YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 344 drug applications between 16 May 2026 and 22 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 25 drug names.
2026/05/16 – 2026/05/22
- New acceptances this week
- 344
- Drugs with new generic filings (by drug name, de-duplicated)
- 25
- Accepted this week, now under review
- 51
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
344filings, 33 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 207 |
| New drug | 79 |
| Generic | 33 |
| Unspecified | 10 |
| Import re-registration | 8 |
| Import | 7 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 151 |
| Chemical drug | 131 |
| Therapeutic biologic | 59 |
| 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
25 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
218 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xian Da Tang Pharmaceutical Group Co., Ltd. romanized | 10 | 10 | 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 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | Hunan De Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | EUROAPI Germany GmbH | 4 | 4 | 0 |
| 9 | Hubei Dong Xin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Gansu Tian Shui Qi Huang Pharma 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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/22Import · Class 1 | DDY391片 · No verified English nameJXHL2600182 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/22Import · Class 1 | DDY391片 · No verified English nameJXHL2600181 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/22Import · Class 1 | BMS-986458片 · No verified English nameJXHL2600180 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/05/22Import · Class 1 | BMS-986458片 · No verified English nameJXHL2600179 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/05/22New drug · Class 1.1 | 黄氏止咳润喉散 · No verified English nameCXZL2600048 | Huang Shi Hou Kang Zhong Pharmaceuticals Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | 注射用BL-B01D1(皮下注射) · No verified English nameCXSL2600565 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | HH160注射液 · No verified English nameCXSL2600564 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | GEB-101 · No verified English nameCXSL2600563 | Beijing Yin Zheng Ji Yin Technology Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | 注射用3SC009 · No verified English nameCXSL2600562 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | QX027N 注射液 · No verified English nameCXSL2600561 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | QX027N 注射液 · No verified English nameCXSL2600560 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | GenSci144片 · No verified English nameCXHL2600617 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | GenSci144片 · No verified English nameCXHL2600616 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | BIOS0635-048片 · No verified English nameCXHL2600615 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | BIOS0635-048片 · No verified English nameCXHL2600614 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | BIOS0635-048片 · No verified English nameCXHL2600613 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 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 |
64 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.