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
- 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 type | Filings |
|---|---|
| Supplement | 335 |
| Generic | 114 |
| New drug | 96 |
| Import | 46 |
| Unspecified | 8 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 298 |
| TCM | 214 |
| Therapeutic biologic | 89 |
| Prophylactic biologic | 3 |
| Biologic | 2 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 6 | 3 | 55 |
| 2 | Nafamostat Mesilate for Injection | 4 | 3 | 38 |
| 3 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 4 | Landiolol Hydrochloride for Injection | 3 | 3 | 19 |
| 5 | Pregabalin Orally Disintegrating Tablets | 3 | 1 | 3 |
| 6 | Rotigotine Patches | 3 | 1 | 7 |
| 7 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 8 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 9 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 10 | Dapagliflozin Tablets | 2 | 2 | 84 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 19 | 14 | 0 |
| 2 | Eli Lilly and Company | 19 | 3 | 0 |
| 3 | Novo Nordisk A/S | 15 | 2 | 0 |
| 4 | Jiangsu En Hua Pharma Co., Ltd. romanized | 8 | 3 | 3 |
| 5 | Eli Lilly Nederland B.V. | 8 | 1 | 0 |
| 6 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 7 | 3 | 0 |
| 7 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 7 | 2 | 0 |
| 8 | Celgene Corporation a Bristol-Myers Squibb Company | 6 | 1 | 0 |
| 9 | Chengdu Hua Sen Ao Rui Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 5 | 5 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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