YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 300 drug applications between 15 May 2026 and 21 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 24 drug names.
2026/05/15 – 2026/05/21
- New acceptances this week
- 300
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- Accepted this week, now under review
- 50
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
300filings, 32 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| New drug | 69 |
| Generic | 32 |
| Import re-registration | 9 |
| Unspecified | 4 |
| Import | 4 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 135 |
| Chemical drug | 107 |
| Therapeutic biologic | 55 |
| Biologic | 3 |
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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Adapalene And Benzoyl Peroxide Gel | 3 | 2 | 30 |
| 2 | 复方醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 8 |
| 3 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
| 4 | Procaterol Hydrochloride Oral Solution | 2 | 1 | 12 |
| 5 | Doxycycline Hyclate Tablets | 2 | 1 | 10 |
| 6 | 盐酸阿莫罗芬搽剂 · No verified English name | 2 | 1 | 15 |
| 7 | 褪黑素颗粒 · No verified English name | 2 | 1 | 12 |
| 8 | Upadacitinib Sustained-release Tablets | 1 | 1 | 43 |
| 9 | Crisaborole Ointment | 1 | 1 | 26 |
| 10 | Isosorbide Mononitrate Extended-Release Tablets | 1 | 1 | 5 |
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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xian Da Tang Pharmaceutical Group Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 10 | 5 | 0 |
| 3 | Tong Hua Jin Ma Pharma Group Co., Ltd. romanized | 8 | 7 | 0 |
| 4 | Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized | 7 | 1 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Hunan De Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Hubei Dong Xin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/21Import · Class 1 | Belantamab (GSK2857914) 注射液 · No verified English nameJXSL2600119 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2026/05/21Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600118 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/05/21Import · Class 2.2 | Nemolizumab注射液 · No verified English nameJXSL2600117 | Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd |
| 2026/05/21New drug · Class 1.1 | 归柴止痛颗粒 · No verified English nameCXZL2600047 | Shenzhen Shi Shuang Bai Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/21New drug · Class 1.1 | 芪箭颗粒 · No verified English nameCXZL2600046 | Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized |
| 2026/05/21New drug · Class 1 | RY_SW01细胞注射液 · No verified English nameCXSS2600086 | Jiangsu Rui Yuan Bio Technology Co., Ltd. romanized |
| 2026/05/21New drug · Class 1 | 注射用SKB565 · No verified English nameCXSL2600559 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/21New drug · Class 1 | IPM514注射液 · No verified English nameCXSL2600558 | Beijing Zhen Zhi Yi Xue Technology Co., Ltd. romanized |
| 2026/05/21New drug · Class 1 | SHR-7012注射液 · No verified English nameCXSL2600557 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/21New drug · Class 1 | IF001注射液 · No verified English nameCXSL2600556 | Yin Fan (Jinan) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/21New drug · Class 2.2 | BN025305H · No verified English nameCXHL2600612 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/05/21New drug · Class 2.2 | BN025305H · No verified English nameCXHL2600611 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/05/21New drug · Class 1 | YKYY033注射液 · No verified English nameCXHL2600610 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2026/05/21New drug · Class 2.1; 2.4 | ICF001吸入粉雾剂 · No verified English nameCXHL2600609 | Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized; Zhang Feng Pharma Co., Ltd. romanized |
| 2026/05/21New drug · Class 2.1; 2.4 | ICF001吸入粉雾剂 · No verified English nameCXHL2600608 | Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized; Zhang Feng Pharma Co., Ltd. romanized |
| 2026/05/21New drug · Class 2.1; 2.4 | ICF001吸入粉雾剂 · No verified English nameCXHL2600607 | Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized; Zhang Feng Pharma Co., Ltd. romanized |
| 2026/05/21New drug · Class 1 | STC009注射液 · No verified English nameCXHL2600606 | Chengdu Nuo He Cheng Tai Bio Technology Co., Ltd. romanized |
| 2026/05/20Generic · Class 3 | 氨氯地平缬沙坦氢氯噻嗪片 · No verified English nameCYHL2600063 | Jiangsu Yong An Pharmaceutical Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | iNK-1001注射液 · No verified English nameCXSL2600555 | Shanghai Ai Sa Er Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | 人脐带来源3D间充质干细胞注射液 · No verified English nameCXSL2600554 | Sai Pu Bio Technology (Changchun) Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | 注射用LM-302 · No verified English nameCXSL2600553 | Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized; Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | CT1190B CAR T细胞注射液 · No verified English nameCXSL2600552 | You Kai Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | SHR-7590注射液 · No verified English nameCXSL2600551 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | SHR-7590注射液 · No verified English nameCXSL2600550 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | SAL0195注射液 · No verified English nameCXHL2600605 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized; Shenzhen Shi Ge Bi Jia Fen Zi Drug Innovation Center Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | HW243040片 · No verified English nameCXHL2600604 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | HW243040片 · No verified English nameCXHL2600603 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | PG-040滴眼液 · No verified English nameCXHL2600602 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | PG-040滴眼液 · No verified English nameCXHL2600601 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/20New drug · Class 1 | PG-040滴眼液 · No verified English nameCXHL2600600 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
51 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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