YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 313 drug applications between 13 June 2022 and 19 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.
2022/06/13 – 2022/06/19
- New acceptances this week
- 313
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 0
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
313filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 167 |
| Generic | 49 |
| New drug | 40 |
| Import | 26 |
| Import re-registration | 21 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 221 |
| Therapeutic biologic | 50 |
| TCM | 35 |
| Biologic | 4 |
| Prophylactic 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 3 | 2 | 52 |
| 2 | Pravastatin Sodium Tablets | 2 | 1 | 2 |
| 3 | Pregabalin Capsules | 2 | 1 | 12 |
| 4 | 注射用头孢噻肟钠他唑巴坦钠 · No verified English name | 2 | 1 | 1 |
| 5 | Pantoprazole Enteric-Coated Tablets | 2 | 1 | 1 |
| 6 | Rasagiline Mesylate Tablets | 2 | 1 | 5 |
| 7 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 8 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 9 | Minoxidil Topical Solution | 2 | 1 | 0 |
| 10 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
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
181 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 10 | 2 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 9 | 9 | 0 |
| 3 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Janssen-Cilag International NV | 5 | 3 | 0 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 6 | Lian Cardiovascular Limited | 5 | 1 | 0 |
| 7 | The Wellcome Foundation Limited | 5 | 1 | 0 |
| 8 | Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | LES LABORATOIRES SERVIER | 4 | 3 | 0 |
| 10 | F. Hoffmann-La Roche Ltd | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/17Import · Class 2.1 | Isatuximab注射液(皮下注射) · No verified English nameJXSL2200088 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2022/06/17Import · Class 1 | Bemarituzumab注射液 · No verified English nameJXSL2200087 | Zai Lab (US) LLC; Zai Lab (Shanghai) CO. Ltd. |
| 2022/06/17Import · Class 1 | Bemarituzumab注射液 · No verified English nameJXSL2200086 | Zai Lab (US) LLC; Zai Lab (Shanghai) CO. Ltd. |
| 2022/06/17Import · Class 1 | M1774胶囊 · No verified English nameJXHL2200151 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2022/06/17Import · Class 1 | M1774胶囊 · No verified English nameJXHL2200150 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2022/06/17Import · Class 1 | M1774胶囊 · No verified English nameJXHL2200149 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2022/06/17Generic · Class 3 | Hydrotalcite SuspensionCYHS2200912 | Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2022/06/17Generic · Class 3 | 多种微量元素注射液(Ⅰ) · No verified English nameCYHS2200906 | Yang Pu Jing Tai Pharma Co., Ltd. romanized; Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2022/06/17Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2200904 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2022/06/17Generic · Class 3 | Minoxidil LinimentCYHS2200901 | Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2022/06/17Generic · Class 3 | Minoxidil LinimentCYHS2200900 | Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2022/06/17New drug · Class 1.1 | 心阳片 · No verified English nameCXZL2200028 | Guangzhou Zhong Pharmaceuticals University Di Yi Fu Shu Hospital romanized |
| 2022/06/17New drug · Class 1 | 6MW3511注射液 · No verified English nameCXSL2200278 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/06/17New drug · Class 3.3 | 水痘减毒活疫苗 · No verified English nameCXSL2200273 | Liaoning Cheng Da Bio Co., Ltd. romanized; Cheng Da Bio (Ben Xi) Co., Ltd. romanized |
| 2022/06/17New drug · Class 1 | QA102 胶囊 · No verified English nameCXHL2200399 | Zhuhai Qi Wei Bio Technology Co., Ltd. romanized |
| 2022/06/17New drug · Class 1 | QA102 胶囊 · No verified English nameCXHL2200398 | Zhuhai Qi Wei Bio Technology Co., Ltd. romanized |
| 2022/06/17New drug · Class 1 | SPH3127片 · No verified English nameCXHL2200396 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2022/06/17New drug · Class 1 | SPH3127片 · No verified English nameCXHL2200395 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2022/06/16Import · Class 3.1 | 注射用Susoctocog alfa · No verified English nameJXSS2200020 | Baxalta US Inc.; Vetter Pharma-Fertigung GmbH & Co. KG; Takeda (China) International Trading Co. Ltd |
| 2022/06/16Import · Class 1 | JNJ-77242113-AAC片 · No verified English nameJXHL2200148 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/16Import · Class 2.4 | Tacrolimus Eye DropsJXHL2200147 | SENJU PHARMACEUTICAL CO. LTD.; Name not romanized |
| 2022/06/16Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2200896 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2022/06/16Generic · Class 3 | Minoxidil LinimentCYHS2200895 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/06/16Generic · Class 3 | Fluorouracil InjectionCYHS2200893 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2200277 | Shanghai Jiao Lian Drug Research and Development Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | TG103注射液 · No verified English nameCXSL2200276 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized |
| 2022/06/16New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2200275 | Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | HXYT-001细胞注射液 · No verified English nameCXSL2200274 | Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized; Beijing Qing Yi Tai Ke Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | 尘螨过敏原舌下含片 · No verified English nameCXSL2200272 | Ge Lin Mian Yi Ke Xue Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | 尘螨过敏原舌下含片 · No verified English nameCXSL2200271 | Ge Lin Mian Yi Ke Xue Co., Ltd. romanized |
46 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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