YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 345 drug applications between 16 January 2026 and 22 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 56 drug names.
2026/01/16 – 2026/01/22
- New acceptances this week
- 345
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 89
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
345filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 72 |
| New drug | 72 |
| Import | 39 |
| Unspecified | 10 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| Therapeutic biologic | 82 |
| TCM | 55 |
| Prophylactic biologic | 2 |
| Biologic | 1 |
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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 2 | Mirogabalin Besilate Tablets | 3 | 1 | 61 |
| 3 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 4 | Deferasirox Tablets | 2 | 1 | 3 |
| 5 | 头孢呋辛酯干混悬剂 · No verified English name | 2 | 1 | 5 |
| 6 | Nimodipine Oral Solution | 2 | 1 | 4 |
| 7 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 2 | 1 | 12 |
| 8 | Bromhexine Hydrochloride Oral Solution | 2 | 1 | 22 |
| 9 | 维立西呱片 · No verified English name | 2 | 1 | 8 |
| 10 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 12 | 1 | 0 |
| 2 | Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin (Han Zhong) Co., Ltd. romanized | 9 | 7 | 0 |
| 3 | Kashima Plant Eisai Co. Ltd. | 6 | 6 | 0 |
| 4 | Novartis Europharm Limited | 6 | 2 | 0 |
| 5 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 4 | 4 | 1 |
| 7 | Boehringer Ingelheim International GmbH | 4 | 3 | 0 |
| 8 | F. Hoffmann-La Roche Ltd | 4 | 3 | 0 |
| 9 | Pfizer Inc. | 4 | 3 | 0 |
| 10 | Amgen Inc. | 4 | 2 | 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
130 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/22Import · Class 2.2 | 马塔西单抗注射液 · No verified English nameJXSS2600005 | Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd. |
| 2026/01/22Import · Class 2.4 | LOU064片 · No verified English nameJXHL2600026 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/22Import · Class 2.4 | LOU064片 · No verified English nameJXHL2600025 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/22Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2600256 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
| 2026/01/22Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2600255 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
| 2026/01/22Generic · Class 3 | Nimodipine Oral SolutionCYHS2600251 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2026/01/22Generic · Class 3 | Nimodipine Oral SolutionCYHS2600250 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2026/01/22New drug · Class 1.1 | 参灵颗粒 · No verified English nameCXZL2600010 | Zhejiang Zuo Li Pharma Co., Ltd. romanized |
| 2026/01/22New drug · Class 1.2 | 障复康胶囊 · No verified English nameCXZL2600009 | Gan Jiang Xin Qu Ai Ze Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/22New drug · Class 1.2 | 木蝴蝶总黄酮提取物 · No verified English nameCXZL2600008 | Gan Jiang Xin Qu Ai Ze Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/22New drug · Class 1.1 | 柴黄降逆颗粒 · No verified English nameCXZL2600007 | Beijing Hui Cui Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | JKN2401注射液 · No verified English nameCXSL2600121 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2600120 | Bai Ou En Tai (Zhuhai) Pharmaceuticals Research and Development Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | 注射用ZG006 · No verified English nameCXSL2600119 | Name not romanized; Name not romanized |
| 2026/01/22New drug · Class 1 | 注射用ZG006 · No verified English nameCXSL2600118 | Name not romanized; Name not romanized |
| 2026/01/22New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2600117 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | 注射用BAT8008 · No verified English nameCXSL2600116 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/01/22New drug · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameCXSL2600114 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/01/22New drug · Class 3.3 | 西妥昔单抗注射液 · No verified English nameCXSL2600113 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Fu Xing Han Lin (Chengdu) Bio Technology Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | 注射用DB-1310 · No verified English nameCXSL2600112 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | WGI-0301 · No verified English nameCXHL2600103 | Zhejiang Hai Chang Biopharmaceuticals Co., Ltd. romanized |
| 2026/01/22New drug · Class 2.4 | 泽布替尼胶囊 · No verified English nameCXHL2600102 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | RFUS-1646片 · No verified English nameCXHL2600101 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | RFUS-1646片 · No verified English nameCXHL2600100 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | GLR2037片 · No verified English nameCXHL2600099 | Gan Li Pharma Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | GLR2037片 · No verified English nameCXHL2600098 | Gan Li Pharma Co., Ltd. romanized |
| 2026/01/22New drug · Class 2.2 | SMLT24013片 · No verified English nameCXHL2600095 | Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin Co., Ltd. romanized |
| 2026/01/22New drug · Class 2.1 | 盐酸左沙丁胺醇异丙托溴铵吸入溶液 · No verified English nameCXHL2600094 | Jinan Jing Sheng Technology Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | KBD104409片 · No verified English nameCXHL2600093 | Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/22New drug · Class 1 | KBD104409片 · No verified English nameCXHL2600092 | Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized |
100 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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