YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 358 drug applications between 8 March 2026 and 14 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 33 drug names.
2026/03/08 – 2026/03/14
- New acceptances this week
- 358
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
358filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 198 |
| New drug | 83 |
| Generic | 40 |
| Import | 16 |
| Unspecified | 14 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 184 |
| TCM | 98 |
| Therapeutic biologic | 66 |
| Biologic | 9 |
| Prophylactic 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 达普司他片 · No verified English name | 3 | 1 | 0 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 3 | Tacrolimus Capsules | 2 | 1 | 2 |
| 4 | Crizotinib Capsules | 2 | 1 | 7 |
| 5 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 6 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 7 | Lactulose Oral Solution | 1 | 1 | 34 |
| 8 | Sodium Lactate Ringer's Irrigation Solution | 1 | 1 | 5 |
| 9 | Perflutren Lipid Microsphere Injection | 1 | 1 | 3 |
| 10 | Dexketoprofen Trometamol Injection | 1 | 1 | 6 |
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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ji An Tang Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 12 | 1 | 0 |
| 3 | Jiangxi Pu Li Er Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 4 | Heilongjiang Sheng Song Hua Jiang Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Karuna Therapeutics Inc. | 5 | 1 | 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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/14Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600022 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/03/14Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600021 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/03/14Import · Class 2.2 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2600079 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/14Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2600665 | Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2600664 | Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | Simethicone Chewable TabletsCYHS2600662 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | 达普司他片 · No verified English nameCYHL2600036 | Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | 达普司他片 · No verified English nameCYHL2600035 | Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | 达普司他片 · No verified English nameCYHL2600034 | Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized |
| 2026/03/14New drug · Class 1 | 舒地胰岛素诺利糖肽注射液 · No verified English nameCXSS2600049 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/03/14New drug · Class 1 | 舒地胰岛素诺利糖肽注射液 · No verified English nameCXSS2600048 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/03/14New drug · Class 1 | BTL-101注射液 · No verified English nameCXSL2600331 | Ben Dao Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2026/03/14New drug · Class 2.2 | 注射用重组葡激酶 · No verified English nameCXSL2600330 | Tong Hua Kang Yuan Yu Jin Pharma Co., Ltd. romanized |
| 2026/03/14New drug · Class 1 | 富马酸立康可泮胶囊 · No verified English nameCXHS2600042 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/13Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600078 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/03/13Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600077 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/03/13Import · Class 2.4 | Lazertinib片 · No verified English nameJXHL2600082 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/13Generic · Class 3 | Asenapine Maleate Sublingual TabletsCYHS2600659 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2026/03/13New drug · Class 1.1 | 温肺化纤颗粒 · No verified English nameCXZL2600030 | Jiangxi Zhong Pharmaceuticals University romanized |
| 2026/03/13New drug · Class 1.1 | ZGZHR-061颗粒 · No verified English nameCXZL2600029 | Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized; Nanjing Hai Ling Zhong Yao Pharmaceutical Gong Yi Technology Research Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | 注射用HLX48 · No verified English nameCXSL2600329 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | HS-IT101注射液 · No verified English nameCXSL2600328 | Qingdao Zhong Sai Bo Man Bio Technology Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | 注射用SKB315 · No verified English nameCXSL2600326 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | ABSK043片 · No verified English nameCXHL2600326 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | CMS-D001片 · No verified English nameCXHL2600325 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | ABSK043片 · No verified English nameCXHL2600324 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | CMS-D001片 · No verified English nameCXHL2600323 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | CMS-D001片 · No verified English nameCXHL2600322 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | CMS-D001片 · No verified English nameCXHL2600321 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2026/03/13New drug · Class 1 | HRS-7525片 · No verified English nameCXHL2600320 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
82 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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