/06/10Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601357 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2026/06/10New drug · Class 2.3 西帕依固龈液 · No verified English nameCXZL2600055 Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized; Qi Mu (Guangdong Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized
2026/06/10New drug · Class 1 SCTA02A注射液 · No verified English nameCXSL2600627 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/06/10New drug · Class 1 注射用TQB6426 · No verified English nameCXSL2600626 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/06/10New drug · Class 1 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2600625 Tian Mai Yuan He Biopharmaceuticals (Changchun) Co., Ltd. romanized
2026/06/10New drug · Class 1 SK10胶囊 · No verified English nameCXSL2600624 Guangzhou Zhi Yi Bio Technology Co., Ltd. romanized
2026/06/10New drug · Class 1 注射用HBM7004 · No verified English nameCXSL2600623 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/06/10New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSL2600621 Kun Shan Xin Yun Da Bio Technology Co., Ltd. romanized
2026/06/10New drug · Class 1 靶向间皮素嵌合抗原受体NK细胞注射液 · No verified English nameCXSL2600620 Guo Jian Yi Nuo Bio Technology (Beijing) Co., Ltd. romanized
2026/06/10New drug · Class 1 DY1133滴眼剂 · No verified English nameCXSL2600618 Xiamen Hong Guan Bio Technology Co., Ltd. romanized
2026/06/10New drug · Class 1 HS-10568注射液 · No verified English nameCXHS2600085 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/06/10New drug · Class 1 HRS-1597片 · No verified English nameCXHL2600692 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/06/10New drug · Class 1 HRS-1597片 · No verified English nameCXHL2600691 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized

151 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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